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Minimizing Regulatory Risk For Biologics Manufacturing Changes
42+ min ago (182+ words) Guest Column | April 29, 2026 By Megha Sinha, founder and CEO, Kamet Consulting Group Post-approval change management for biologics presents a very different challenge from that of manufacturers of small molecules. Here, it is not typically an issue of volume (a biologic…...
AES Cleanroom Technology appoints John Groth As Chief Revenue Officer
1+ day, 12+ hour ago (313+ words) News | April 27, 2026 Montgomeryville, PA - AES Cleanroom Technology, a leading provider of modular cleanroom design, manufacturing, and construction solutions for the life sciences and biopharmaceutical industries, has appointed John Groth as Chief Revenue Officer as demand grows for flexible, high-performance manufacturing…...
Quality By Design Understanding And Securing Virus Clearance
2+ day, 5+ hour ago (180+ words) Bioprocess Online Quality By Design Understanding And Securing Virus Clearance Virus clearance remains one of the most critical " and resource-intensive " elements of biopharmaceutical process development. Applying Quality by Design principles enables a shift away from conservative worst'case testing toward data'driven,…...
Using Client Centricity As Fuel For Innovative Biologics Development And Manufacturing Solutions
2+ day, 16+ hour ago (240+ words) Bioprocess Online Using Client Centricity As Fuel For Innovative Biologics Development And Manufacturing Solutions By Dr. Marvin Kadisch, Senior Director Process Science Upstream, Dr. Martin Pannek, Director Analytical Science, Dr. Alina Handl, Process Manager Upstream, Dr. -Ing. Marc Hein, Process…...
Unique Products, Unique Solutions: Why Flexible, Tailored CDMO Support Is A Non-Negotiable In Sterile Fill-Finish
5+ day, 10+ hour ago (212+ words) Unique Products Unique Solutions Why Flexible Tailored CDMO Support Is A Non-Negotiable In Sterile Fill-Finish'Bioprocess Online Unique Products, Unique Solutions: Why Flexible, Tailored CDMO Support Is A Non-Negotiable In Sterile Fill-Finish As sterile injectable pipelines grow more complex, fill-finish has…...
How AI Could Clear Logistics Roadblocks Limiting Patient Access To CGT
6+ day, 1+ hour ago (1280+ words) Guest Column | April 23, 2026 By Arnaud Deladeriere, Ph. D. , Cell&Gene Consulting Inc. The prevailing logic around delivering ATMPs to more patients can be summed up as a cost issue. When a promising new cell therapy hits the market, big price stickers…...
Do Changes Signal The End Of Biosimilar Regulatory Redundancy?
6+ day, 1+ hour ago (285+ words) Guest Column | April 23, 2026 By Partha Anbil, MIT Sloan Life Sciences Industry Advisor A revolution in biosimilar market dynamics promises to reshape competition and pricing for biologic therapies " a domain initially excluded from generic-style abbreviated pathways. The EMA declared all biosimilars…...
FDA's First c GMP Enforcement Action On AI Misuse In Drug Manufacturing
6+ day, 13+ hour ago (321+ words) Guest Column | April 22, 2026 By Kishore Hotha, Ph. D. , MBA, president, Dr. Hotha's Life Sciences LLC The quote that should keep you up at night: "The AI never told us it was required." That was a drug manufacturer's response to FDA investigators…...
Expanding The IV " SC Framework: What Reformulation Really Means
1+ week, 1+ hour ago (1630+ words) Guest Column | April 22, 2026 By Monika Sharma, fractional CMC & program leader, CDO, EOSPA LLC In Article 1, I made a simple point: IV "SC is not a formulation problem or a device problem. It is a system design decision. Here, I will…...
Validating Candel's BLA-Ready Analytics Profile
1+ week, 1+ hour ago (439+ words) Guest Column | April 22, 2026 A conversation with Seshu Tyagarajan of Candel Therapeutics and Life Science Connect's Jon O'Connell In Part 1 of this interview, Candel leadership discussed their CDMO partnership strategy, tech transfer experience, and supply chain readiness ahead of a planned…...