ARTICLES BY LOUIS

• AI Stuck Upstream? It Still Influences Manufacturing Outsourcing

  5/21/2026

  AI may help run and optimize bioreactors at your CDMO. There is pervasive pressure to move manual (and reactive) control to AI-autonomous (predictive systems). You may already select your CDMO partially based on its systematic utilization of AI in its facilities. But at this moment of transition, while the odds are high AI may not fully reside in the manufacturing plant today, it increasingly shapes the decisions determining what and how programs get to that plant.

• Kodak's CEO Leans Into Biopharma Manufacturing – "I'm An Operator"

  5/18/2026

  Kodak’s Eastman Business Park in Rochester was the focus of a recent editorial. But the man leading Kodak’s comeback, Jim Continenza, Chairman and CEO, is a topic unto himself. He’s as animated as any public-company CEO you’ll encounter. And he knows his audience; in his conversation with Chief Editor Louis Garguilo he says Kodak “has always supplied CDMOs and the industry with important chemicals.” Read his vigorous take on domestic manufacturing and other supply-chain topics.

• Early CDMO Engagement For Cell Therapies? CellProthera's CEO Thinks Not

  5/14/2026

  Tokyo Institute of Technology. London Business School. ETH Zürich. What do these institutions – and a biotech based in Mulhouse, France – have in common? Matthieu de Kalbermatten, CEO of CellProthera. His international experience adds up to this: Build an internal quality (cGMP) organization; become the master of the processes you create for your therapy, before moving to external help; then select your CDMO carefully – maybe just prior to Phase III.

• Can A Biotech Create A CDMO Market?

  5/11/2026

  Can a biotech create a CDMO market? GeoVax, an infectious disease/oncology biotech, may have just done so. David Dodd, CEO, believes we should all concentrate more on whether the outsourcing model can align with evolving technology platforms. Both sponsors and CDMOs may need to change things up.

• Kodak Flips The Script To Biopharma Manufacturing In Rochester

  5/4/2026

  Well, that didn’t work out as planned, writes Chief Editor Louis Garguilo, referring to Kodak's plan in 2018 to revitalize the Eastman Business Park in Rochester, NY. The incoming chairman and now CEO, Jim Continenza, didn’t like that movie, and flipped the script. Instead, Kodak has, so to speak, returned to itself – back to a domestic specialty materials and chemicals supplier, intent on serving biopharma in that capacity.

• Cell And Gene Therapy CDMOs: On The Path To $75 Billion in Services?

  4/30/2026

  Cell and gene therapy (CGT) developers – and thus their service providers – have had their share of ups and downs. But what do the promise and uneven realities of these therapies add up to in the development and manufacturing outsourcing sector? According to a Towards Healthcare report, despite the bumps in the road, in 2025 the global CGT CDMO market grew to $8.2 billion. What of future predictions? Here's a detailed analysis.

• FDA Letters Made Public Are Creating New Risks

  4/23/2026

  There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake.

• A CMC Professional At Sanofi Focuses On Collaborations (And The Right Questions)

  4/20/2026

  Manda Pasarkar, Global Regulatory Affairs, CMC Head, Sanofi, has overseen global, multi-billion-dollar portfolios of products from early development to commercialization. She spoke with Chief Editor Louis Garguilo on her outsourcing strategy and philosophy.

• Why A Cell Therapy CEO Waited Until Phase III To Outsource

  4/16/2026

  Sometimes, you have to go it alone. For a while, at least. The mantra across biotech has long been clear: engage your CDMO early, and let those experts guide you into manufacturing. Matthieu de Kalbermatten, CEO of CellProthera, a regenerative cell-therapy developer, begs to differ.

• Forget Tech Transfer. You Need A Cognitive Connection

  4/13/2026

  Cognitive transfer is a concept widely studied in psychology. Today it has growing relevance within our industry’s ever-increasing technology transfers, which have been understood in the main as moving development/manufacturing processes/technologies from one stage, one location, or one organization – as when utilizing CDMOs – to another. Time now to zero in on the communicating of tacit or implicit knowledge, i.e., knowledge or experience difficult to extract through data or written explanation. This is where cognitive transfer enters our portal. Here's an analysis.