What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? Scorpius Biomanufacturing’s regional vice president of business development, Steve Lavezoli, shares his thoughts with Contract Pharma.

Interest in integrated services
CDMOs that can provide end-to-end support from preclinical development through commercialization to post-launch, including all ancillary services, such as analytical and regulatory, will help clients simplify their supply chains while also reducing the time and cost of drug development. Integrated process and analytical development expertise enables the design of robust processes while reducing time to the clinic. They are also able to form true collaborations and work on a more intimate level with open and transparent two-way communication and cooperative strategic planning. Separately, strategic collaborations with other service providers offering high specialized capabilities supplement the end-to-end services where appropriate.

Increase in the percentage of small volume products
Successful CDMOs must be sufficiently flexible in terms of capacities and capabilities to support not only clinical and commercial projects, but products designed to treat both large and small patient populations. They must have demonstrated experience and expertise in the development and manufacture of a diverse array of drug substance types. For biopharma CDMOs, that includes conventional recombinant proteins and monoclonal antibodies, as well as next-generation molecules, such as antibody fragments, multi-specific antibodies, cell therapies, and more, produced via both mammalian cell culture and bacterial/yeast fermentation processes.

Talent and raw material shortages
The pharmaceutical industry is facing a shortage of highly skilled and qualified experts to fill roles from manufacturing to quality. The ongoing COVID-19 pandemic and its impacts in various regions of the globe combined with general labor shortages around the world is extending supply chain issues despite significant investments by many single-use component, plasmid DNA, and other raw material suppliers in capacity expansions and greenfield facilities. The CDMO sector is impacted by both concerns. Only those CDMOs that have strong relationships with local, national, and international talent sources and strategic collaborations with suppliers can ensure successful staffing and ongoing, on-time supply of materials critical for the manufacture of client products.