ARTICLES BY LOUIS

• 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.

• Nations Should Be Able To Take Care Of Their Own

  3/10/2021

  A Biopharma and CDMO lead a positive nationalism in Canada. In fact, ‘Canada First’ hasn’t the political corollaries felt by “America First” deliberations in the U.S. Jared Davis, CEO of Providence Therapeutics, believes every country should be able to take care of their own during a health-care crises. 

• Canadian Biopharma “Enables” CDMO For mRNA Vaccine Production

  3/3/2021

  An investigation into the amazing story of how an emerging mRNA Biopharma is “enabling” the creation of a CDMO for an “all-Canada” supply chain, for COVID-19 and precision medicines.

• Uncertainty In Quality: A Primer For Emerging Biotechs

  3/1/2021

  An introduction of a quality risk-management concept – Uncertainty – specifically for emerging biopharma organizations less attuned to the intricacies of quality deliberations, from Yash Sabharwal, CEO, CherryCircle Software, and a QbDVision whitepaper titled: “Quality Risk Management: Understanding Uncertainty.”

• Supply Chain Agility: Did You Have It Last Year? What About Now?

  2/24/2021

  Who wants to revisit the challenges of 2020? Perhaps we should – and focus that retrospection on supply chain agility. Did you have it then? Do you now? In an as-it’s-happening whitepaper based on a survey and interviews, IDC chronicled the thoughts of supply chain executives during COVID disruptions.

• Analytical Development Outsourcing At “Platform” Biopharma

  2/18/2021

  A new report from the BioPhorum Development Group (BPDG) includes interesting findings on outsourcing habits for analytical development by “platform”-focused biopharmaceutical companies. Here’s what we found, and our further analysis.