FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
News|Articles|March 29, 2013
Modularization overview and implementation strategies
Craig Sandstrom, director of process engineering at Fluor discusses his presentation Modularization overview and implementation strategies, which will be part of a panel discussion, ?Getting Excited about the Modular Experience? at Interphex 2013
Advertisement
Advertisement
Related to this article
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
MASH and cardiomyopathy AI collaboration: AstraZeneca pays insitro $40M upfront for target discovery, then leads clinical development and CMC planning.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
NVIDIA’s $250M, five-year compute donation funds UK agentic AI safety research, with implications for how GMP teams validate and govern autonomous AI.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
FDA Approves Bepirovirsen: Why Oligonucleotide CDMOs Should Take Note
2
OpenAI Bets on Accelerating Drug Development Timelines With Orchestra Bio
3
AAPS PharmSci 360 2026: System Suitability Standards in E&L Testing
4
Nitrosamine Problems and Industry Solutions: PharmTech Explained
5