Insulin Human AF

Our Insulin Human AF also known as recombinant insulin is a key component in serum free growth media for mammalian cells.

Insulin Human AF

As the leading supplier of recombinant insulin for innovative biologics, Novo Nordisk Pharmatech can help you keep development on track, production flowing and product supplied to hospitals and patients. We remain the best supplier of insulin human or 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.

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We are a reliable partner in helping pharmaceutical companies find the right quality ingredients for their projects and supplying all the appropriate documentation – even tailoring ingredients to match specific application needs. Manufacturing and quality control, precision delivery and a risk mitigation strategy that assures continuous availability are a few of the reasons why you should grow your cells with our insulin. Many of the world’s leading pharmaceutical companies already do.

What is Insulin Human AF?

lnsulin Human AF, also known as recombinant insulin, consists of human insulin crystals, a biosynthetic product produced by recombinant microbial expression in yeast.

Our Insulin Human AF is a key component in serum free growth media for mammalian cells. It is used for the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and other biological drug products approved by regulatory bodies worldwide, including FDA and EMA. Recombinant insulin stimulates the proliferation of cells and enhances the yield.

Our Insulin Human AF is manufactured in cGMP facilities by Novo Nordisk A/S in accordance with Novo Nordisk Pharmatech’s quality system, based on ISO 9001 and cGMP. The product is analyzed according to the current European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP). The Insulin Human AF products are packaged in HDPE bottles and supplied by Novo Nordisk Pharmatech A/S.

For further manufacturing only. Not for therapeutic use.

We guarantee

  • Pure and animal-free recombinant insulin
  • Manufactured at cGMP facility
  • Consistent high quality
  • Full traceability
  • Secure global supply chain
  • Extensive regulatory documentation
  • Continuous availability
  • High levels of service and support
  • Cost-effective customised solutions
  • Narrower specification than pharmacopoeia requirements
  • Manufacturing facilities inspected by FDA
  • Safety stock at multiple secured locations
  • Large-scale bulk batches solely for the cell growth market
  • Five-year shelf life
  • Robust risk mitigation strategy
  • Certified Known Consignor supplier

Precision delivery

Novo Nordisk Pharmatech can assure you of dependable availability and a continuous supply of products for your cell culture media applications. We have sufficient packed off-the-shelf recombinant insulin in stock for at least five months of consumption, enabling us to respond immediately to your specific requirements. Our two locally placed distribution centers – near Copenhagen, Denmark, and in Indiana, USA – ensure short lead-times and precision delivery worldwide.

Risk mitigation

Our manufacturing facilities are carefully placed to ensure the most secure geographic, weather, political and civil conditions. They have strong, long-standing relations with suppliers and meet the highest standards of fire and explosion risk prevention. Due to our risk mitigation strategy, we are able to rapidly and efficiently manage and counteract threats to your product supply.

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50 g
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100 g
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Documentation and services

  • ISO 9001 Certificate
  • Certificate of Analysis (current version of pharmacopoeias)
  • Customer audits
  • Declarations, statements (TSE/BSE, allergens, etc.)
  • Change Notification Statement
  • Pre-filled Supplier Questionnaire
  • Packaging details

Handling and Storage

Insulin Human AF has a shelf life of 60 months. It must be stored at -20°C ± 5°C to avoid potential degradation and to ensure compliance with the product specification for the entire shelf life period.

Insulin Human AF can be stored at refrigerator temperature (+2 to +8°C) for up to 14 days in total, accumulated over its shelf life period. Within the shelf life period, the product should not be thawed/re-frozen more than five times. In connection with dispensing the product, keeping and handling the product at up to 25°C is allowed for up to 24 hours.

Packaging materials and shipment

The product is dispensed into a range of HDPE plastic containers as illustrated to the left. The containers are cleaned in an automated washing machine prior to filling the product. The primary plastic containers are placed in individual, tamper-proof plastic bags.

The tamper proofed containers are placed in approved thermo containers, inside a cardboard box and packed with sufficient dry ice to ensure that the product is kept below the recommend maximum temperature during shipment, as shown in the photo above.

Depending on the volume of the primary plastic containers, either a small or large shipment box is used – both boxes are validated to meet the requirements listed below.

Small shipment box

  • Product kept below max. temperature (-15°C) for 6 days (144 hours)
  • 38 kg dry ice included
  • Max. volume 6 x 250 ml primary plastic containers
  • Exterior measurements (approx.) 605x510x440mm

Large shipment box

  • Product kept below max. temperature (-15°C) for 7 days (168 hours)
  • 63 kg dry ice included
  • Max. volume 5 x 5 L primary plastic containers
  • Exterior measurements (approx.) 800x600x805mm

Origin and application

Application

Insulin is a key component in serum-free growth media for mammalian cells, used for the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and other biological drugs. It stimulates the proliferation of cells.

Origin of Recombinant Insulin

The yeast organism used to produce our recombinant insulin does not contain genes or express antigens of livestock or poultry disease agents, and is neither stored nor grown in media containing animal raw material. It is considered to be virologically safe, and the risk of transferring BSE agents to the media or reagents in which Novo Nordisk Human Insulin is a component is negligible, since:

  • No animal component is used in the manufacturing process
  • A recombinant enzyme is used in the process
  • The production strain for manufacture is yeast, which is not the natural host for mammalian viruses

Fully animal free

Our recombinant insulin supports major growth media suppliers’ definition for an animal free product. No animal origin component is used in the cell bank and manufacturing process. The yeast organism used for production does not contain genes nor express antigens of livestock or disease agents. The trypsin is replaced by a proprietary process aid of non-animal origin. Additionally, our insulin is antibiotic free, both in terms of production facilities and on a cell bank level.

Residual Solvents

Insulin Human AF complies with ICH Q3C Note for Guidance on residual solvents. The solvents used are added earlier in the process and are removed during the following process steps, and the residual solvent levels comply with the limits established in ICH Q3C.

Solubility

Insulin is a small (5,8 kDa) hydrophobic molecule and is easily dissolved in a buffer at relatively low pH, compared to the pI value of insulin (pI = iso electric point). At neutral pH, it will take longer to dissolve. The pI of the Insulin molecule is 5,8.

Therefore it can be seen that when dissolving the Insulin at low pH and adding it to a media at neutral pH (around pH 7,5), it precipitates for a short moment, due to the fact that pH is passing the pI value of Insulin.

It is recommended to add dissolved insulin to the media while stirring. Instructions for dilution of Insulin Human AF can be provided upon request to Novo Nordisk Pharmatech.

Application for Insulin Human AF

Recombinant insulin for innovative biologics

Our recombinant insulin is a key component in serum free growth media for mammalian cells.

It is used many cell lines, such as CHO-s, HEK 293 or Sf9, for the manufacturing of:

  • Monoclonal antibodies
  • Virus vaccines
  • 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 90 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.

CHO-s

Increase viable CHO cell density by supplementation with recombinant Insulin Human AF.

CHO cells are one of the most widely used platforms for the production of 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 in collaboration with Novo Nordisk Pharmatech (world’s largest supplier of recombinant insulin) has shown that addition of animal origin free insulin to three leading commercially available off-the-shelf chemically defined media under batch-mode culture resulted in significant increases in viable cell density, leading up to 53 % cell growth improvement and 66% of targeted protein production.

In addition to this benefit insulin has been proven to aid in the expression of difficult to express proteins.

You can read or download the poster here. In case of questions to the text above, please contact us.

HEK293

Increase specific influenza production with recombinant insulin.

Mammalian cells are considered an alternative to eggs for the production of influenza vaccines. HEK293SF-3F6 is a suspension GMP cell line that grows in serum-free media, and influenza production has been achieved in flasks and large bioreactors.

National Research Council Canada (NRC) in collaboration with Novo Nordisk Pharmatech (world’s largest supplier of recombinant insulin) has shown that addition of animal origin free insulin to commercial available media and in-house proprietary media in HEK 293SF-3F6 batch-mode culture, resulted in significant increases in cell growth, leading up to 4-fold increase compared to insulin free media formulations.

In addition to cell growth, the study aimed to address the effect of Insulin on HEK-based Influenza Production, since the effect on Influenza virus productivity was not known.

Insulin has been proved already to positively affect cell survival, by promoting anti-apoptotic and mitogenic pathways, to interact on cellular signalling pathways that are exploited by the influenza virus and it has the benefit of being already approved by regulatory agencies.

This study has shown that addition of animal origin free insulin to commercial available media and in-house proprietary media in HEK 293SF-3F6 micro-bioreactor culture, resulted in significant increase in H1N1 and H3N2 Influenza subtypes , leading to up to 1,9-fold increase compared to insulin free media formulations.

You can read or download the poster here. In case of questions to the text above, please contact us.

Sf9 insect cells

Increase viable Sf9 cell density and Baculovirus-based VLP production by supplementation with recombinant Insulin Human AF.

Sf9 insect cells are the most widely used platforms during the manufacturing process of recombinant protein therapeutics when a fast and flexible system is needed.

The baculoviral-insect cell system has shown to be a powerful alternative for the production of recombinant proteins in short time frames.

As for the CHO cell-based manufacturing process, increased demand for safety and reliability has moved the standard for Insect cell culture media from Serum to Serum free and further on to chemically defined media.

UAB in collaboration with Novo Nordisk Pharmatech (world’s largest supplier of recombinant insulin) has shown a significant increase in viable cell density and baculovirus-dependent VLP production with the addition of animal origin free Insulin into commercially available chemically defined media in Sf9 batch-mode culture, leading up to 1,2-fold increase in VLP particles.

You can read or download the poster here. In case of questions to the text above, please contact us.

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Why Human Insulin AF?

Highest standards

Our Insulin Human AF also known as recombinant insulin is sourced directly from Novo Nordisk, the world’s largest producer. With more than 90 years of experience with Insulin, Novo Nordisk ensures the most stable and well-established manufacturing processes and specialist know-how on the market.

The insulin human is manufactured under ISO 9001 Quality Systems and cGMP compliance and fulfils all relevant European and US guidelines and pharmacopoeia.

Novo Nordisk Pharmatech was established in 1949 and acquired by Novo Nordisk in 1986. We have a long track record of reliability, stability and financial security. We live up to the highest quality standards, with a quality management system complying with DS/EN ISO 9001 for all activities.

Consistency and High Purity

We specialize in supplying ingredients to the biopharmaceutical and pharmaceutical industries and we deliver as promised, on-spec and on time.

Our Insulin Human AF is manufactured in large-scale bulk batches solely for the cell growth market and has a five-year shelf-life. We pack in our own classified room facility and the containers are tamper proof.

We guarantee:

  • Pure and animal-free recombinant insulin
  • Consistent high purity and quality between batches
  • Narrower specifications than the current pharmacopoeia requirements

66% yield increase in CHO Cells

CHO cells are one of the most widely used platforms for the production of 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.

Addition of animal origin free insulin to chemically defined media under batch-mode culture has proven significant increases in viable cell density, leading up to 53 % cell growth improvement and 66% of targeted protein production.

MAB production

60% yield increase in HEK Cells

HEK293 Serum Free cells are used as an alternative to eggs for the production of influenza vaccines, in suspension and adherent mode.

Insulin positively affects cell survival, by promoting anti-apoptotic and mitogenic pathways, to interact on cellular signalling pathways that are exploited by the influenza virus. It also has the benefit of being already approved by regulatory agencies. Addition of animal origin free insulin to commercial available media and in-house proprietary media in HEK 293 cells, resulted in significant increases in cell growth, leading up to 4-fold increase and in 60% yield increase in H1N1 and H3N2 Influenza subtypes.

Serum-free medium

20% yield increase in SF9 cells

Sf9 insect cells are the most widely used platforms during the manufacturing process of recombinant protein therapeutics when a fast and flexible system is needed. Increased demand for safety and reliability has moved the standard for Insect cell culture media from Serum to Serum free and further on to chemically defined media.

Addition of animal origin free insulin into commercially available chemically defined media significantly increases viable cell density and baculovirus-dependent VLP production leading up to 20% yield increase.

VLP production in SF9 cells

Secure global supply chain

Every successful product needs a secure supply chain. Novo Nordisk Pharmatech A/S can help by ensuring dependable availability and a continuous supply of products.

You can rely on our robust risk mitigation strategy:

  • Our entire manufacturing and quality control take place in Denmark, and our supply chain is limited within Scandinavia.
  • Our manufacturing facilities are carefully placed to ensure the most secure geographic, weather, political and civil conditions.
  • We maintain safety stocks at multiple secure locations.
  • We have full traceability of the entire supply chain.

Global regulatory compliance

Our manufacturing facilities are inspected by the US FDA, and both Novo Nordisk and Novo Nordisk Pharmatech are regularly audited by major and minor pharmaceutical companies and inspected by the Danish Medicine Agency.

Our comprehensive documentation and services include:

  • ISO 9001 certificate
  • Certificate of Analysis (current versions of Ph.Eur. and USP/NF pharmacopoeias)
  • Customer audits
  • Declarations, statements (stability, residual solvents, TSE/BSE, GMO, allergens, environment, etc.)
  • Change Notification
  • Answering of questionnaires
  • Process flowchart
  • Packaging details
  • Quality assurance agreements

Embracing a circular mindset

Our new environmental strategy, Circular for Zero, sets out targets and milestones for the next 10 years of this journey. Our ambition is bold and simple: to have zero environmental impact.

We will collaborate proactively with suppliers to embed a circular mindset for reduced environmental impact across our value chain and switch towards circular sourcing and procurement.

We will eliminate the environmental footprint from our operations and drive a circular transition across the company to achieve our zero environmental impact ambition.

We will upgrade existing and design new products based on circular principles and solve the end-of-life product waste challenge to close the resource loop.

Click here to read more about our environmental work.

Sustainability and triple bottom line

Novo Nordisk is a member of the UN Global Compact and World Business Council for Sustainable Development (WBSCD). As a fully owned subsidiary, we follow the general policies of Novo Nordisk for sustainability, business ethics and code of conduct.

We believe that a healthy economy, environment and society are fundamental to long-term business success. This is why we manage our business in accordance with the Triple Bottom Line (TBL) business principle, conducting activities in a financially, environmentally and socially responsible way.

Read more about our work within Environment, Health and Safety here.

Preferred supplier

Our highly qualified personal work continuously on product development and improving documentation, to suit your needs and the ever-increasing global regulatory requirements.

Working with us is a great asset to minimize risk, as part of your risk
management strategy.

Our expertise – together with product and documentation availability and global compliance – has made Novo Nordisk Pharmatech a preferred supplier to leading biopharmaceutical companies worldwide.

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Tina Rydahl Pedersen
Customer Support Assistant

Phone: +45 3199 5922
Email: nnprinfo@novonordisk.com

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