ARTICLES BY LOUIS

• Do You Speak ATMP-CGT-RMAT? Better Watch Your Language

  5/6/2021

  Editors and scientists should care about the words they use. That’s why it’s curious to hear U.S. biopharma pitching the European acronym "ATMP." Is this simply an acrimonious acronym argument between regulatory regions? Turns out there’s real danger lurking in our usage of these terms. 

• Standards For New Technologies: Easy Listening For Outsourcing

  4/29/2021

  We’re comforted by our music standards, those go-to playlists we can always rely on. In drug development and manufacturing, standards are also music to our ears. Now, says Ronald Piervincenzi, USP’s CEO, advanced technology needs new standards to guide the next generation of U.S.-based production of medicines.

• USP Targets Advanced Manufacturing For U.S.-Made Generics

  4/21/2021

  “What’s the USP got to do with it?” That’s what I ask Ronald Piervincenzi, CEO, U.S. Pharmacopeia. The question is triggered by the announcement of a “strategic alliance” between Phlow Technologies and the USP, and the quest to bring advanced manufacturing to our industry.

• Did The U.S. Government Just Hijack A CDMO?

  4/14/2021

  There are extenuating circumstances, but we need a deeper contemplation of what has gone on at Emergent BioSolutions regarding vaccine production. Outsourced Pharma readers are the experienced professionals to do that. So from that lens of supply-chain understanding, what’s happening here?

• Advice For Emerging Biopharma: No Stiff-Arming Your CDMO

  4/12/2021

  “With regard to the ongoing nature of a relationship with a CDMO, you need to find a partner that can align with your ambition,” says Max Donley, Aurinia Pharmaceuticals. "However," he adds, when a positive drug-sponsor/CDMO relationship starts to deteriorate, "it’s often because the CDMO gets stiff-armed.”

• Aurinia Wins FDA Approval, Gets A “Monoplant” For Commercial API

  4/8/2021

  Aurinia Pharmaceuticals and Lonza have put together a multi-year agreement for a dedicated manufacturing facility – a state-of-the-art "monoplant” – within the CDMO's existing API facility in Visp, Switzerland. So what exactly is a monoplant? And how can you get one?

• A Year Out: Time To Laud CDMOs For COVID-19 Efforts

  4/6/2021

  A biopharma executive believes the industry should receive a more complete rendering of what we’ve learned from our COVID-19 experience.His message is familiar, but isn't sufficiently elucidated: "Our drug development and manufacturing outsourcing model is integral to taming the pandemic."

• 4 Outsourcing Tips For Cell-And-Gene Therapy Developers

  3/31/2021

  Knut Niss, Chief Technology Officer, Mustang Bio, Inc., has four specific pieces of advice for Outsourced Pharma readers of all stripes, but most specifically targeted at the cell-and-gene therapy developers among you.

• Advice For Cell-Therapy Biopharma: Strategic Building, Tactical Outsourcing

  3/23/2021

  Knut Niss, Chief Technology Officer, Mustang Bio, Inc., has advice for all cell and gene developers: Build capacity now, outsource as needed later. Perhaps this changes when more CDMOs are set up to serve emerging biopharma. Here's a look.

• Outsourcing Challenges For Emerging mRNA Biopharma

  3/19/2021

  Recent mRNA vaccine successes conceal the long-term challenges emerging mRNA companies have faced with finding experience and capacity at CDMOs. Here’s sound advice for emerging mRNA when forming scientific, investment, and overall plans for commercial success.