August 15, 2014
Danish-based FeF Chemicals is a preferred specialist supplier of premium quality ingredients for the biopharmaceutical and pharmaceutical industries across two unique product areas: insulin human AF for cell culture media and current good manufacturing practice (CGMP)-manufactured quaternary ammonium compounds (QUATS). And although high quality, innovation, flexibility, and security of supply are among its market-leading features, end-user patients are the motivators. FeF Chemicals supplies insulin human AF (for use in cell culture media) from Novo Nordisk, the largest insulin manufacturer worldwide.
Strong Historic Foundation:
The company was first established in 1949. It was acquired by Novo Nordisk in 1986 and has been part of the pharmaceutical group since then. Novo Nordisk is a renowned global leader with over 90 years of innovation and leadership in diabetes care. The group’s core values are centered on improving the lives of patients. It also strives for excellence, is accountable to customers and stakeholders, and is at the forefront of innovation.
Quality Standards and External Audits:
Our insulin human AF product fulfills the definition of an animal-free product. It is manufactured under CGMP operations and complies with ICH Q7 and ISO 9001. Insulin human AF is in compliance with the European Pharmacopoeia (PhEur) and with United States Pharmacopeia (USP) and exceeds the specification on several tests (Table 1). FeF Chemicals and Novo Nordisk are regularly audited by minor and major pharmaceutical companies.
TABLE 1: Our insulin Human AF exceeds the PhEur and USP pharmacopoeias specifications on the following tests
Our insulin Human AF exceeds the PhEur and USP pharmacopoeias specifications on the following tests
Application:
Insulin human AF is used to manufacture several biopharmaceutical drug products approved by regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency. Insulin is a key component in serum-free growth media for mammalian cells, used to manufacture monoclonal antibodies, virus vaccines, gene therapy products, and other biological drugs. It stimulates the proliferation of cells. Insulin human is for further manufacturing use only and not for therapeutic use.
Security of Supply:
A key to our success at FeF is the stability and capability that guarantees our customers most fundamental requirement; security of supply. To ensure availability and a continuous supply of products for cell culture media applications, FeF Chemicals and Novo Nordisk have implemented and continues to maintain a number of initiatives to mitigate supply risks, including
several manufacturing sites
safety stock at multiple secured locations
large-scale bulk batches manufactured solely for the cell growth market, of the same high quality as insulin used in the human drug product
five years shelf life
multiton-scale production and capacity
robust risk-mitigation strategy to secure supply safety
certified known consignor supplier
distribution from Denmark and the United States.
This gives our customers a reassuring feeling that our business relationship is and will continue to be long standing.
Jeannette Westergaard is product manager at FeF Chemicals; 45-30370079;
[email protected].
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