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Insulin manufacturer
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.
100 years of excellence
In 2023, we celebrated a significant milestone as Novo Nordisk Pharmatech commemorated 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.
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 groundbreaking drugs.
Why our Recombinant Insulin sets the standard
High purity, recombinant, animal-free product
Batch-to-batch consistency
Reliable and experienced partner, with +100 years experience in insulin
Secure improved cell growth and protein yield
Following global regulatory compliance
Recombinant Insulin applications
As an experienced insulin manufacturer, Novo Nordisk Pharmatech provides high-quality Recombinant Insulin that plays a critical role in serum-free growth media for mammalian cells. Our insulin is widely used as a supplement in cell culture media for cell lines such as CHO, HEK293, and Sf9, supporting the biomanufacturing of monoclonal antibodies, virus vaccines, and gene therapy products.
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Animal-free and antibiotic-free manufacturing
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. Neither the cell bank nor the manufacturing process involves any animal-origin components. We have replaced trypsin, used during insulin manufacture, with a proprietary process aid of non-animal origin. Additionally, our insulin is free of antibiotics. Our Insulin Human AF adheres to the guidelines outlined in the ICH Q3C Note for Guidance on residual solvents.
We manufacture our Recombinant Insulin in large-scale bulk batches, primarily for use in cell culture media. Each batch meets the rigorous stability testing requirements of ICHQ1 for new drug products. Consistent batch-to-batch quality is a defining feature of our insulin, providing our customers with reliability and confidence in their production processes.
Packaging, shelf life, and temperature control
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 tamper-proof plastic bags, placed within HDPE plastic containers. 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.
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.
Supply chain and regulatory compliance
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 manufacturing facilities 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.
Adhering to the highest quality standards, our quality management system complies with DS/EN ISO 9001 for all our activities. Our Insulin Human AF is sourced directly from our parent company, Novo Nordisk, the world’s largest insulin manufacturing company. 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 undergo frequent audits by pharmaceutical companies and inspections by the Danish Medicine Agency.
100 years of innovation in insulin manufacturing
We take immense pride in celebrating a century of Novo Nordisk as an insulin manufacturer, sharing our expertise and dedication to enabling better medicines. 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 a boon 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.
Partnering with the world’s leading drug manufacturers
We collaborate with global manufacturers of 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 manufacturers. 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.
Additional resources
Explore more about Recombinant Insulin
Insulin insights
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Insulin 10 reasons why
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Insulin applications
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