ARTICLES BY LOUIS

• Essentially Free: How A Definition Tamed The Visible Particulate Matter Debate

  In 2005, Stephen Langille was the FDA liaison to the USP Parenteral Products - Industrial Expert Committee. He and others were concerned with the number of injectable drug product batches rejected or recalled because of  “visible particulate matter.” The situation grew worse over the years. But now Langille offers advice on how you — and your CDMOs — can prevent issues from occuring.

• Will We Learn The Right Lessons From The Coronavirus Crisis?

  What happens – or continues not to happen – next with the coronavirus is critical to the future of global pharmaceutical development and manufacturing industry’s supply chains. But what lessons will we draw from the crisis?

• The Biggest CDMO Show On Earth

  I suppose it was inevitable. After years of escalating one-upmanship in the CDMO industry, it was only a matter of time before we got the “biggest CDMO on the planet” announcement. But more details were needed. We’ve now got them for you.

• Coronavirus: Pharma To The Rescue Too Simple

  We may think we’ve been through this before with other coronaviruses such as SARS and MERS … but this time it feels different, like a larger confluence of too many overlapping and unstable tectonic plates.

• Making “No-Choice Partnerships” With CDMOs Work Out

  Still today one of the least explored dimensions of drug development and manufacturing outsourcing is the “no-choice partnership.” This might be an inherited relationship, or when unique platforms, technologies, and therapies leave few CDMOs that can actually assist. We did more exploring for you.

• Cyber Security: Are We Investing Enough In Our Supply Chains?

  Among the digital technologies that biopharma organizations can target for investment, the first choice is cyber security. But is enough of that investment steered to supply chains? And what of cyber security at CDMOs? Here’s a detailed analysis. 

• Mulkerrin On Outsourcing: Speak Softly And Carry A Good Rapport

  Michael Mulkerrin, VP, Head of CMC, ADC Therapeutics, has been a part of the biopharma industry for 35 years, the first 16 at Genentech. He’s a member of the Council of Experts, United States Pharmacopeia (USP). Recently, he offered some sage advice regarding CDMO relationships.

• Equipment You Need At Your Cell-And-Gene CDMO

  What equipment is essential at the CDMO assisting with your cell and gene therapy development and production? I’ve received some details via an investigation into Harvard’s Center for Advanced Biological Innovation and Manufacturing, and a discussion with the CEO & President of GE Healthcare Life Sciences.

• A Harvard Assist For Cell And Gene Bottlenecks

  Bottlenecks and backlogs in development and production of cell and gene therapies. Harvard to the rescue. Actually, Harvard with partners, such as companies familiar to Outsourced Pharma readers. But what will  go into the the $50 million Center for Advanced Biological Innovation and Manufacturing? We’ve got exclusive details.  

• Biopharma Outsourcing: Propelling Productivity Past 2020

  Stanley Crooke, M.D., Ph.D., founder, chairman, and CEO, Ionis Pharmaceuticals, proclaims: “Biotech has done a wonderful job of convincing Big Pharma to outsource.” James Mackay, Ph.D., founder, president, and CEO, Aristea Therapeutics, says: "Don’t call CDMOs 'service providers.'” Both CEOs are focused on biotech productivity.