By Novo Nordisk…
Novo Nordisk Pharmatech developing speciality enzymes for innovative drug therapies
Koege, Denmark: – World-leading recombinant insulin and quaternary ammonium compounds (Quats) specialist Novo Nordisk Pharmatech A/S is developing a range of specialty enzymes that have the potential to markedly reduce the cost of manufacturing NextGen medicines.
The R&D department at Novo Nordisk Pharmatech is currently working in partnership with enzyme discovery and design specialist Novozymes to develop a portfolio of specialty enzymes, starting with a recombinant trypsin product. The team’s mission is to develop innovative and customized pharmaceutical materials that enable better medicines for the market in more sustainable ways.
Best-in-class specialty enzymes
In 2021, Novo Nordisk Pharmatech, announced plans to enter the enzyme market, based on a re-assessment of the future biopharma market and ways in which it could add value to processes.
By building upon its core competency, Novo Nordisk Pharmatech will begin serving the emerging regenerative medicine and advanced therapy markets through best-in-class specialty enzymes, leveraging from advantageous synergies within the Novo family.
Novo Nordisk Pharmatech will thus draw on insights and expertise of mother company, Novo Nordisk, and its own investments in many new therapeutic modalities.
“That is a key competitive advantage,” said Dr. Kristoffer Laursen, Head of R&D at Novo Nordisk Pharmatech.
“We also benefit from having cGMP manufacturing capabilities in compliance with global regulatory requirements, a strong heritage from our mother company’s brand, a proven track record of reliable and secure supply, and a new partner, Novozymes, that is probably the best player in the market within enzyme diversity and also part of the Novo Nordisk family,” Dr. Laursen explained.
“This venture is a perfect match; we complement each other. Novozymes has a long legacy of enzyme discovery and the ability to genetically engineer these specialty enzymes to be superior. What Pharmatech does is translate the customer needs into a desirable product profile. After joint development, screening, and proof of concept, we purify the selected enzyme intermediate from Novozymes under cGMP conditions. Finally, Pharmatech commercializes the validated pharmaceutical grade product through our well-established B2B sales platform and customer network, supplying some of the largest pharmaceutical companies worldwide,” said Dr. Laursen.
The impact could be huge for the biopharma industry, which is embracing a new wave of medicines that will be increasingly cell and gene-based, transforming disease outcomes for previously incurable indications. In September 2021, GlobalData figures identified more than 1,300 industry-sponsored regenerative medicine and advanced therapy trials worldwide.
As the industry defines higher quality and cost-effective processes for producing cell and gene therapies, enzymes will play a key role, helping companies deliver more accessible and affordable therapies to patients.
Superior specialty enzymes will help drive down manufacturing costs by increasing productivity and reducing the amount of raw materials needed. According to Laursen, raw materials currently contribute up to 50% of the costs of producing these advanced therapies.
Further opportunities arise from the industry’s move towards sustainability. Companies replacing chemical processing aids with biocatalysts, using enzymes as part of a greener manufacturing model less reliant on environmentally critical raw materials, will emerge as front runners.
In this evolving biotech sector, enzymes are important process aids.
“Specialty enzymes are proteins that can act as very specific biocatalysts to accelerate reactions and produce the desired target molecule in pharmaceuticals,” says Kristoffer Laursen.
“In the pharmaceutical industry, specialty enzymes play a major role in a variety of applications across several therapeutic modalities, most commonly for modification but also to reduce viscosity and thereby improve processability, and to attach and de-attach cells which increase productivity, for instance.
Enzymes are also used to assure product quality assurance, including digesting residual nucleic acid in the downstream process or enabling recombinant proteins to meet regulatory guidelines.
Specificity, consistency, and quality of the enzyme are thus highly critical for the pharmaceutical and biopharmaceutical space. “For cell and gene therapy applications, you need a variety of specialty enzymes of the highest purity, specificity, and consistency. The quality grade is even more important in many novel therapeutic modalities because the specialty enzymes often form an integral part of the product and are closer to the patient. The enzymes must be manufactured under cGMP conditions – completely free of animal-derived ingredients,” notes Dr. Laursen.
About Novo Nordisk Pharmatech A/S
Novo Nordisk Pharmatech A/S is a global and leading manufacturer of pharmaceutical aids for the pharmaceutical and biopharmaceutical industries. The company specializes in producing quaternary ammonium compounds (Quats) used as active pharmaceutical ingredients (APIs) and excipients as well as delivering Recombinant Insulin for use in cell culture media to enhance cell growth and viability, and productivity.
Novo Nordisk Pharmatech A/S helps the world´s largest pharmaceutical and biopharmaceutical industries reduce their risk for raw materials by using pharma-grade products with a high level of consistency, purity, quality, and reliability.
Novo Nordisk Pharmatech A/S was established in 1949 as Ferrosan Fine Chemicals and acquired by Novo Nordisk in 1986. The company is operating as a division of Novo Nordisk A/S from Køge, south of Copenhagen.
You can learn more about Novo Nordisk Pharmatech at novonordiskpharmatech.com.
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Click on Meet Kristoffer Laursen to view video about the R&D department at Novo Nordisk Pharmatech.