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.
For example, at the Center for Breakthrough Medicines (CBM), we know that adherent process scalability is one of the biggest hurdles to manufacturing cell and gene therapies. Frequently, companies find that the methods that worked for preclinical research or even Phase I and II trials can’t produce the same quality or quantity of product needed for Phase III and commercial. They often must switch between platforms, requiring complex comparability studies and potentially creating costly delays.
Due to their customized nature, each therapeutic has precise manufacturing needs, depending on the process and the product. Some therapies can be scaled up in a matter of days, while others take months to grow the cells and develop the therapeutic. One-size-fits-all solutions don’t work well with these therapies, so this is where a CDMO, who has invested in multiple technologies and can offer the best solution for your product, can be helpful.
一个CDMO scalabilit应该有一个行动计划y at the beginning of its partnership with a company that does not involve expensive platform changes or unproven technology. While presenting their plan for manufacturing, the CDMO should provide evidence that their large-scale methods work by sharing research and whitepapers that support their modalities. One-size-fits-all solution proposals are a red flag that the CDMO hasn’t thoroughly researched each therapy’s particular needs.