By Tatiana Nanda, Head of Process Development for Cell Therapies, Drug Product and Process Analytics, and Nikhil Tyagi, Director of Cell Therapy Process Development, Center for Breakthrough Medicines
The science behind advanced, cell-and-gene-based drugs is developing rapidly, opening new opportunities for targeted, highly effective therapeutics. Around the world, companies are currently researching thousands of these lifesaving drugs. However, manufacturing them on a large scale presents logistical challenges that often result in a slow, costly process.
Unlike chemically based drugs, cell-and-gene therapeutics may require a complex scale-up strategy, progressing from preclinical research to clinical trials and ultimately to commercial manufacturing. These technological challenges can delay the entire drug development process and reduce companies’ return on investment (ROI). However, contract development and manufacturing organizations (CDMOs) are uniquely positioned to solve this problem. As emerging technology influencers, they fill the gap between cutting-edge science and the commercial sector by partnering with the best technology providers to maximize the manufacturing process.
Pharmaceutical companies often prioritize their capital investment to develop new indications and modalities, so when they invest in manufacturing, they are frequently focused on a single platform. Investing in multiple technologies or pivoting to a new manufacturing process isn’t always practical for many pharmaceutical companies, especially startups and smaller biotech. However, CDMOs have the agility to invest in numerous platforms, develop partnerships with various technology providers, and guide companies to the best fit for their drugs. CDMOs are the matchmakers of the pharmaceutical industry, bringing pharmaceutical and life science technology suppliers together to create mutually beneficial partnerships.