Insulin Human AF

Our Insulin Human AF is a key component in serum free growth media for mammalian cells.

Description

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 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.

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.

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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 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.

Packing Sizes
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Packing Sizes
1g
Item no.
3068855
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3068855
Packing Sizes
10 g
Item no.
3068856
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3068856
Packing Sizes
50 g
Item no.
3068857
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3068857
Packing Sizes
100 g
Item no.
3068858
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3068858
Packing Sizes
1 kg
Item no.
3068859
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3068859

Documentation and services

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

Phone: +45 3199 5922
Email: [email protected]

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