Novo Nordisk Pharmatech is a leading provider of recombinant insulin, supplying it as a crucial ingredient for the biomanufacturing of over 100 therapeutic drugs available in today’s market. With a rich heritage, we take pride in offering a superior quality product that reflects our extensive experience in serving customers worldwide.
Our commitment to delivering the most stable and well-established manufacturing processes, coupled with our specialized knowledge in supplying ingredients to the biopharmaceutical and pharmaceutical industries, sets us apart. We take pride in fulfilling our promises, delivering on-spec products, and ensuring timely delivery. Global large biopharmaceutical companies rely on our Recombinant Insulin for the production of their life-changing drugs.
The manufacturing of our Recombinant Insulin takes place in yeast, eliminating any concerns about animal-related components. This organism is not cultivated or stored in media containing animal elements and does not possess genes or express antigens associated with livestock or poultry diseases. Our Recombinant Insulin meets the requirements of major cell culture media suppliers for animal-free products. We have replaced trypsin, used during insulin manufacture, with a proprietary process aid of non-animal origin. Additionally, our Recombinant Insulin is free of antibiotics. Recombinant Insulin adheres to the guidelines outlined in the ICH Q3C Note for Guidance on residual solvents.
Our Recombinant Insulin is manufactured in large-scale bulk batches, primarily as a supplement for cell culture media. It fully complies with the stability testing guidelines outlined in ICHQ1 for new drug products. Consistency in batch-to-batch quality is a hallmark of our Recombinant Insulin.
Novo Nordisk Pharmatech’s Recombinant Insulin is provided in a dry crystalline form, which can be easily dissolved in water. With a shelf life of five years, proper storage and handling are essential throughout this period. The product is dispensed in HDPE plastic containers, placed within tamper-proof plastic bags. These containers, along with sufficient dry ice, are then packed in approved thermo containers, which are further enclosed in cardboard boxes. This meticulous packaging ensures that the product remains below the recommended maximum temperature during transportation. Depending on the volume of the primary plastic containers, either a small or large shipment box is utilized.
Our customers can have the utmost confidence in our robust risk mitigation strategy. All manufacturing and quality control activities are centralized in Denmark, and our supply chain is limited to Scandinavia. We strategically position our insulin manufacturing plants in regions characterized by secure geographic, weather, political, and civil conditions. We maintain safety stocks at multiple secure locations and maintain complete traceability throughout the supply chain.
To maintain the product within specifications, it is crucial to store our Recombinant Insulin at freezing temperatures, below -20°C. However, the product can withstand short periods at refrigerator or room temperature.
Recombinant Insulin is sourced directly from our parent company, Novo Nordisk, the world’s largest manufacturer of insulin. The manufacturing of insulin follows ISO 9001 Quality Systems and cGMP compliance, meeting all relevant European and US guidelines and pharmacopoeia. Our manufacturing facilities undergo regular inspections by the US FDA, and both Novo Nordisk and Novo Nordisk Pharmatech receive frequent audits by pharmaceutical companies and inspections by the Danish Medicine Agency.
In 2023, we celebrate a significant milestone as Novo Nordisk Pharmatech commemorates 100 years of Novo Nordisk insulin. This achievement fills us with excitement, knowing that we are part of a historical company that has been driving medical advancements since 1923.
Just over 100 years ago, diabetes was considered a death sentence for patients. Before the discovery of insulin in 1921, diabetes posed a fatal threat to those affected by it. Insulin, first isolated from a dog’s pancreas in 1921, saved the life of the first diabetic patient when administered in 1922. In March 1923, Novo Nordisk insulin became available, setting the stage for a century of innovation in protein-based treatments for individuals battling serious chronic diseases.
Beyond its life-saving benefits for diabetic patients, insulin also proved to be beneficial for scientists studying protein structure and chemistry, leading to numerous technological milestones.
Initially sourced from porcine, insulin later transitioned to being produced as a recombinant protein in microbial organisms. Subsequently, recombinant insulin became a vital component integrated into the manufacturing processes of other therapeutic proteins, such as monoclonal antibodies. Due to its biological activity, insulin plays a role in various intracellular pathways, fostering cell proliferation and protein production.
We collaborate with major companies manufacturing blockbuster drugs, striving to provide high-quality raw materials and contribute to the production of life-changing therapies.
From the well-established biomanufacturing of monoclonal antibodies to the emerging field of advanced therapies, we are honored to be the trusted partner for numerous therapeutic drug manufacturing companies. Our unwavering commitment to maintaining high quality and reliability remains constant across all endeavors.
Our team of cell culture experts, along with dedicated customer support, stands ready to provide comprehensive information about our products and explore future collaboration opportunities with our customers.
In the biomanufacturing field, finding the right ingredient for success makes a meaningful difference, and we are proud to play that role.