FAQ

Our high quality Insulin Human AF

Insulin Human AF, also known as recombinant insulin, consists of human insulin crystals, a biosynthetic white powder produced by a recombinant microbial expression in yeast with a synthetic gene insert.

Our Insulin Human AF 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 or 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.

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. Insulin Human AF stimulates the proliferation of cells and enhances the yield.

Our Insulin Human AF is manufactured by our parent company, Novo Nordisk, a leading supplier of insulin for over 100 years. This is the same high quality insulin that is supplied to patients all around the world for therapeutic use. The Insulin Human AF is manufactured in cGMP facilities, following an ISO 9001 quality system. 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). Both Novo Nordisk and Novo Nordisk Pharmatech are regularly audited by major and minor pharmaceutical companies, as well as health authorities.

We provide a simple, ‘one-stop’ solution to regulatory compliance, providing you with everything you need in a fast and convenient way. You have our full support for your questions and requests well after supplier qualification and delivery, and throughout your whole product life cycle. Tailored to the level of service you need,
our comprehensive documentation and support package includes:

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

Available in packing sizes from 1g to 1kg, our Insulin Human AF is filled in our own classified room facilities. The product is dispensed into a range of HDPE plastic containers, which 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 dry ice to ensure that the product is kept below the recommended maximum temperature during shipment.

We have enough packed off-the-shelf Insulin Human AF in stock for at least five months of consumption, enabling us to respond immediately to your specific requirements. Our Insulin Human AF has a five-year shelf life. Our two locally placed distribution centres – near Copenhagen, Denmark, and in Indiana, USA – ensure short lead-times and precision delivery worldwide. We are a certified Known Consignor supplier.

We recommend a titration of various insulin concentrations (0mg/L, 1 mg/L, 2mg/L 5mg/L, 10mg/L, 20mg/L) with your cell line and medium in a small batch culture to find the optimal insulin concentration for your conditions. You can then evaluate if insulin addition during cell growth (e.g. day 0, day 3, day 6) further improves growth, viability or productivity.

To dissolve the powder:

  1. Suspend the insulin product in WFI or purified water.
  2. Dissolve the insulin product by adjusting the pH to 3 with diluted HCl (0.1 or 0.01M, depending on the desired volume of growth medium). The insulin solution should not be held at pH 3 for more than one hour.
  3. Readjust the pH to 7.4 with buffer or base. The solution becomes cloudy when passing through the isoelectric point of the insulin product, but becomes clear again as the pH of the solution reaches 7.
  4. The solution should be sterile filtered using a low protein binding filter with a pore size of 0.2 μm. Avoid aeration and foaming during solubilisation and filtration, as this can lead to protein denaturation.

The recommended concentration of Insulin Human in cell culture media is 1 – 10 mg/L, depending on cell type and specific application.

Store the Insulin Human AF at -20°C +/-5°C in its original container, avoiding humidity and sunlight, 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 order to dispense the product for use, handling and storage at up to 25°C is allowed for up to 24 hours. The dispensed product should be kept at +2 to +8°C until use.

These recommendations and limitations apply from the time of shipment from Novo Nordisk Pharmatech and refer to the original primary packaging container.

Our Insulin Human AF has a shelf life of 5 years from the date of manufacturing.

For more information about our Insulin products, please contact us or click here.

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