This article explains the 4 shifts enabling faster, lower-risk, commercially successful biologics technology transfer.
News|Articles|March 2, 2005
- Pharmaceutical Technology-03-02-2005
- Volume 29
- Issue 3
Optimism Taking Over in Pharmaceutical Chemicals
Author(s)Jim Miller
After a five-year downturn, cautious optimism is taking hold among API manufacturers.
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Appraisal of the Laser Diffraction Particle-Sizing Techniqueover 21 years ago
In the Spotlight - March 2005over 21 years ago
A “Disclosure Defense” in Liability Lawover 21 years ago
Managing Aseptic Interventionsover 21 years ago
Validating Automated Systemsover 21 years ago
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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.
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.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into pharmaceutical development.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
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