Contract Pharma Manufacturing editorial
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Outsourcing Nirvana At Eli Lilly
3/4/2024
Mark Butchko has been at Eli Lilly for 24 years, currently serving as Associate Vice President - Global Quality Laboratories. He draws from that longevity to describe what he’s currently experiencing, and what the future of outsourcing might look like from his vantage point.
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Green Gains In Biopharma Without Closing Facilities?
2/29/2024
Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.
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How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing
2/27/2024
To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
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Process Mapping For More Effective Knowledge Management
2/26/2024
It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.
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Is WuXi AppTec An Enemy Of The State?
2/20/2024
I have zero sympathies for the Chinese communist regime. My stance on tariffs and other economic and market-access blocking measures to combat the regime is more ambivalent. But is WuXi AppTec an enemy combatant against the citizens of the U.S., as proposed legislation assumes?
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Why Are Cell-Therapy Outsourcers Unhappy? Investors Know
2/19/2024
Some private research indicates cell-therapy sponsors aren't happy with outsourcing options. In this part two with a successful investor, we find out how that sentiment might change for the better.
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CDMO Carve Out Specialists
2/13/2024
How do investors influence our outsourcing ecosystem? Chief Editor Louis Garguilo asked one. But not just any investor. He spoke to a CDMO “carve out” specialist, who provides a window into how investors, sponsors, and CDMOs come together, and come apart.
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Trends In FDA FY2023 Inspection-Based Warning Letters
2/13/2024
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
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Novo Holdings Clarifies, But Competitors Circling Catalent
2/12/2024
Novo Holdings has responded directly to our request for a more definitive disposition of Catalent once it is acquired by the private investment company Novo Nordisk. The quick reply is fortuitous; competitors are circling.
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What Does The Catalent Acquisition By Novo Holdings Mean For The Biopharma Industry?
2/12/2024
Novo Holdings, the parent company to Novo Nordisk, announced a deal last week to acquire Catalent, the global CDMO, at a value of $16.5bn. In the same breath, Novo Holdings announced they will sell three sites directly to Novo Nordisk, implying that the rest of the assets of the company will continue to operate as a stand-alone CDMO. This article unpacks the acquisition, discussing questions such as “what does it mean for customers?” and “does this deal reshape the CDMO market?”