This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
News|Articles|August 1, 2019
Bringing Gene Therapies to Market
Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.
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The approval of the first gene therapies and technology advances have spurred research and investment for new treatments and provided hope for patients. Researchers are now talking about “cures” versus “treatments,” says Eric Langer, managing partner, BioPlan Associates, in an interview with BioPharm International. Turning clinical processes into an operational process will prove challenging.
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Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
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