The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.
News|Articles|June 30, 2005
FDA Posts Q5E Biotech and Biological Products Comparability Guideline
FDA Posts Q5E Biotech and Biological Products Comparability Guideline
Advertisement
The US Food and Drug Administration (Rockville, MD,
According to the document, Q5E details FDA’s current thinking and recommendations about assessing “the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product” during development and after approval. The guideline was written to assist manufacturers in providing evidence to ensure that such process changes will not adversely affect the quality, safety, or efficacy of the product.
–Maribel Rios
Advertisement
Related to this article
Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.
Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
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.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Advertisement
Advertisement