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New Superior Enzymes and Customised Purification Resins for Biopharma and Regenerative Medicines

Novo Nordisk Pharmatech is developing a portfolio of speciality enzymes and customised resins for the biopharma and regenerative medicines market. We will start with the launch of a superior GMP- (Good Manufacturing Practice) grade recombinant trypsin this year and continue to grow our portfolio and launch new products over the coming years with further enzymes and purification resins.

The 2021 launch of our recombinant trypsin will provide the market with a high-purity and consistent-activity product manufactured under Current Good Manufacturing Practice regulations (cGMP) and from non-animal derived raw materials. This makes it superior and ideal for bioprocessing and regenerative medicines applications, as the director of research and development (R&D) at Novo Nordisk Pharmatech Kristoffer Laursen explains. Laursen says that “the enzyme offers a very consistent activity, where the activity level is specified on a very narrow range, enabling a more robust process and improved productivity. For example, for stem cell applications, this is especially beneficial for increasing your yield in cell attachment. Customers will also find our full documentation package an advantage, supporting their dialogue with authorities since the use of such enzymes can be applied very close to the patient.”

Expanding our enzymatic profile and custom resins for 2025

Our R&D team focuses on expanding our enzymatic portfolio over the next several years to offer speciality enzymes where superior functionalities are needed. For example, this could be working over wider ranges of temperatures, pH or salt concentration. These enzymes also come with the benefit of high-level purity, cGMP manufacturing and a non-animal origin. “While there are many enzymes that cover many different uses in other markets, our enzymes are developed specifically for the pharma market. Our speciality enzymes provide superior functionality and quality, where an off-the-shelf solution won’t do,” Kristoffer says.

We are also developing resins for the purification market for customers working in low volumes while requiring high-quality and customisation levels. “We look forward to offering resins with customised characteristics, such as hydrophobic or ionic resins. We have a ‘library of resins’, you could say, and from there, we can collaborate closely with customers to modify different ratios of ligands or different strengths, for example, to meet each customer’s specific needs,” Kristoffer explains. This can help our customers improve their productivity and purity in an even more cost-effective way, especially within the regenerative medicines space.

“These two product groups also have an interaction that is quite interesting,” adds Kristoffer. “Our R&D team will be exploring a purification resin with enzymatic functionality. We believe an immobilised enzyme attached to a resin would provide significant advantages, where you could reuse enzymes to both drive down costs and reduce your environmental impact.”

Meeting future needs and trends

The regenerative medicines market holds much promise for new technologies that can greatly improve the outlook and quality of life for people with genetic or autoimmune diseases.

“Since the vision of Novo Nordisk Pharmatech is to enable better medicines, this is exactly the area that we must focus on. We are in the early days, but there’s no doubt that this new type of therapy will take over,” adds Kristoffer.

“It’s just a question of how much and how fast! The diversity of new raw materials needed for regenerative medicines is huge, and the quality of these is critical. This is where we believe our speciality enzymes and custom resins, in addition to our insights and experience from biopharma, can add significant value to the regenerative medicines industry.”

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