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AF Insulin for pharmaceutical applications from Novo Nordisk Pharmatech
Innovative Danish ingredient manufacturer Novo Nordisk Pharmatech is a leading global supplier of recombinant animal-free (AF) human insulin that is vital for the optimization of biopharma processes.
Novo Nordisk Pharmatech’s success resides with its high purity recombinant insulin to optimize cell growth, density and viability in serum free and chemically-defined growth media, further increasing its value as a key component in innovative biologics and pharmaceutical grade products.
Recombinant Human Insulin
lnsulin Human AF, also known as recombinant insulin, consists of human insulin crystals, a biosynthetic product produced by recombinant microbial expression in yeast.
AF Human Insulin is a key component in serum free growth media for mammalian cells, stimulating the proliferation of cells and enhancing yields. It is therefore vital to the manufacturing of monoclonal antibodies, virus vaccines, gene therapy products and other biological drug products approved by regulatory bodies worldwide, including FDA and EMA.
Human insulin production
Novo Nordisk Pharmatech secures human insulin global supplies with rigorous attention to detail and commitment to excellence at every stage of the value chain.
This begins with the quality of its insulin, which is sourced directly from parent company Novo Nordisk, the world’s largest producer.
Novo Nordisk manufactures recombinant insulin in its own cGMP facilities with Insulin Human AF production based on a yeast organism that 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. This makes it virologically safe, with negligible risk of transferring BSE agents to associated media or reagents.
Production standards are guided by the Novo Nordisk Pharmatech quality system, which is based on ISO 9001 and cGMP guidelines and analyzed to ensure it exceeds the standards required by current European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP).
Security of supply
Novo Nordisk Pharmatech backs up its recombinant insulin offers with all the support needed to keep development on track, production flowing and product supplied to hospitals and patients. This includes comprehensive documentation and all the evidence needed to satisfy regulators, along with cGMP manufacturing and quality control, precision delivery and risk mitigation strategies to assure continuous availability.
Recombinant AF insulin is packed in Novo Nordisk Pharmatech’s own classified room facilities with primary packaging in sterile HDPE plastic containers, which are placed in individual tamper-proof plastic bags, then placed in approved thermo containers, inside a cardboard box and shipped in dry ice to ensure product is kept below the recommend maximum temperature during shipment.
Novo Nordisk Pharmatech can also tailor recombinant insulin ingredients to match specific application needs.
It is also able to guarantee full traceability, a secure global supply chain, safety stock at multiple secured locations, large-scale bulk batches solely for the cell growth market, minimum five-year shelf life and is certified as a Known Consignor.