Description

Recombinant Human Insulin

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 you find the right quality ingredients for your projects and supplying you with the appropriate documentation – even tailoring ingredients to match specific application needs.

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.

View our Insulin Brochure

Contact

Timur Özbay
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.

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.

Further Manufacturing Use 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.

Tamper-proof packaging

We pack 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 sufficient dry ice to ensure that the product is kept below the recommend maximum temperature during shipment.

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 Item no. Product image
1g 3068855
10 g 3068856
50 g 3068857
100 g 3068858
1 kg 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

Origin and application

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

Residual Solvents
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.

Solubility
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

Insulin Human AF has a shelf life of 60 months. It must be stored at -20°C ± 5°C 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 connection
with dispensing the product, keeping and handling the product 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.

Shipment boxes

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