Recombinant Insulin Human

Novo Nordisk Pharmatech supplies recombinant insulin for cell culture processes by providing excellence at every step of the supply chain.

The company is a reliable partner in helping pharmaceutical companies find the right quality ingredients for their projects and supplying all the appropriate documentation. It also tailors 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 many of the world’s leading pharmaceutical companies grow cells with Novo Nordisk Pharmatech’s insulin.

Packaging sizes:

  • Item number: 3068855, 1g
  • Item number: 3068856, 10g
  • Item number: 3068857, 50g
  • Item number: 3068858, 100g
  • Item number: 3068859, 1kg

What is Insulin Human AF?

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

Insulin is essential for long-term growth of commonly used mammalian cell lines for cell culture media.

Insulin Human AF is manufactured in accordance with Novo Nordisk Pharmatech’s quality system, which is based on ISO 9001 and current good manufacturing practices (cGMP). It is also analysed according to the current European Pharmacopoeia and US Pharmacopoeia (USP).

The product is manufactured in cGMP facilities by Novo Nordisk A/S and packaged in high-density polyethylene (HDPE) bottles and supplied Novo Nordisk Pharmatech A/S.

Documentation and services

Novo Nordisk Pharmatech provides a range of documentation, including:

  • ISO 9001 Certificate
  • Certificate of Analysis (current version of Pharmacopoeias)
  • Customer audits
  • Declarations and statements such as transmissible spongiform encephalopathy (TSE) / bovine spongiform encephalopathy (BSE) statements, residual solvents, genetically modified organism (GMO), allergens and animal testing
  • Change notification statement
  • Pre-filled supplier questionnaire
  • Packaging details

Origin and application

Insulin is a key component in serum-free growth media for mammalian cells and is 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 Novo Nordisk Pharmatech’s recombinant insulin does not contain genes or express antigens of livestock or poultry disease agents, and is neither stored or grown in media containing animal raw material.

It is considered to be virologically safe and there is negligable risk of transferring BSE agents to the media or reagents, as:

  • 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

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. Any residual solvent levels comply with the limits established in ICH Q3C.

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