|
|
|
|
|
|
|
|
|
Webinar: Efficient CDMO To CDMO Program Tech Transfer
|
Tech transfer can make or break the path from development to scalable manufacturing. In this presentation, Andelyn Biosciences explores how early alignment on process readiness, analytical strategy, and governance can reduce execution risk. Discover how transparent milestones and evidence-based decision-making help teams navigate tech transfer with confidence and ensure life-changing therapies reach patients reliably, consistently, and at scale. Click here to learn more.
|
|
|
|
|
|
|
|
|
|
From Tactical Response To Strategic Discipline
|
|
White Paper | Thermo Fisher Scientific
|
Historically managed through late-stage adjustments, operational adaptability has become a strategic imperative to prevent programs from stalling under real-world pressures.
|
|
|
|
|
|
|
|
|
|
By Louis Garguilo, chief editor, Outsourced Pharma
|
The FDA informed us again in April the Bloomington, Indiana, facilities owned by Catalent until sold to Novo Nordisk in December 2024, has not solved quality issues. This adds to an FDA inspection/poor response and remediation history years long in the making. How is it we are witnessing this at a U.S. facility run by a name-brand CDMO and then Big Pharma? Catalent, for its part, wants to stop "inaccuracies in media coverage." Here's analysis from an experienced pharma professional and our own Chief Editor Louis Garguilo.
|
|
|
|
|
|
How To Avoid The CDMO Selection Trap
|
|
By Louis Garguilo, chief editor, Outsourced Pharma
|
Chief Editor Louis Garguilo is concerned about how drug sponsors evaluate external partners. "Beware the selection of CDMOs for factors over fundamentals," he writes in his latest editorial. This injunction warns against getting entangled in a spreadsheet of details when choosing a CDMO. It’s a difficult task. We continue to add factors we deem as crucial to the selection process, and thus have arrived at the point where we actually talk ourselves out of opting for the best CDMO for our needs.
|
|
|
|
Reviving Shelved Orphan Drug Programs
|
|
A conversation between Elizabeth White of the Orphan Therapeutics Accelerator and Life Science Connect's Jon O'Connell
|
The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.
|
|
|
|
INDUSTRY INSIGHTS CONTINUED
|
|
|
|
|
|
|
|
|
|
Lipid Nanoparticles For Pulmonary Delivery Of mRNA
|
|
Poster | By Sams M. A. Sadat, Vicente Lacap, Richard Jiang, et al., Cytiva
|
Gain insight into how nebulized mRNA lipid nanoparticles show preclinical success in lung delivery, offering fresh momentum for inhaled gene therapies targeting respiratory diseases.
|
|
|
|
|
|
|
|
|
|
Challenges And Opportunities With Novel AAV Capsids
|
|
Webinar | Viralgen
|
Explore challenges and solutions in developing novel AAV capsids, focusing on manufacturing complexity, analytical testing, and regulatory considerations for advancing gene therapy effectiveness.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OUTSOURCED PHARMA CAPABILITIES UPDATE
|
|
|
|
|
CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.
|
|
|
| Connect With Outsourced Pharma: |
|
|
|
|
