ARTICLES BY LOUIS

• FDA Not A Good FRAME for CDMO Inspections?

  9/21/2026

  Is the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) a good idea? It dates to 2019, but as of this July, the FDA has proposed a regulatory pathway allowing a distributed manufacturing establishment (DME) to operate as a single registrant covering multiple locations. Let's look at a real-life example to weigh the merits.

• Wasted Words: Improving Content At Conferences

  9/14/2026

  In-person events should be a tool for separating the noise from authentic signals. Through “content design,” the best conferences provide you direct market insights via information aggregation, discussion, and business meetings. The founders of CDMO Live conferences speak with Chief Editor Louis Garguilo on “curating" events for optimal development and manufacturing outsourcing outcomes. In short: No wasted words; no wasted time.

• The External Partners Delivering The Components Of RNA Therapies

  9/10/2026

  “RNA-based therapeutics” is now a diverse and wide field of application; outsourcing the components of these programs is challenging. Executives at the Society For RNA Therapeutics (SRT) say assembling an entire supply chain can soak up time and resources. Which partners to select depends on what area of RNA development you are pursuing. A fundamental task before all RNA sponsors is thinking deeply in terms of assembling development and manufacturing ecosystems, starting at the earliest stages of research and company formation.

• Don't Fear The Machine – A Biologist Explains AI In The BioPharma Industry

  9/7/2026

  "I should have known," writes Chief Editor Louis Garguilo, "It takes an accomplished biologist to most effectively describe the significance of artificial intelligence in our outsourcing industry, and put it to practical use." That professional is Damiano Dragone, Founder & Principal Advisor, Dragone Consulting, who built a career across pharmaceutical quality and data-driven quality environments within the biopharmaceutical industry, and was an early proponent of the promise of AI in quality, development and manufacturing, and the supply chain. 

• Catalent Says It's Not Our Facility; It Belongs To Novo Nordisk

  9/3/2026

  The FDA informed us again in April that the Bloomington, Indiana, facilities owned by Catalent until sold to Novo Nordisk in December 2024, have not solved quality issues. This adds to an FDA inspection/poor response and remediation history years long in the making. How is it we are witnessing this at a U.S. facility run by a name-brand CDMO and then Big Pharma? Catalent, for its part, wants to stop "inaccuracies in media coverage." Here's analysis from an experienced pharma professional and our own Chief Editor Louis Garguilo.

• ATMP Development Gets A Boost From Outsourcing Best Practices

  8/31/2026

  Innovation requires new thinking and approaches. It also heightens the need for disciplined execution. With ATMP development – as well as with any program – starting out on a path lined with outsourcing principles may prove your greatest competitive advantage. A discussion from Chief Editor Louis Garguilo.

• The U.S. Supply-Chain Uncovered: A Superior Search For Domestic Suppliers

  8/24/2026

  The search for supply chain partners goes on. Intensely. But productively? Are we missing anything? We are about to learn the answer to that is yes.  Alan Davis, President & CEO, i5 Services says puzzling is how little these searches vary – and he's concerned that invariance has negative national supply-chain implications. He has a mission and a search platform to change that.

• Outsourcing Growth, And The Cold (Storage Monitoring) Truth

  8/17/2026

  Chief Editor Louis Garguilo superimposes two reports: one on a precise subject, cold chain monitoring; the second an analysis of the entire contract manufacturing market.  What brings the two together? "Growth, its various components, and interpretations." The cold chain monitoring report is prime example of the components of growth demonstrated in the overall biopharma outsourcing market report.

• Lower Court Agrees With WuXi AppTec (And Many Of Us)

  8/14/2026

  A lower-court ruling does not make a victory. But it adds a little sanity to this melodrama. On August 7, a U.S. District Judge did something that has been surprisingly rare in the long-running WuXi AppTec/BIOSECURE Act saga: He looked at the U.S. government's case for labeling WuXi a “Chinese military company” and decided the government had not shown enough evidence. Analysis from Chief Editor Louis Garguilo.

• Mission-Driven Professionals And Students Build America's Supply Chains

  8/10/2026

  Tales of purpose-led careers that bring innovations to business leaders and opportunities to university students. They inspire us. Chief Editor Louis Garguilo documents two such professionals who have combined to help domestic manufacturing organizations locate each other and power their operations, and to get students involved in the industry.