Recombinant Insulin

Our Recombinant Insulin, also known as Insulin Human AF, is sourced directly from Novo Nordisk, the world’s largest producer. With more than 90 years of experience with Insulin, Novo Nordisk ensures the most stable and well-established manufacturing processes and specialist know-how on the market.

The insulin is manufactured under ISO 9001 Quality Systems and cGMP compliance and fulfils all relevant European and US guidelines and pharmacopoeia.

Novo Nordisk Pharmatech was established in 1949 and acquired by Novo Nordisk in 1986. We have a long track record of reliability, stability and financial security. We live up to the highest quality standards, with a quality management system complying with DS/EN ISO 9001 for all activities.

We specialize in supplying ingredients to the biopharmaceutical and pharmaceutical industries and we deliver as promised, on-spec and on time.

Our Recombinant Insulin is manufactured in large-scale bulk batches solely for the cell growth market and has a five-year shelf-life. We pack in our own classified room facility and the containers are tamper proof.

We guarantee:

• Pure and animal-free recombinant insulin
• Consistent high purity and quality between batches
• Narrower specifications than the current pharmacopoeia requirements

CHO cells are one of the most widely used platforms for the production of biopharmaceuticals. Increased demand for safety and reliability has moved the standard for CHO cell culture media from Serum to Serum free and further on to chemically defined media.

Addition of animal origin free insulin to chemically defined media under batch-mode culture has proven significant increases in viable cell density, leading up to 53 % cell growth improvement and 66% of targeted protein production.

HEK293 Serum Free cells are used as an alternative to eggs for the production of influenza vaccines, in suspension and adherent mode.

Insulin positively affects cell survival, by promoting anti-apoptotic and mitogenic pathways, to interact on cellular signalling pathways that are exploited by the influenza virus. It also has the benefit of being already approved by regulatory agencies. Addition of animal origin free insulin to commercial available media and in-house proprietary media in HEK 293 cells, resulted in significant increases in cell growth, leading up to 4-fold increase and in 60% yield increase in H1N1 and H3N2 Influenza subtypes.

Sf9 insect cells are the most widely used platforms during the manufacturing process of recombinant protein therapeutics when a fast and flexible system is needed. Increased demand for safety and reliability has moved the standard for Insect cell culture media from Serum to Serum free and further on to chemically defined media.

Addition of animal origin free insulin into commercially available chemically defined media significantly increases viable cell density and baculovirus-dependent VLP production leading up to 20% yield increase.

Every successful product needs a secure supply chain. Novo Nordisk Pharmatech A/S can help by ensuring dependable availability and a continuous supply of products.

You can rely on our robust risk mitigation strategy:

• Our entire manufacturing and quality control take place in Denmark, and our supply chain is limited within Scandinavia.
• Our manufacturing facilities are carefully placed to ensure the most secure geographic, weather, political and civil conditions.
• We maintain safety stocks at multiple secure locations.
• We have full traceability of the entire supply chain.

Our manufacturing facilities are inspected by the US FDA, and both Novo Nordisk and Novo Nordisk Pharmatech are regularly
audited by major and minor pharmaceutical companies and inspected by the Danish Medicine Agency.

Our comprehensive documentation and services include:

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

Our new environmental strategy, Circular for Zero, sets out targets and milestones for the next 10 years of this journey. Our ambition is bold and simple: to have zero environmental impact.

We will collaborate proactively with suppliers to embed a circular mindset for reduced environmental impact across our value chain and switch towards circular sourcing and procurement.

We will eliminate the environmental footprint from our operations and drive a circular transition across the company to achieve our zero environmental impact ambition.

We will upgrade existing and design new products based on circular principles and solve the end-of-life product waste challenge to close the resource loop.

Novo Nordisk is a member of the UN Global Compact and World Business Council for Sustainable Development (WBSCD). As a fully owned subsidiary, we follow the general policies of Novo Nordisk for sustainability, business ethics and code of conduct.

We believe that a healthy economy, environment and society are fundamental to long-term business success. This is why we manage our business in accordance with the Triple Bottom Line (TBL) business principle, conducting activities in a financially, environmentally and socially responsible way.

Our highly qualified personal work continuously on product development and improving documentation, to suit your needs and the ever-increasing global regulatory requirements.

Working with us is a great asset to minimize risk, as part of your risk management strategy.

Our expertise – together with product and documentation availability and global compliance – has made Novo Nordisk Pharmatech a preferred supplier to leading biopharmaceutical companies worldwide.