Novo Nordisk 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.

Pharmaceutical Grade

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.

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.

Sustainability and triple bottom line

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.