As drug pipelines diversify and timelines shorten, Dr. Victor Vinci, Chief Scientific Officer and Vice President of Process Development at Cook Pharmica, sees CMOs playing a key role in the future of the bioprocessing industry.
Speaking to us at BioProcess International 2015, he described how the current trends in the wider industry present both challenges and opportunity to CMOs: “The pipelines of the major companies and small biotech companies are full of innovative new products, which suggests a very busy landscape for needing help in manufacturing and development.”
Additionally, not only is the range of products increasing, but “we see a need for speed as many molecules are moving quickly through pipelines – some of designated Breakthrough Therapy – which suggests the longer traditional pharma timelines need to be shorter and CMOs should have a part to play in that.”
Dr. Vinci sees tech innovation as vital in meeting these challenges, specifically perfusion and use of disposable equipment. Yet he also sees the very structure of the industry changing, explaining: “Recent consolidation in the CMO business is suggesting more clients are going to a one source offering having the entire package.”
As the technology gets ever more complex and therapies more varied – “We see increasing novel therapies beyond just MaBs” – the risks CMOs are facing correspond:
“The big risk from a technology standpoint is we’re often inheriting a client’s platform and although platforms are somewhat consistent across the industry, there are always unique differences. We also inherit the complexity and the potential risk of a client’s molecule and how it will behave during processing.”
For Dr. Vinci, the way to mitigate such risks is refreshingly old-fashioned; communication. He reveals that “the key is to have a discussion with the client, agree that we understand the risks and agree how we are going to mitigate and co-own the risks. The initial discussions are reviewing the process data, their intentions for what they are going to do in the clinic and what their past experience has been.”
The process is often a long, ongoing one, with new discoveries around every corner:
“What often happens is we get into the deeper part of tech transfer, and we learn more things about the client’s process or their molecule and that becomes a second round of discussions with their technical experts of quality systems people.”
Overall, it is clear from Dr. Vinci that CMOs act as a microcosm of the wider industry, reflecting the same enormous change, excitement and complications facing everyone at the moment.
Watch the full interview with Dr. Victor Vinci above.
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