Tech Transfer into a CMO
Technology transfer, which involves making process and molecule data available to a CMO, is an essential part of working with a contractor. Its success, says Susan Dexter, principal consultant at Latham Biopharm Group, depends on how well the sponsor understands their molecule, the process, and the extent to which they share that knowledge.
“Tech transfer goes well when sponsors are knowledgeable and open. Historical information is useful if the project is being transferred into development at the CMO, to get a sense of what worked and what didn’t,” explains Dexter.
“The more the sponsor shares with the CMO, the more likely the tech transfer goes well. Sharing information helps mitigate risk of failure.”
Tech transfer comes in two main varieties. One involves well-defined processes destined for manufacturing. The other, which is riskier, occurs during development, where the CMO is expected to develop and optimize the process. In either case, Dexter says, successful tech transfer demands presenting all available process and molecule data, historic and current.
Some CMOs initiate a project through a formal questionnaire that covers expression, cell lines, media, process conditions, scaleup, purification, analytics, and other relevant aspects of the project. This gives CMOs a better idea of knowns and unknowns of the sponsor, so facilitates dialogue.
“It boils down to openness and communication,” notes Dexter. “It’s critical that the receiving party understand what has worked and what has not, so as not to repeat activities that have been non-productive.”
Try as they might, CMOs do not always receive all the data they need to conduct a development, scaleup, or manufacturing campaign. The reasons for sponsors holding back vary.
Foremost is the sponsor’s corporate culture. Biopharmaceutical companies are trained to be protective of their intellectual property and know-how, even when aspects of it are public.
“Holding back may not even be deliberate, sometime it’s just habit,” explains Dexter. “Just as technical manuals often assume end-user familiarity that may not exist, sponsors may believe that CMOs should already know certain aspects of development or production, even if they are specific to that product. A good deal of what should be ordinary communication is based on assumptions.”
One way to avoid this situation is for the CMO to spend time at the client’s facility and to work with the sponsor’s team. This, according to Dexter, can help foster trust and understanding, and overcome some of the inherent communication barriers.
“It’s more like showing the CMO how to do something instead of explaining it,” says Dexter.