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

Recombinant Human Insulin AF

What is Insulin Human AF, recombinant insulin?

Insulin Human AF is a recombinant protein, consisting of human insulin crystals, a biosynthetic product expressed by recombinant microbial expression in yeast. As insulin binds to its receptor, it initiates different intracellular signalling pathways involved in regulating cell growth, cell differentiation, cell survival, and cellular glucose uptake. Insulin promotes cell culture growth and enhances protein yields by modulating transcription, DNA synthesis and replication, and stimulating protein translocation.

Insulin Human AF is used by biopharmaceutical companies worldwide to produce monoclonal antibodies, virus vaccines, gene therapy drugs, and other innovative biologic products approved by regulatory bodies worldwide, including FDA and EMA.

For further manufacturing only. Not for therapeutic use.

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Applications for recombinant insulin

Insulin Human AF is a key component in serum free growth media for mammalian cells. It is used as supplement in the cell culture media for several cell lines, such as CHO, HEK293 or Sf9, for the manufacturing of monoclonal antibodies, virus vaccines, or gene therapy products.

Insulin increases mAbs yields in CHO cells

Important proteins in the development of oncology treatments, monoclonal antibodies (mAbs) are most often produced in CHO cells. Data show supplementing Insulin Human AF to the cell culture media leads to an increase in the yield of mAb production of up to 66%.

MAB production graph

 

Find the full details of the study here.

Insulin enhances AAV and LV viral vectors production

In the growing gene therapy and viral vector industries, recombinant insulin is helping manufacturers to scale-up production, optimise processes, and increase cellular products yields. Data show that supplementing insulin to HEK293 cell cultures leads to a 68% increase in titres of adeno-associated virus serotypes 2, 5, and 8 (AAV2, AAV5, AAV8). For lentivirus (LV), the increase in virus titer observed following insulin supplementation corresponds to the 120% (figure).

AAV and LV viral vectors

Lentivirus

 

Find the full details of the study here.

Insulin increases Influenza Virus production in HEK293 cells

One of the major challenges of the viral vaccine industry is to produce large quantities of vaccines in a fast, cost-effective way. Supplementing insulin to chemically defined media for the cell culture of influenza virus-producing HEK293 cells results in a 4-fold cell growth increase and a 60% virus production increase.

Serum-free medium graph

Find the full details of the study here.

Other studies using recombinant insulin are available here.

Insulin Human AF – enabling better medicines

Enabling better medicines_Insulin

10 reasons to choose Insulin Human AF

Recombinant Insulin is sourced directly from Novo Nordisk, the world’s largest producer of Insulin. 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. By providing excellence at every step of the supply chain, Novo Nordisk Pharmatech is the market leading supplier of insulin for cell culture processes

Download the 10 reasons why Insulin Human AF brochure here.

We guarantee

We live up to the highest quality standards, with a quality management system complying with DS/EN ISO 9001 for all activities. Insulin Human AF is sourced directly from our mother company Novo Nordisk, the world’s largest producer of Insulin. Insulin is manufactured under ISO 9001 Quality Systems and cGMP compliance and fulfils all relevant European and US guidelines and pharmacopoeia. Our manufacturing facilities are inspected by the US FDA, and both Novo Nordisk and Novo Nordisk Pharmatech are regularly audited by pharmaceutical companies and inspected by the Danish Medicine Agency.

Insulin Human AF is produced in yeast. This organism is neither stored nor grown in animal-containing media and does not contain genes or express antigens of livestock or poultry disease agents. Our recombinant insulin meets major cell culture media suppliers’ requirement for animal-free products. No animal origin component is used in the cell bank and manufacturing process. The trypsin used during insulin manufacture is replaced by a proprietary process aid of non-animal origin. Additionally, our insulin is antibiotic free. Insulin Human AF complies with ICH Q3C Note for Guidance on residual solvents.

Our recombinant insulin is manufactured in large-scale bulk batches, solely as supplement for cell culture media. Recombinant insulin complies with ICHQ1 guidelines for stability testing for new drug products. Different batches of recombinant insulin show consistent batch-to-batch quality.

Recombinant insulin

With 100 years of experience with Insulin in 2023, Novo Nordisk ensures the most stable and well-established manufacturing processes and specialist know-how on the market. We are specialized in supplying ingredients to the biopharmaceutical and pharmaceutical industries and we deliver as promised, on-spec and on time. Our recombinant Insulin is used by global large biopharmaceutical companies for the manufacture of their blockbuster drugs.

Insulin is a key component in serum-free growth media for mammalian cells, as it stimulates the proliferation of cells. Recombinant insulin is used as supplement in the culture media for many cell lines, such as CHO, HEK 293 or Sf9, for the manufacturing of monoclonal antibodies, virus vaccines, or gene therapy products, for example. Recombinant insulin can also be used to produce other biological drug products approved by regulatory bodies worldwide, including FDA and EMA.

Discover the benefits of adding recombinant insulin to cell culture media:

Insulin increases mAbs yields in CHO cells

Insulin enhances AAV and LV viral vectors production (link to the poster or insulin insights)

Insulin increases Influenza Virus production in HEK293 cells

Insulin improves HIV VLP production in insect Sf9 cells

We offer a comprehensive list of documentation and services:

  • 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, etc.)
  • Change Notification
  • Pre-filled Supplier Questionnaire
  • Process flowchart
  • Packaging details
  • Quality assurance agreements
  • Certification as known consignor supplier

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. Our customers 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.

Recombinant Insulin has a shelf life of 5 years. The product is dispensed into a range of HDPE plastic container, 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 recommended maximum temperature during shipment. Depending on the volume of the primary plastic containers, either a small or large shipment box is used.

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 605x510x440mm approximately

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 800x600x805mm approximately

Relying on Novo Nordisk’s 100 years of experience within the biopharmaceutical industry in 2023, our customers can have access to many in-house specialists who can offer their technical support, even from early product development stages. According to their needs, our customers can find a broad range of cost-effective customised solutions. Our dedicated customer support team is ready to assist with all types of requests, including documentations and shipping requests.

The target of our environmental strategy for the next 10 years of this journey is to have zero environmental impact by 2030. We 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 aim to eliminate the environmental footprint from our operations and drive a circular transition across the company.

A guide to using recombinant insulin to enhance cell culture growth

Produced naturally by the body, growth factors function to regulate cell division and cell survival in vivo. They can be biosynthetically produced and have a strong history of use in the pharmaceutical industry, where they help manufacturers to optimise yields of biologic drug products. A prime example is insulin – a key component in serum-free growth media for mammalian cells.

Insulin is part of a family of growth factors, including Insulin-Like Growth Factors IGF 1 and IGF 2. Novo Nordisk Pharmatech’s Insulin Human AF is a recombinant insulin product used by biopharmaceutical companies worldwide in the production of monoclonal antibodies, virus vaccines, and gene therapy drugs, plus a range of other innovative biologic products.

As insulin binds to a receptor, it initiates different intracellular signalling pathways involved in regulating cell growth, cell differentiation, cell survival, and cellular glucose uptake. By modulating transcription, DNA synthesis, and replication, and stimulating protein translocation, insulin promotes cell culture growth and enhances yields.

Insulin Human AF is best-used in serum-free (chemically defined) media. Let’s take a look at some examples.

What do the studies say?

Important proteins in the development of oncology treatments, monoclonal antibodies (mAbs) are most often produced in CHO cells. With the application of Insulin Human AF, data has shown up to a 66% yield increase in mAb production, alongside increases in cell viability and density.

In the growing gene therapy and viral vector industries, recombinant insulin is helping manufacturers scale-up production, optimise processes, and increase yields. Looking at the influence of insulin on viral vectors for adeno-associated virus serotypes 2, 5, and 8 expressed in HEK 293 cells, Novo Nordisk Pharmatech has observed up to a 68% increase in titres compared to the control. For lentivirus, up to 120% increase in yields was noted.

The viral vaccine industry is also under pressure to produce large quantities of vaccines in a fast, cost-effective way. In a study using HEK 293 cells for influenza vaccines, it has been observed that adding recombinant insulin to chemically defined media can produce up to a four-fold cell growth increase and a 60% yield increase.

The full details of these studies and other application notes are available on demand from Novo Nordisk Pharmatech. There is a body of evidence supporting the use of this growth factor for the proliferation of mammalian cells, but what do you need to consider when working with insulin?

What you should know

If using commercially available media, it is important to know the full contents of the media, including whether insulin is already contained. Using this information, manufacturers will most likely need to optimise the media to their own cell line and the desired end-product. This can involve optimising the insulin level by doing trials at different concentrations. Based on our own published data, Novo Nordisk Pharmatech is happy to guide customers on which insulin concentrations will produce the highest yields for their desired cell line.

If you decide recombinant insulin is the right growth factor for your cell culture, the next step is to ensure you source it from a reliable, fully qualified supplier. It is also important to use ingredients with a high batch-to-batch consistency, helping you keep better control of your processes. Insulin Human AF is manufactured by our parent company, Novo Nordisk, and supplied to patients around the world for therapeutic use. Manufactured in cGMP facilities and following an ISO 9001 quality system, the product is produced in accordance with the highest requirements on the market.

Insulin Human AF comes in a dry crystalline form, which can be dissolved in water. It has a long shelf life of five years but must be stored and handled carefully across this time. To ensure Insulin Human AF stays within product specifications, it should be stored at freezing temperature, below -20°C. However, the product can tolerate being held in refrigerator or room temperature for limited periods of time.

Sara Bursomanno
Sara Bursomanno
Product Manager

Phone: +45 31970096
Email: usbu@novonordisk.com

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