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Novo Nordisk Pharmatech and Brenntag Specialties, Inc. (BSI) have entered into a distribution agreement for Pharmaceutical Grade Quaternary Ammonium Compounds into the Pharmaceutical and OTC Markets in the United States & Puerto Rico.
“Our partnership with Novo Nordisk Pharmatech demonstrates our commitment to providing innovative solutions and differentiated value to our customers by strategically expanding our principal relationships and product lines.” said Steve Brauer, President of Brenntag Specialties, Inc. “The product line offering from Novo Nordisk Pharmatech furthers our reach into the pharmaceutical, OTC, and personal care markets”
Novo Nordisk Pharmatech manufactures its Pharmaceutical Grade Quaternary Ammonium Compounds in accordance with the highest cGMP standards in the market- the ICH Q7A Guide for Active Pharmaceutical Ingredients.
The new product offering includes:
- Benzalkonium Chloride and Cetrimide solutions
- Benzalkonium Chloride 95%
- Crystalline Cetrimide and Cetyl Trimethyl Ammonium Bromide
An innovative synthesis process makes Novo Nordisk Pharmatech a leading supplier of crystalline quaternary ammonium compounds. They have excellent antimicrobial and surface-active properties rendering them suitable for a variety of applications. High levels of purity make them particularly suited for specialized pharmaceutical applications, such as polysaccharide vaccine production and precipitation of DNA (gene therapy) vaccines. Quaternary ammonium compounds act either as preservatives or active ingredients in many ophthalmic, nasal, oral and topical drugs and in a variety of surgical scrubs, medicated solutions, ointments and creams.
Novo Nordisk Pharmatech manufactures quaternary ammonium compounds using only high-purity tertiary amines with various alkyl chain lengths, normally ranging from C12 to C18. The properties of our quaternary ammonium compounds can vary according to the alkyl chain length, but they all offer common attributes including:
- Proven record of efficacy against a broad spectrum of microorganisms
- Effective through a wide pH range
- Odourless and colourless in product formulation
- Surface active / adhesive cationic agent
- Very stable, proven under ICH Q1 Stability Protocols
- Five-year shelf life
- Drug Master Files available for reference
Brenntag, the global market leader in chemical distribution, covers all major markets with its extensive product and service portfolio. Headquartered in Mülheim an der Ruhr, Germany, the company operates a global network with more than 490 locations in 72 countries. In 2014, the company, which has a global workforce of more than 13,500, generated sales of EUR 10.0 billion (USD 13.3 billion). Brenntag connects chemical manufacturers and chemical users. The company supports its customers and suppliers with tailor-made distribution solutions for industrial and specialty chemicals. With over 10,000 products and a world-class supplier base, Brenntag offers one-stop-shop solutions to around 170,000 customers. This includes specific application technology, an extensive technical support and value-added services such as just-in-time delivery, product mixing, formulation, repackaging, inventory management and drum return handling. Long-standing experience and local excellence in the individual countries characterize the global market leader for chemical distribution.
Novo Nordisk Pharmatech A/S has entered into an agreement with Signet Chemical Corporation Pvt. Ltd. for the distribution of their pharmaceutical range of quaternary ammonium compounds (FEF® Quats) to the healthcare industry in India, Bangladesh and Sri Lanka.
Mr. Harish Shah – managing director of Signet commented on this new collaboration: “We are pleased to be associated with Novo Nordisk Pharmatech which is the leading supplier of Quats to the pharmaceutical and biopharmaceutical markets. Novo Nordisk Pharmatech’s FeF® Quats complement our existing portfolio of excipients used especially for ophthalmic, nasal and topical dosage forms”.
Novo Nordisk Pharmatech A/S manufactures Quats (Benzalkonium Chloride, Cetrimide and Cetyl Trimethyl Ammonium Bromide (CTAB), including customised grade, in accordance with cGMP (ICH Q7) for active pharmaceutical ingredients which is the highest available quality standard. Their products comply with the latest pharmacopoeial standards and are extensively supported by CEPs, DMFs and a comprehensive package of regulatory and quality assurance documents. Their manufacturing site (Koege, Denmark) is audited by the Danish Medicines Agency and US FDA.
“We are very happy to work with Signet as our distribution partner for pharmaceuticals. Novo Nordisk Pharmatech’s FeF® Quats products fit perfectly with Signet’s wide range of excipients enabling the customers to take advantage of these synergies. We wish to give the best service to our customers and the local pharma team of Signet are experts in working with customers to support their product development” says Steve Profit, sales & marketing director at Novo Nordisk Pharmatech A/S.
Signet, is India’s leading pharmaceutical excipient distributor company offering a broad range of excipients under one crest. Founded in 1986, Signet Chemical Corporation Pvt. Ltd. is a pioneer in the excipients business in India. Since its inception, Signet has combined technical expertise with commercial support to provide its clients accurate information and exceptional product value. With 95 qualified and well-trained members, the Signet team has an excellent understanding of the intricacies of the market and has strong relationships with key partners to take the company forward. Signet has a turnover of approx. 174 million US dollars with around 100 employees serving India, Bangladesh, Nepal and Sri Lanka.
The grand opening of Novo Nordisk Pharmatech A/S new branch office in Singapore on October 15th 2019 was celebrated together with customers, employees and other stakeholders.
At Novo Nordisk Pharmatech A/S we opened our first overseas representative office with a Grand Opening ceremony for our new branch in Singapore. The event marks a significant new expansion milestone in the 70-year history of Novo Nordisk Pharmatech. The new branch office at 152 Beach Road, #17-04 The Gateway East has been in operation since September, serving as a hub to expand Novo Nordisk Pharmatech’s business across Asia.
The region is a rapidly growing market for our varied portfolio of leading-edge Quaternary ammonium (QUATS) and other compounds, as well as recombinant human insulin AF.
Novo Nordisk Pharmatech Managing Director and Corporate Vice President Rasmus Hother Le Fevre attended the Grand Opening ceremony and reception for customers, employees and other stakeholders.
“We are thrilled to be expanding our footprint into Asia,: said Mr. Hother Le Fevre.
“This new office is in close proximity to some of the world’s leading biopharmaceutical companies with direct access to leading regional clusters of biopharma and biotech development that are the main focus of our own activities,” he explained.
“Our new Singapore presence enhances our ability to deliver the high quality QUATS and recombinant insulin for cell culture media to the pharma and biopharma industries,” he added.
“A local Singapore branch office was a logical step in our business growth strategy and presents a superb opportunity for Novo Nordisk Pharmatech to strengthen our presence in a region where we have been increasingly active for several years,” said Mr. Hother Le Fevre.
We are pleased to announce that Chantale Julien has re-joined Novo Nordisk Pharmatech on January 1st, 2020. Chantale will be acting as Global Product Manager for the FeF Quats and Insulin Human AF products.
Chantale has previously worked for Novo Nordisk Pharmatech for a period stretching over almost 13 years, where she has been acting as Product Manager, Regulatory Affairs Manager and Project Manager. She has been involved in establishing the Insulin Human AF distribution from Novo Nordisk Pharmatech and brings back a wide experience in the API and excipient sectors for our antimicrobial quaternary ammonium compounds.
We are happy to have an experienced employee back on the team. You are welcome to contact Chantale if you need technical advice, for new product-related projects, and general product information. You can find here contact information here.
At Novo Nordisk Pharmatech we always strive to develop and provide high quality products and services that place emphasis on the health and safety of our consumers and customers. As of January 1st, 2020 our new Director of Manufacturing is John Halfdan Boiesen. John will be heading up the NNPR manufacturing facility ensuring that we deliver high quality products in regulatory compliance.
Part of the Manufacturing responsibility is to ensure that NNPR has all necessary permissions to operate and operate with minimal environmental impact.
John Boiesen started his career at Novo Nordisk in 2005 as a Supply Chain Graduate and since 2007, John has held various leadership positions in Novo Nordisk A/S – Product Supply within supply chain, warehouse and business support. We are happy to welcome John and if you need to contact him, please find his contact information here.
In our ambition to build and maintain customer loyalty all around the world, Novo Nordisk Pharmatech A/S started using NPS (Net Promotor Score) in 2014. It was – and still is – a simple tool to clarify if our customers are as satisfied as we think they are and whether they would recommend us to others. We also receive great input in the comments on where we can improve our business.
Since 2014 we have significantly improved our NPS score*, and in 2019 we had an impressive average score of 76. NPS scores range from -100 to 100.
Do you also want to become one of our loyal customers and ambassadors? You can always find our contact information here.
* Subtracting the percentage of Detractors from the percentage of Promoters gives the Net Promoter Score. Promoters (score 9-10) are loyal enthusiasts. Passives (score 7-8) are satisfied but unenthusiastic customers. Detractors (score 0-6) are unhappy customers. NPS score can range from a low of -100 (if every customer is a Detractor) to a high of 100 (if every customer is a Promoter).
Novo Nordisk Pharmatech A/S is continuously reviewing the likely impact upon its supply chain if product availability is affected by the consequences of the coronavirus. Presently, we conclude that the impact on current product portfolio is very limited. We will keep our customers informed of developments that might affect product supply and demand if the situation changes.
You can read the full statement here
The vaccine industry is challenged to produce large quantities of vaccines in a rapid and cost-effective way. Major changes to current bioprocesses are both difficult and very expensive to implement. Using HEK293, it has been demonstrated that addition of recombinant human insulin to commercially available chemically defined media can be used as a supplement to increase VCD and specific viral yield.
If you want to know more you can read the application study, which National Research Council Canada has created in collaboration with Novo Nordisk Pharmatech A/S here.
COVID-19: Looking for an effective antimicrobial agent? Benzalkonium Chloride (BKC) is recommended by several national agencies as an effective agent to control infection by Covid-19.
BKC, a Quaternary Ammonium Compound (or Quat), is an ideal antimicrobial agent with proven efficacy. It is broadly used in topical and wound care products such as hand sanitizers, antiseptic liquids, foams, gels and cleansing wipes. BKC acts on a wide range of microorganisms, including enveloped viruses such as influenza and Corona, gram+ and gram- bacteria such as MRSA, moulds and yeasts such as Candida albicans.
As opposed to bacteriostatic/fungistatic compounds which only prevent micro-organisms from dividing (growing), Quats are bactericidal/fungicidal: They will kill micro-organisms in a growth phase or not. Quats are effective at all pH levels, and their effectiveness increases when the pH increases. The higher the pH, the lower the concentration needed to obtain an antimicrobial effect.
No matter the formulation, products coming in contact with either healthy or damaged epithelial tissue, must be manufactured with great care, using the best quality and safest ingredients. All our Quats are manufactured cGMP, at the highest purity and grade.
You can read more here.
Whether you are manufacturing bacterial or viral vaccines, you want to minimize risks in your process by only using the purest and safest ingredients and materials.
CTAB, called Cetrimonium Bromide or Cetyl Trimethyl Ammonium Bromide, is a powerful cationic surfactant for use in vaccine downstream purification steps.
It is recommended by the WHO for the precipitation step of polysaccharide-based bacterial vaccines. It is also used as a purification agent of viral antigens, whether the vaccine is egg-based, cell-based or recombinant.
Utilizing chttps://www.linkedin.com/company/68003/GMP manufactured, pharma grade ingredients and processing aids can help you secure your vaccine production and minimize your risks.
As a unique feature on the market, Novo Nordisk Pharmatech A/S´s high purity CTAB is manufactured in cGMP API grade.
Read more on CTAB in vaccines here.
To enhance cell growth and viability for your innovative biologics, you can work with the leading supplier of recombinant insulin, Novo Nordisk Pharmatech.
We source our recombinant insulin directly from our mother company Novo Nordisk, the world’ s largest insulin producer. Thanks to our solid supply chain, you can keep development on track, production flowing, and products supplied to hospitals and patients.
Whether you work with HEK, CHO, SF9 insect, CAR-T or stem cells, you will be provided with the right quality ingredients for your projects, supplemented with appropriate documentation – even tailoring our solutions to match your specific application needs.
Why grow your cells with our insulin? Many of the world´s leading pharmaceutical companies already do. Enhanced viability and yield in your production, combined with our manufacturing and quality control, precision delivery, risk mitigation strategy and continuous availability, are only a few reasons.
Do you want to know more about our Insulin Human AF?
Almost four weeks has passed since the first announcement came that we had to rearrange our daily life to break the Corona infection chain. Plans were made in regard to prioritizing within the frame set by the authorities and it was quickly evident that we are change ready and flexible in solving that task. This way we can still ensure that our customers will receive the same high-quality products as always.
One thing is the professional part of working and finding new solutions to that. Another thing is the importance of the social element, which becomes very distinct in a situation like this. Many online meetings are being held in and across departments. Even social events are held online. The Novo Nordisk Pharmatech (NNPR) United spirit has shown itself from its best side.
Should you have any questions to the current situation at the time being, please do not hesitate to contact us here.
Our full cGMP processes make Novo Nordisk Pharmatech the leading supplier of pharmaceutical grade Quats (quaternary ammonium compounds) for a wide range of applications.
Benzalkonium Chloride, Cetrimide and Cetrimonium Bromide (CTAB) in cGMP grade are particularly suited as active ingredients and excipients in pharmaceuticals, or process aids for biopharmaceuticals.
Proven under ICH Q1 conditions, our Quats are very stable. They are powerful antimicrobial surfactants, soluble both in aqueous and oily phases and basically active at all pH ranges. They can be used for a large number of applications requiring high purity and quality, such as ophthalmics, nasal sprays, wound care/topical/oral/dental and veterinary products, medical devices, vaccine and gene therapy processes.
We offer an extensive range of documentation to help you meet registration and regulatory requirements. This includes multicompendial analysis, and access to regulatory documentation, such as Drug Master Files and our Ph.Eur. Certificates (CEP) for Benzalkonium Chloride and Cetrimide.
Learn more about possible applications here.
Imagine a blockbuster drug. Now keep it on track.
Every new idea needs great execution. We can help, with a reliable supply of the highest quality ingredients for the biopharmaceutical and pharmaceutical industries:
Recombinant Insulin for cell growth media and pharmaceutical grade Quaternary Ammonium Compounds. Both manufactured to cGMP standards.
Our proven record of precision delivery and product quality allows you to keep development on track, production flowing, and products supplied to hospitals and patients. Giving you the security, you need to focus on the next big breakthrough.
Our experts are always ready to support you. You can find their contact information here.
Every year, we at Novo Nordisk Pharmatech publish a single, integrated report on our performance.
Read the Annual Report 2019 here and learn more about our accomplishments and results, our way of doing business and our financial statements.
Did you know that we at Novo Nordisk Pharmatech have 70 years of extensive experience supplying Quats (quaternary ammonium compounds) for the biopharmaceutical and pharmaceutical industries? Do you also know the story behind our company name?
In 1949 Ferrosan Fine Chemicals factory was established. In 1986 we were acquired by Novo Nordisk. In 1992 the name was changed to FeF Chemicals A/S – and on September 1th 2015 we changed to the name, we have today: Novo Nordisk Pharmatech A/S. At the same time our current Corporate Visual Identity was created including the well-known Novo Nordisk bull.
All the way we have maintained our position as the best supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries.
Are you interested in knowing more about our way of doing business – and about our accomplishments and results? You can learn more in our Annual Report for 2019 here
Novo Nordisk Pharmatech has been a CO2 neutral company since 2018. This environmental improvement is due to an agreement from 2015 on energy distribution, which ensures we are only supplied with renewable energy, produced by windmills. In 2018, another agreement was made regarding our gas consumption, which now comes from Biogas. This means that we have zero CO2 emissions from energy consumption. In 2019 we also committed to the Novo Nordisk Circular for Zero environmental strategy. This means we will strive to have zero environmental impact by 2030.
We are committed to the following targets, according to our environmental policy:
- We reduce our waste volumes, noise impacts and emissions into the air
- We reduce our CO2 emissions
- We run our business safely by conducting environment and risk assessments for all activities
- We will continue to systematically minimize the environmental impact when we develop new products and processes
- We will continue to encourage our customers to co-operate in the development of environmentally-sound products and services
- We regularly report on environmental efforts and performance
- We maintain an open and trustworthy dialogue with our stakeholders
- We encourage staff environmental awareness to ensure an environmentally-sound culture
How do we ensure the quality of materials and products? What are the benefits of using cGMP Quats as excipients? And how does Novo Nordisk Pharmatech ensure to stay on top of the pace of technology change?
Did you have the chance to read the article in Pharma Focus Asia, where our Corporate Vice President Rasmus Hother le Fevre talks about the industry challenges on product quality and how to ensure a good quality?
If not, you can read the article here.
We will develop our employees. This is one of our goals at Novo Nordisk Pharmatech. Therefore, from the first day we encourage our employees to think about their continuing education. Not necessarily for the position they have now. But to make sure that they are ready for any future positions. Internally or externally.
An example of this is our Global Marketing Manager Marie-Louise Lyster Andersen. Marie-Louise started working at Novo Nordisk Pharmatech on January 1th 2020 and has already started her first training with an external partner:
“It is very satisfying to work at a company that is not reluctant in terms of education, even though my seniority is not that high. But at NNPR, I have been encouraged to expand my skills as part of my Individual Development Plan. Besides the benefits of increased skills, it naturally affects my job satisfaction in a positive way.”
Do you also want to be part of Novo Nordisk Pharmatech? You can always find our vacant positions here.
You can increase viable CHO cell density by supplementing with recombinant Insulin Human AF. CHO cells are one of the most widely used platforms to produce biopharmaceuticals.
Increased demand for safety and reliability has moved the standard for CHO cell culture media from Serum to Serum free, and further on to chemically defined media.
UAB (Universitat Autònoma de Barcelona), in collaboration with Novo Nordisk Pharmatech A/S, has shown that the addition of animal origin free insulin to three leading commercially available, off-the-shelf chemically defined media, resulted in significant increases in viable cell density under batch-mode culture. This led to improve cell growth up to 53 % and 66% of targeted protein production.
In addition to this benefit, insulin has been proven to aid in the expression of proteins that are difficult to express.
You can read or download the result of the study here.
Our innovation: A wide range of capabilities are available at Novo Nordisk Pharmatech A/S within the various departments; Sales and Marketing, R&D, Manufacturing, Quality, Business Support and HR & Communication. They are all critical for us to run the business and innovate. The following “Core Capabilities” are fundamental to the future growth of our company:
- Designing and developing silica gels: We have long history of continuously reducing the cost for Novo Nordisk of producing insulin by providing robust silica gel and developing processes for increasing their life time.
- Advanced microanalysis: At our Microanalysis Centre our team supports Novo Nordisk with state-of-the-art microscopy and spectroscopic support. This capability is also critical for the development of new chromatographic resins.
- Organic chemical synthesis manufacturing: We have from the outset produced Quats by organic synthesis manufacturing and has led to our solid experience.
- cGMP embedded throughout the organisation: Biopharmaceutical companies are required to operate in accordance to cGMP to ensure patient safety. For us to be a preferred supplier to the biopharmaceutical industry cGMP therefore is a key capability.
Contact us for further information here.
Our customers depend on us to deliver their needed products – even when we are facing a pandemic as COVID-19. While our customers depend on us, we depend on our employees. Without them and their ability to work under changed conditions, we could have faced great problems the last couple of months.
Meet our Supply Chain team. As the COVID-19 pandemic was advancing, our Supply Chain team faced a big challenge: The increased amount of potential shortages that could stop production to the great disadvantage of our many customers. At the same time, they had to adapt to working remotely, handling the work/life balance and ensuring to stay safe and healthy.
Quick reaction in evaluating risks, around the clock communication with suppliers, acceptance to constantly navigate and plan across many uncertain scenarios – and finally the desire to give it all for the company and our clients. This was their key to succeed. Of course, the support from the other teams at Novo Nordisk Pharmatech and our suppliers was also essential. The high degree of flexibility and adaptability across all stakeholders ensured that the inbound supply and production planning succeeded.
Europe´s leading Bioprocessing event is taking place July 13-17 – and Novo Nordisk Pharmatech is an active part of the event. You will here get much more information about our Insulin Human AF and how it can help you in your upstream processes.
The conference and exhibition was original planned for April and then moved to new dates due to COVID-19. Now it will be held as a 100% virtual event.
Do you want to visit our virtual booth and have a chat with Gernot Stadlmann, Timur Özbay or Lene Hoffmeyer Nielsen? You can register for the FREE virtual exhibition visitor pass here.
The virtual exhibition is featuring 50+ bioprocessing technology displays and the virtual poster hall featuring 20+ peer-submitted scientific posters.
If you are not able to attend and have questions for us, you can always find our contact information here.
Long seniority and high professionalism are both important cornerstones in our business. Almost half of our colleagues have a seniority above 10 years in the Novo Nordisk Group. And we actually have 9 employees (out of 193 in total) with a seniority higher than 30 years.
Meet Anne Ammitzbøll. Anne has worked in the Novo Nordisk Group for 35 impressive years. She started as a Laboratory Technician and has been in her current position in our QC (Quality Control) in Køge since 1998.
“My position and department have changed a lot during the years and thanks to my versatile assignments, 22 years in QC has not felt like a long time. At Novo Nordisl Pharmatech we all know each other and if you need help or information, you can easily approach your colleagues directly regardless of department or level in the organisation. Although over the years we have increased the number of employees from 60 to close to 200.”
Anne is currently studying an Academic Management. We are excited to see what the future brings for her.
Supply chain safety, quality and reliability are key to all our Quats and Insulin Human customers. Here is how we can help you secure your supply chain, from sourcing raw materials to delivering your products as promised – even in a global crisis.
A secure supply from a pharma organisation
As part of a large pharma group, we are uniquely positioned to help both our Quats and Insulin Human customers secure their supply chains. We source our Recombinant Insulin directly from our parent company Novo Nordisk, the world’s largest producer, for a secure supply of high quality insulin. Being part of a large organisation also puts us in a strong position for sourcing raw materials from our key Quats suppliers.
We are a specialist and dedicated manufacturer of Quats in an unequalled, full cGMP grade. This reduces your supply chain risk for products such as Benzalkonium Chloride, compared with non-pharma manufacturers of multiple products or APIs. You can be sure of where our products come from and that they meet all the necessary specifications.
(You can download the article here.)
Quality and consistency you can rely on
Insulin production is complex: any variation in the manufacturing process, both upstream and downstream, can have serious effects on the insulin’s consistency. For the same performance every time, consistency is a must. With very few manufacturing batches a year, the large scale of our manufacturing and our highly standardised processes ensure product consistency. With a long history of compliance, our Insulin Human is manufactured in cGMP facilities, following our ISO 9001 quality system. It is analysed according to the current European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP).
All our Quats products are manufactured according to cGMP and ICH Q7 guidelines. This ensures the right quality products, with a high degree of consistency. Our multi-compendial range of products follows the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). Some Quats products also follow the Japanese Pharmacopoeia (JP) or the British Pharmacopoeia (BP). You therefore have complete assurance that products will meet regulatory guidelines. All our Quats activities are gathered in one site in Denmark, making supply chain audits even easier.
We provide a simple, ‘one-stop’ solution to regulatory compliance for both our Quats and Insulin Human customers, with up-front access to a full package of certificates from authorities, qualification dossiers, stability and analysis documents, and more. We also have a dedicated customer support department to provide a swift response to any questions you might have.
Delivering as promised around the world
Our Quats products are sold globally in more than 70 countries across Europe, Asia, North America, South America and Africa. We supply some of our customers directly, but we are also supported by a network of global distributors across North America, Europe, Asia, Australasia and India. This gives customers access to a local supplier and point of contact for their products. In-stock pharmaceutical products can be shipped within a week, and our entire range of products is offered in a variety of packing solutions, meeting demands for small- and large-size packaging. Our Quats products are also distributed in line with GDP and Known Consignor.
Insulin Human is filled in our own classified room facilities using tamper-proof packaging. These are placed in approved thermo-containers together with dry ice to ensure that the product is kept below the recommended maximum temperature during shipment. Customers might be surprised to learn that we do not have a requalification process; if the product is not delivered, or re-icing is not performed, the product is simply scrapped. Local distribution centres – in Indiana, USA, and near Copenhagen, Denmark – also provide short lead-times and precision delivery worldwide.
Ensuring business continuity during crisis
Covid-19 has put supply chains to the test, with gaps rapidly emerging. However, it has been more or less business as usual for us. As a pharma company, our business was deemed essential by governments around the world. By working closely with our customers, we are delivering our products as promised and without disrupting planned manufacturing processes.
We are continuing to monitor the situation closely, and of course we have business continuity plans in place to ensure ongoing, safe operations, as well as product stockpiles to cover customer requirements.
For more information, please contact:
Insulin: Timur Özbay at [email protected]
Quats: Phil Stafford at [email protected]
You can download the article here.
We are taking our ambition to be as green as possible to a new level. Now by offering our employees the possibility to commute in a green way.
As a natural consequence of our Circular for Zero environmental strategy we have established 10 parking spaces with charging stations for electric vehicles. This makes it even more attractive to commute in a green way.
Our employee Lene Hoffmeyer Nielsen is very pleased with the new parking spaces:
“The new charging stations at our site is the main reason why we have ordered a Plug-in hybrid car. The possibility to get the car charged during the day and not having to have a charging station at home makes a huge difference. This way I´m also contributing to reducing the CO2 level, which gives a nice “green” feeling.
At Novo Nordisk Pharmatech we have been CO2 neutral since 2018. Our gas consumption comes from Biogas and we are only supplied with renewable energy, produced by windmills. This means that we have zero CO2 emissions from energy consumption. Even our grass is mowed by a robotic automower which runs on our power from windmills.
If you wish to read more about our strategy, you can do this in our Annual report.
Our recombinant insulin is a key component in serum free growth media for mammalian cells. It is used in many cell lines, such as CHO-s, HEK 293 or Sf9, for the manufacturing of monoclonal antibodies, virus vaccines and gene therapy products. It can also be used in other biological drug products approved by regulatory bodies worldwide, including FDA and EMA.
We maintain our position as the leading supplier of insulin for cell culture processes by providing excellence at every step of the supply chain – beginning with the quality of our insulin, which is sourced directly from Novo Nordisk, the world’s largest producer.
We also draw upon Novo Nordisk’s 97 years of experience within the Biopharmaceutical industry and access to a large number of in-house specialists who can assist with advice, even from early product development stages. This makes us a reliable partner to provide exactly the right quality ingredients for a range of biologic application needs.
Find more information about our recombinant insulin for innovative biologics here.
Whether you are an employee, a manager or a business owner, we share a common goal – we don’t want anyone to get hurt on the job. Therefore, employee health and safety conditions are incorporated in all our work tasks.
We are now certified to ISO 45001, the newest ISO standard within OH&S (occupational health & safety). ISO 45001 has become one of the most eagerly awaited standards in the world and is set to drastically improve levels of workplace safety.
Compared to the former benchmark for OH&S, ISO 45001 considers both risk and opportunities and includes the views of interested parties. ISO 45001 is also process-based and dynamic in all clauses.
This helps us in our risk assessment and to ensure that our employees go home from work just as safe as when they showed up.
With regulations tightening and supply chains shifting, we asked a Brenntag expert with more 40 years’ experience in the industry how Brenntag and Novo Nordisk Pharmatech can support the US pharma market – now and in the future.
Brenntag is the global market leader in chemical and ingredients distribution. Brenntag Specialities is dedicated to high value pharmaceutical APIs, pharma excipients, personal care, nutritional and material science products, with exclusive relationships with the manufacturers it represents, including Novo Nordisk Pharmatech.
(You can download the article here.)
Joseph Giaimo is Senior Director of Sales for Life Sciences and Marketing Manager for the Novo Nordisk Pharmatech line of pharmaceutical Quats, including Benzalkonium Chloride. “The most important application area for us is ophthalmics,” he says. “Novo Nordisk Pharmatech’s Benzalkonium Chloride is a potent antimicrobial used in most ophthalmic solutions. It’s used in very small quantities, but it’s critical to maintaining the integrity.”
The only company manufacturing under cGMP and ICH Q7
“One of the biggest challenges for our customers is to be able to purchase very high quality multi-compendial Benzalkonium Chloride made under both full pharma cGMP and ICH Q7 regulations to be used as a pharma excipient and as a full API,” explains Joseph Giaimo. “Novo Nordisk Pharmatech is the only manufacturer in the world who produces pharma grade Quats under cGMP and ICH Q7 regulations. They produce the highest quality Quats in the world and have extreme consistency lot to lot, and year to year.”
“We deal with multi-national companies that manufacture in the US and export throughout the world, so they need multi-compendial products,” he adds. “Novo Nordisk Pharmatech’s Quats meet the European, US, British and Japanese pharmacopoeias, which is a great asset for our marketing.”
Meeting rapidly changing regulatory requirements
“Regulatory compliance is perhaps the biggest challenge in the pharma market today. The regulations covering pharma products here in the US and globally are under constant change and need constant monitoring to remain in compliance,” says Joseph Giaimo. “Full transparency between Brenntag Specialties and Novo Nordisk Pharmatech regulatory departments allows for immediate Change Control Notification and document updates. Novo Nordisk Pharmatech has a dedicated portal on its website that instantly and automatically sends any changes in documentation to our regulatory team and myself.”
A partnership prepared for future market trends
Looking ahead, Joseph Giaimo predicts that products used in the US pharma and personal care markets will be under increasing scrutiny for safety and effectiveness:
“Manufacturers will need to tighten up Standard Operating Procedures and step up their regulatory compliance in general. Companies that cannot meet these challenges
will fall by the wayside.”
“We also believe there will be significant ‘re-shoring’, moving pharma production back to the US, as recent disruptions in the global supply chain due to COVID-19 have demonstrated,” Joseph Giaimo shares. “We expect to see less dependency on manufacturers from China and India, and a higher concentration of high quality US and EU producers – including of course Novo Nordisk Pharmatech. Brenntag stocks Novo Nordisk Pharmatech products locally in a certified GMP distribution centre in Philadelphia for immediate dispatch throughout the US.”
For more information regarding Novo Nordisk Pharmatech´s cGMP manufactured Quats products, please contact International Sales Manager Phil Stafford at [email protected]
You can download the article here.
“I feel like as an intern I got the opportunity to explore my field of study within a company which values a student’s perspective, and does not hesitate to give its interns responsibility in the task they solve,” explains Emma Lillebro Striib Nielsen, former student intern and now student assistant.
Every semester, we welcome local and international students to gain hands-on experience in a leading global pharma company. For the six months they’re with us, each intern becomes an integral part of the team, with meaningful responsibilities – and challenges – that will allow them to grow and distinguish themselves in future work environments.
We believe it’s our responsibility to nurture the industry’s next generation of talent. But, equally, we also gain so much from our interns’ broad range of educational and cultural backgrounds.
“Novo Nordisk is a name with a lot to live up to and it can almost feel overwhelming. But going in through the gates, I was meet with smiling employees and a positive atmosphere,” says Matthieu Francois, our latest Sales and Marketing intern from France studying Master´s in Industrial Sales Engineering. “During two days of onboarding, every employee made me feel at home and motivated to give my best.”
How can you mitigate your raw material risk, especially during a pandemic? The COVID-19 crisis has reinforced the importance of having a strong supply chain and a risk-management and business-continuity plan.
What selection criteria and which risks have you identified? To understand risks related to supply, demand, material supplier capacities, and so on, you need information that can come only from communicating with your supplier about the stability of supply, production capacity, and transportation and distribution chain.
Read about the complete capabilities review and learn more about raw material risk mitigation here.
The article was published in the BPI Industry Innovators Issue 2020/2021.
With Insulin Human AF, you avoid the risk of impurities such as mycoplasmas, which can pass line to line from the upstream bioreactor and contaminate your whole line.
Our high quality Insulin Human AF is manufactured by our parent company, Novo Nordisk, a leading supplier of insulin for almost 100 years.
Novo Nordisk manufactures its Insulin Human AF in cGMP facilities, following an ISO 9001 quality system. With very few manufacturing batches a year, the large scale of our manufacturing and our highly standardised processes ensure product consistency. The insulin is analysed according to the current European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP).
You can be sure you get the same high quality product, time after time, reliably delivered through local distribution networks. Our comprehensive documentation package and tailored support, which continues through the whole product life cycle, gives you total peace of mind.
Do you also want to avoid the risk of impurities? Contact us here.
Do you want to join CPhI Festival of Pharma for free? The world’s largest pharmaceutical virtual meeting is launched to bring the global pharma industry together online. The 10-day event (October 5-16, 2020) will welcome thousands of attendees and offers you best-in-class networking, learning and sourcing opportunities.
Novo Nordisk Pharmatech A/S will maintain the longstanding relationship with CPhI and is Platinum Sponsor of the online event, sponsoring the keynote: “How will lessons learnt from COVID-19 shape new EU pharmaceutical policy”. This hour long session will be webcast Monday October 5, beginning at 1100 hrs. CET.
Join us and get knowledge from a world-class line-up of expert speakers.
Sign up for free here.
Why use recombinant Insulin in DoE for your media development?
On October 6-7 we will make our debut at Cell Series UK virtual conferences. We are contributing to the Cell Culture and Bioprocessing conference track on Cell Media with the presentation: Why Use Recombinant Insulin in DoE For Your Media Development.
The presentation will feature a case study by the University of Barcelona based on the use of a DOE model for determining optimal levels of nutrients in cell culture media for CHO-S cells. We will as well as examine the use of human insulin in association with CHO cells to produce mabs and also with HEK-293 cells to replicate influenza virus antigens for vaccines.
If you are not attending Cell Series UK, but still would like to see the presentation, please contact us here.
If you want to reduce the risk for your raw materials, pharma-grade Quats is the way to go – both for APIs and expients. We are at Novo Nordisk Pharmatech specialists and a dedicated manufacturer of Quats in an unequalled, full cGMP grade.
With our stringent Quality Management System, we ensure the right quality products, with a high degree of consistency. We receive excellent ratings in audits from our customers and authorities, including the FDA and EMA.
Our multi-compendial range of Quats complies to the highest regulatory guidelines, including ICH Q7, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). Some Quats products also follow the Japanese Pharmacopoeia (JP) or the British Pharmacopoeia (BP).
You can be sure you get the same high-quality product, time after time. Our comprehensive documentation package and tailored support, which continues through the whole product life cycle, gives you total peace of mind.
Do you want to read more about some of the applications where Quats are used?
Within the biopharma industry, consistency is key – not just from your product but from your supplier. We spoke with two experts from Thermo Fisher Scientific about how they meet their customers’ challenges together with Novo Nordisk Pharmatech.
Thermo Fisher Scientific is one of the largest suppliers to the biopharma industry, supporting both commercial bioproduction and biosciences. The company serves a broad range of customers. In bioproduction alone, Thermo Fisher Scientific works with every application of cell culture, from vaccines, to cell and gene therapy and even with artificial meats. The one thing all its customers have in common? The need for quality.
(You can download the article here).
A reputation for quality that opens doors
Quality is critical for cell or gene therapy, explains Abhijeet Kohli, a product manager responsible for Thermo Fisher Scientific’s cell culture and media portfolio. Meanwhile, biosimilar manufacturers need to ensure that their quality fits that of originators as closely as possible. In the vaccine space, a higher quality product delivers higher value by providing a good dollar per gram value.
“Insulin is a very important raw material,” says Abhijeet Kohli. “In general, the Novo Nordisk brand carries with it a higher value. Typically, for a cell or gene therapy application where quality is paramount, our customers prefer a Novo Nordisk type insulin for their products versus a different brand.”
Quality is also a key consideration for Sourcing Manager Vince Saint. Tightening regulations have increased the validation new customers need to do. This makes customer onboarding a long and challenging process for Thermo Fisher Scientific. But Novo Nordisk Pharmatech is able to help here too. “Customers are very aware of who the key players are in the market,” says Vince Saint. “The reputation of Novo Nordisk
Pharmatech precedes itself, as a top tier manufacturer with a great quality record historically. This is very helpful when working with new customers, and something we can lead with.”
A partnership built to meet future challenges
“Novo Nordisk Pharmatech is a top performer across our supplier measurements. But it’s different from just supply and order – this is a partnership,” Vince Saint explains. “We have a good line of communication back and forth through our contact, Timur Özbay. This really lends itself to having a complete and functioning operation, with high quality, great delivery performance, and really good communication between our companies.” According to Vince Saint, this partnership was instrumental during the coronavirus pandemic: “COVID-19 hasn’t affected this part of the business, since we had agreed-on safety stock that helped us through the initial stages of the pandemic. Where we didn’t have the same relationship, we had supply interruptions.”
The same holds true as Thermo Fisher Scientific looks to the challenges ahead. “The worst-case scenario for us is that the market is growing and they need a product – but we don’t have the capacity to supply them,” Abhijeet Kohli says. “The advantage we have working with Novo Nordisk Pharmatech is the assurance of quality, assurance of supply, and the excellent relationship we have in place, so that we’re always able to supply the industry with whatever volume they need.”
For more information regarding Recombinant Human Insulin AF, please contact International Sales Manager Timur Özbay at [email protected]
For many pharmaceutical and biopharmaceutical companies, the coronavirus pandemic has put supply chains to the test, while regulatory requirements are increasingly tightening. Novo Nordisk Pharmatech helps customers reduce their risk, with a high level of consistency in both the quality and supply of our Quats and Human Insulin AF. You can be sure you get the same high quality product, time after time, reliably delivered through local distribution networks. Our comprehensive documentation package and tailored support, which continues through the whole product life cycle, gives you total peace of mind.
(Download the article here)
High quality Quats and Insulin Human AF
Reduce the risk for your raw materials with pharma-grade Quats. We are a specialist and dedicated manufacturer of Quats, for use as both APIs and excipients, in an unequalled, full cGMP grade. Our stringent Quality Management System ensures the right quality products, with a high degree of consistency. We receive excellent ratings in audits from our customers and authorities, including the FDA and EMA, and continue to improve from every audit. Our multi-compendial range of Quats complies to the highest regulatory guidelines, including ICH Q7, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). Some Quats products also follow the Japanese Pharmacopoeia (JP) or the British Pharmacopoeia (BP).
Our high quality Insulin Human AF is manufactured by our parent company, Novo Nordisk, a leading supplier of insulin for over 100 years. With Insulin Human AF, you avoid the risk of impurities such as mycoplasmas, which can pass line to line from the upstream bioreactor and contaminate your whole line. Novo Nordisk manufactures its Insulin Human AF in cGMP facilities, following an ISO 9001 quality system. With very few manufacturing batches a year, the large scale of our manufacturing and our highly standardised processes ensure product consistency. The insulin is analysed according to the current European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP).
Tailored support through the whole product life cycle
Whether you are using insulin as a processing aid or using Benzalkonium Chloride for a highly critical API, we can support you with the level of service and documentation you need. For example, knowing that many of our customers use our Quats as APIs and excipients, we provide a very high level of support for quality control testing. We provide extensive and detailed information about our quality testing methodologies, which are often better than the monograph methodology. This means our customers can replicate our methodologies in their labs and reconfirm that their raw materials are compliant with the certificate of analysis. We can also help our customers decide what testing they need to do for each process, by supporting their risk assessment documentation. For example, ICH Q3D regulations require a defined control strategy for elemental impurities. Our extensive documentation can save our customers the expense of running additional tests.
You have our support for the whole product life cycle and beyond. We keep all records required by authorities to ensure full traceability from manufacturing to delivery. This means that you will continue to have our support towards the end of your product’s shelf life – or even after. We also understand that when you are audited by local authorities, you need a fast response to any questions or requests. We enter into agreements with our customers directly, even if you buy through a distributor, so you can quickly solve any problems. To support this, we have agreements with our distributors and suppliers to ensure traceability across the whole supply chain.
A reliable supplier and a robust supply chain
Your business continuity is our priority. We understand you need a reliable supplier – financially, environmentally and socially – even in times of crisis. As part of Novo Nordisk, we are one of the world’s most financially stable pharma companies. And as all our activities happen within the one company, you also mitigate your risk with fewer players in your supply chain. Our manufacturing and business operations are located in Denmark, which provides very stable political and civil conditions. We assisted the Danish government during the coronavirus crisis, and Novo Nordisk provided rebates to ensure that people around the world still got their insulin. This is an example of our Triple Bottom Line principle: we believe this social investment is also an investment in the long-term profitability of our business.
You can download the article here.
Our cGMP manufacturing facilities make Novo Nordisk Pharmatech the leading supplier of pharmaceutical grade Quats for a wide range of applications. See how we ensure the highest standards of quality, purity and batch-to-batch consistency here at our site in Køge, Denmark.
Controlling for quality, purity and consistency
Being cGMP certified, we ensure that every aspect of our manufacturing process is in control – from our own suppliers to the finished product. From the very beginning, we source the best raw ingredients, which are sampled to check they are in specification. Throughout manufacturing, we monitor the critical parameters for each process, such as temperature or PH level, to make sure the process is in control. When each batch is finished, we perform an analysis tailored to our customers’ requirements to deliver a Certificate of Analysis. Good manufacturing practices are embedded in everything we do, as we strive to keep all our operations completely uniform.
(You can download the article here).
Securing quality is a team effort
Tightly controlled processes require not only the combined efforts of our 70-strong manufacturing team. All of our activities and all of our teams are gathered on one site here at Køge – from Research and Development, to Quality Assurance, Quality Control and even Sales and Marketing. This brings us significant advantages in terms of agility. For example, if we need to take a sample of something in our production
facilities, it’s just a 50m walk to our QC lab. While others might send off their samples and wait days for the results, we can have ours within the hour, stating whether we need to stop and change something or whether we can continue production.
Processes built on knowledge and experience
We have been manufacturing many of our products using the same processes for many years. As a result, our manufacturing teams bring a high level of knowledge and experience to secure the quality of our products. Many know their process so well that they will almost immediately have a hypothesis if they come across an irregularity. Having R&D onsite is also a benefit here. Since they built the process, they know what critical parameters to monitor to help control our processes.
For more information regarding cGMP manufactured Quats products, please contact International Sales Manager Phil Stafford at [email protected]
Novo Nordisk Pharmatech will contribute to the scientific agenda at BioProcess International Digital Week (Dec 7-10) with a presentation on upgrading cell stem cultures.
Theis Guldbech will join Dr. Geraldine Dhiew, Senior Scientist in Esco Aster PTE LTD’s Stem Cell Department, to describe stem cell culture optimization using a combination of Novo Nordisk Pharmatech’s GMP grade TrypsiNNex™ trypsin enzyme, now in final development, and Esco Aster BioNOC™ II macrocarriers.
The webinar will outline the advantages of using TrypsiNNex in 2D and 3D with BioNOC II macrocarriers in cell cultures when compared to available state-of-the-art benchmark proteins, covering cell dissociation, reseeding, cell differentiation and phenotypic markers.
We will also present findings from studies of 3D BioNOC II carriers and tide motion bioreactors for large scale manufacturing of cells.
This work has identified optimal concentrations for 2D and 3D culture detachment and compares this new combination with adipogenic, chondrogenic and osteogenic differentiation for confirming of cell line identity post detachment from 3D carriers by surface marker characterization.
The live webinar series are free to attend. You can sign up here: BioProcessing International Fall Digital Week (informaengage.com)
What is Insulin Human AF and how does it differ from animal-derived insulin? Insulin Human AF, also known as recombinant insulin, consists of human insulin crystals – a biosynthetic product produced by recombinant microbial expression in yeast.
The yeast organism used to produce our recombinant insulin does not contain genes or express antigens of livestock or poultry disease agents. It is neither stored nor grown in media containing animal raw material. This means that our Insulin Human AF supports major growth media suppliers’ definition for an animal-free product.
Our Insulin Human AF is considered to be virologically safe, with a negligible risk of transferring BSE agents to the media or reagents in which our insulin is a component. With our Insulin Human AF, you also avoid the risk of impurities such as mycoplasmas, which can pass line to line from the upstream bioreactor and contaminate your whole line.
Insulin Human AF is a key component in serum-free growth media for mammalian cells. Ideal for manufacturing monoclonal antibodies, virus vaccines, gene therapy products and other biological drug products, it stimulates the proliferation of cells and enhances the yield.
Environmental challenges have never been more critical or more urgent than they are today. Growing consumption, industrialisation and urbanisation threaten not only the sustainability of the environment we live in, but also the health of people around the world. As a global manufacturer and supplier of Quats and Insulin Human, we have both the responsibility and the opportunity to drive change.
At the core of our business is the Triple Bottom Line (TBL) principle: Our social, environmental and financial responsibility inform everything we do and guide every decision we make. Now for the next step in our sustainability journey we have joined Novo Nordisk in its bold environmental strategy, Circular for Zero. Our ambition is Zero environmental impact by 2030.
(You can download the article here).
Adopting a circular mindset
Achieving zero environmental impact will have its challenges, and many questions still need to be answered. We believe the answers will come as we transition our business from a linear mindset of ‘take-make-dispose’ to a circular mindset that keeps our products and materials in use. This is what the Circular for Zero strategy is based on – designing products and packaging that can be recycled or re-used, reshaping our business practice to minimise consumption and eliminate waste, and working with suppliers who share our ambition.
Switching to renewable resources
We have been proudly CO2 neutral since 2018. We are supplied with renewable energy produced by windmills, while our gas consumption comes from biogas certificates. This means that we have zero CO2 emissions from energy consumption. Even some of our grass is mowed by a robotic automower which runs on power from windmills!
Our most recent initiative was creating 10 parking spaces with charging stations for electric vehicles at our headquarters in Køge, Denmark. This has made it even more attractive for our employees to commute in a sustainable way.
Maintaining a sustainable and transparent supply chain
If we want to achieve zero impact, both up and down our supply chain, working with our suppliers is paramount. With both our current and future suppliers, we will collaborate proactively to embed circular thinking across our value chain and switch to circular sourcing and procurement. We also believe in open, trustworthy and timely communications with our neighbours, authorities, customers and suppliers, as well as internally with our employees.
In the interest of a fully accountable supply chain, we are certified according to the ISO 14001/2015 Environmental Management System. Our production was environmentally approved in 2009 by the Danish Ministry of the Environment, which oversees the company’s environmental concerns.