ARTICLES BY LOUIS

• Stealth CDMO Reveals Secrets Of The Cell-Therapy Industry

  12/4/2023

  For months, kept under stealth mode was an emerging cell-therapy company’s plans to spin out its development and manufacturing facility as a CDMO. No, not a stealth biotech. A stealth CDMO. Part 1 of an intriguing investigation.

• Quality And Regulatory Professionals Joined At The Hip

  11/27/2023

  The context and scope of what quality, regulatory, and technical teams – CMC development professionals – need to accomplish has changed dramatically.  It’s a different paradigm, and when you add a CDMO to the mix, it's a very interesting conversation. 

• A Cell Therapy Company’s “Unpopular” Internal Manufacturing

  11/20/2023

  “As unpopular as this may be with your readership ... I think it's important to own, control, have complete oversight and a seamless process at an internal manufacturing facility with your own team.” No worries about being controversial, CEO Brian Culley. Please go on.                                                     

• Lineage Cell Therapeutics Manufactures Internally – Should You?

  11/16/2023

  Is this an example of a therapy developer with “platform technology” ostensibly pursuing its own pipeline, but also offering services as a contract manufacturer? Lineage CEO Brian Culley says no. He has a different model in mind.

• Which States Are Best To Locate Your Biotech?

  11/13/2023

  How would you go about looking for a modest-sized facility in the U.S. to establish your own development and clinical-stage manufacturing platform? How might a CDMO go about it today? We started this path of inquiry in our previous editorial. Today, the actual tour. 

• Indian CDMO Brings Continuous Manufacturing To New Jersey

  11/6/2023

  An India-based CDMO sets up shop in New Jersey to establish continuous manufacturing (CM) operations to target biologics customers in the U.S.  How did this deal materialize? What's it say about our industry?  An intriguing backstory.

• What A Process Chemist Learned At CDMOs

  11/1/2023

  “What’s interesting about being at a CDMO,” says Matthew Johnson, “is as much as you learn about your own organization, you get unique insights into the various biotechs and pharma companies relying on you. I learned to look for how they operated internally, but also if they understood our concerns as well.”

• “Organizational Outsourcing” At Astex Pharmaceuticals

  10/30/2023

  After decades working at CDMOs, Matthew Johnson decided to give it a go directly pushing along NCEs at a biopharma. The company he selected for this new endeavor has an interesting organizational matrix – components of an international, external-internal supply chain.

• Oh, Oligonucleotides! Everybody Wants In

  10/23/2023

  “We’re working on oligonucleotides,” says the bubbling biotech. “We can do oligos!” cries the eager CDMO. So it’s a deal? Hang on, says Tony Sampognaro, Director, CMC Project Management, at oligo-focused Stoke Therapeutics.

• Outsourcing Needs More MBAs (Yes, You Read That Correctly)

  10/16/2023

  Tony Sampognaro of Stoke Therapeutics recently received his MBA. He thinks many others in our industry should do so as well. He believes its what we need to outsource more efficiently, and work better with CDMOs.