The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
News|Articles|January 24, 2024
Process Optimization for mAb Commercial Manufacturing
Author(s)Catalent Pharma Solutions
It is essential to have access to the right tools and expertise to support process development for biologic therapies, from the clinical trial phase to commercialization.
Related to this article
Jaenisch, Muraru, and Pandey debate whether AI "slop" is infiltrating pharma SOPs and deviation reports and who should catch it first.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Christy Owings, Thermo Fisher, explains clinical trial supply chain risks in Latin America, importer-of-record strategy, AI, and eCOA delays.
PharmTech AI Pulse Check debuts: pharma experts tackle GxP 'slop,' multi-agent validation risk, OCR document mining, personalized mRNA cancer therapy.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
Trending on Pharmaceutical Technology
1
The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push
2
Inluriyo-Verzenio Combo Doubles PFS, Adds Oral Complexity
3
Can AI Agents Satisfy CGMP Documentation Requirements?
4
CPHI Milan Brings Back Leadership Summit as Supply Chain and Manufacturing Pressures Ramp Up
5