Recombinant lnsulin Human
Recombinant Human Insulin
We remain the leading supplier of Recombinant Insulin for cell culture processes by providing excellence at every step of the supply chain – beginning with the quality of our Recombinant Insulin Human, 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 many of the world’s leading pharmaceutical companies grow cells with our insulin.
International Sales Manager for US and Europe
Phone: +45 2429 4166
Email: [email protected]
What is lnsulin 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.
lnsulin is essential for long-term growth of commonly used mammalian cell lines for the cell culture media.
Manufactured in accordance with Novo Nordisk Pharmatech’s quality system, based on ISO 9001 and cGMP.
Analyzed according to the current European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP).
The product is manufactured in cGMP facilities by Novo Nordisk A/S and packaged in HDPE bottles and supplied Novo Nordisk Pharmatech A/S.
Further Manufacturing Use Only. Not for Therapeutic Use.
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Documentation and services
ISO 9001 Certificate
Certificate of Analysis (current version of pharmacopoeias)
Declarations, statements (TSE/BSE, GMO, allergens, etc.)
Change Notification Statement
Pre-filled Supplier Questionnaire
Origin and application
lnsulin 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 lnsulin
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
lnsulin 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.
lnsulin 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 lnsulin molecule is 5,8.
Therefore it can be seen that when dissolving the lnsulin 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 lnsulin.
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.
Handling and storage
Handling and storage at refrigerator and room temperature. The product is assigned a shelf life of 60 months.
Recombinant lnsulin Human AF must be stored at -20°C ± 5°C to avoid any potential degradation and to ensure compliance with the specification for the entire shelf life period.
It 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 5 times.
In connection with dispensing the product, keeping and handling Insulin Human AF 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