The COVID-19 pandemic led to companies turning to CDMOs they were unfamiliar with due to a shortage of CDMO capacity. That’s according to Georgia Sloboda, managing director for chemistry, manufacturing, and controls (CMC) at the Latham BioPharm Group. Sloboda and her colleague, Patrick Falvey, principal consultant at Latham, gave a talk about selecting a CDMO at CPHI Frankfurt last November.
“[The pandemic] forced companies to look at alternatives [and that] gave a huge opportunity for companies, who had less of a [famous] name or [large] capacity, to really shine and deliver for their clients,” notes Sloboda, adding that another recent trend in CDMO selection includes clients wanting smaller batches to get proof-of-concept for therapies.
Debates over single-use technologies are also a major trend in the industry, with CDMOs sometimes combining fixed traditional equipment with single-use technologies to reap the benefits of both.
“Disposables save time and money as you don’t have to sterilize components beforehand and it helps with cleaning validation,” Falvey explains. “Using single-use equipment for the downstream part of the process makes companies more agile, and able to scale up. And the more agile the CDMO, the better placed to bring client products to market.”
Sloboda recommends choosing a CDMO with a good cultural fit. “You can have technically the greatest fit, but if there isn’t good communication, your project can just become a number,” she says.
Part of a good cultural fit is what Falvey calls the “engagement factor.” He gives the example of a project where the CDMO’s site lead and European development manager were on the first couple of calls with the new client.
“The top CDMOs take the extra step to ensure your company’s success is their success,” he points out. “They complete paperwork promptly, are transparent about their culture, and show up with senior directors to meetings.”
Falvey also recommends choosing a CDMO with a roadmap for successful delivery of client projects, especially where—as increasingly happens—the client is a virtual company with no infrastructure.
“I like CDMOs that can troubleshoot issues and come up with a range of solutions, rather than expecting [the client] to solution it themselves,” he says.
Sloboda agrees, emphasizing that with any project the question isn’t whether there will be issues, but when issues will occur. In all these cases, Sloboda and Falvey emphasize the importance of communication and building long-term relationships with your CDMO.
“What today’s client is looking for, in most cases, is a long-term partner,” says Sloboda. “They don’t want to go through the CDMO selection process multiple times.”
