ARTICLES BY LOUIS

• The Mighty CDMOs Producing API

  7/14/2025

  CDMO focused on active pharmaceutical ingredients (APIs) have long been vital components in the supply chain. Today, they are more than your enablers. CDMO have become strategic actors helping to reshape global outsourcing markets. A new report focuses on the new forces raising their importance.

• The FDA Was Darned Near Perfect, Right?

  7/11/2025

  Let's return to minutes before Donald Trump became president in January, to a time when the FDA was near perfect. That’s what one would assume today listening to those up in arms over the agency. Of course, the reality was quite different. Chief Editor Louis Garguilo helps regain perspective.

• Why CDMOs Are Leaving Small Molecules Behind

  7/7/2025

  It’s rare when a CDMO’s restructuring leads to thoughts about national health policy. But as Chief Editor Louis Garguilo wrote his recent editorial on Lonza’s decision to focus heavily on biologics, it brought to mind a government policy that may have contributed to the company’s restructuring. No, it's not tariffs.

• RNAi vs. mRNA: Two Therapies, Two CDMO Strategies

  7/1/2025

  The biotech industry is often described in grand dichotomies such as innovator vs. generic, small vs. large molecule, or clinical vs. commercial. These differentiators influence development and manufacturing, CDMO selection and outsourcing strategies. There are also nuanced pairings, such as mRNA vs. RNAi.

• Lonza Bets On Biologics. What's It Mean For You?

  6/26/2025

  It’s a large and universally recognizable CDMO, so this matters. Swiss-based powerhouse Lonza will increase its focus on biologics, and “advanced synthesis” including for antibody-drug conjugates (ADCs), cell and gene therapies (CGT), and mRNA therapeutics. Will other CDMOs follow suit? What's this say about the future of development outsourcing and our industry? 

• Late-Stage Formulation Is A Different Ballgame. Insights From An Allstar

  6/19/2025

  The art and science of late-stage/commercial formulation, compared to early-phase formulation, is a different ballgame, says Dileep Boinipally, currently utilizing CDMOs to advance a pipeline of oral and injectable candidates. He has a stadium full of advice for readers.

• How A Biotech Navigates the CDMO Frenzy For GLP-1 Services

  6/17/2025

  Doug Bakan enjoys all the attention CDMOs give him nowadays at his biotech with GLP-1-related programs. But how is he selecting his external partners? Which are most trustworthy? Can he discern what they say is what they they're going to do? Here are his thoughts.

• Early-Phase Formulation Done Right: An Expert Analysis

  6/12/2025

  Dileep Boinipally has extensive experience in formulation, manufacturing process development, and regulatory strategy. He’s adept at explaining all that, but Chief Editor Louis Garguilo got him to focus for readers on the ins-and-outs of the practice of early formulation development.

• Billions Of Dollars In CDMO Secondary Packaging Of Biologics

  6/10/2025

  Chief Editor Louis Garguilo analyzes a report projecting the biologics CDMO secondary packaging market could rise from $2.59 billion this year to USD $5.50 billion by 2034. Projecting so far into the future is tricky business, but Garguilo explains the ultimate value.

• A Psychedelic Path To CDMO Selection?

  6/5/2025

  "Be prepared. Structured. Work in a systematic fashion towards your CDMO selection." That's a rather non-psychedelic paraphrasing of Anthony Grenier, Reunion Neuroscience, a biotech pursuing the development of novel, synthetic psychedelic molecules. Here's more of his thoughts on CDMO selection.