Approximately 75,000 enzymes are thought to exist in the human body as vital catalysts for biochemical reactions or conversions. For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The pharmaceutical industry often relies on enzymes to perform a process known as biocatalysis, which facilitates the cost-effective and sustainable production of small molecule drugs at scale.
Meanwhile, the pharma industry is undergoing somewhat of a transformation itself. The next wave of medicine is well on course to be cell and gene-based. In September 2021, GlobalData figures revealed there to be 1,320 industry-sponsored regenerative medicine and advanced therapy trials ongoing worldwide. Continuing advancements within this field deliver new hope to doctors and patients, transforming disease outcomes for previously incurable indications.
In the evolving biotechnology industry, 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,” explains Kristoffer Laursen, Head of R&D at Novo Nordisk Pharmatech. “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, just to mention some examples. You can also use enzymes for product quality assurance, for example, to digest residual nucleic acid in the downstream process, enabling recombinant proteins to meet regulatory guidelines.”
The specificity, consistency, and quality of the enzyme are highly critical for the pharmaceutical and biopharmaceutical space. “For cell and gene therapy applications, you need a variety of speciality 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.”
Developing best-in-class speciality enzymes
In 2021, Novo Nordisk Pharmatech, announced plans to enter the enzyme market. According to Laursen, the decision to break into speciality enzymes was based on a look into the future of the biopharma market and an important assessment of how the company believes it can make a genuine difference.
By building upon its core competency, Novo Nordisk Pharmatech will begin serving the emerging regenerative medicine and advanced therapy markets through best-in-class speciality enzymes. Advantageous synergies within the Novo family make this a possibility.
Novo Nordisk Pharmatech is drawing from the insights and expertise of its mother company, Novo Nordisk, which invests in many new therapeutic modalities itself. “That is a key competitive advantage,” says Laursen. “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 that is probably the best player in the market within enzyme diversity. And it’s within the family – Novozymes!”
“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 speciality 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.”
The impact could be huge for the biopharma industry. 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.
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.
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.
Novo Nordisk Pharmatech is excited to support the new modalities at the very forefront of the biopharma industry. In partnership with Novozymes, the R&D department is currently working hard to develop a portfolio of speciality 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 a sustainable way. “Innovation is unlocked from our culture and dynamic team diversity,” says Laursen.
“In recent years, we have intensified our efforts to ensure a more diverse workforce within our strategic focus areas, and equally important, a creative environment where all employees feel safe to propose novel ideas – that is actually at the core of R&D,” he says. “A diverse workforce improves our decision-making and ensures we are not moving in an unconsciously biased direction. We also experience that it helps us broaden the pool of talent we can recruit from and assures a lot of new global talent in the company”.