Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|September 3, 2020
Manufacturing Biopharmaceuticals from Start-up to Commercialization
Author(s)PDA
This ebooklet walks through the steps required to take a biologic/biopharmaceutical product forward to commercial manufacturing. It distinguishes between a drug and biologic, which is key to understanding the complex requirements for biologics development and manufacture.
Related to this article
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
Jane Zhang of ETCH Sourcing explains why geopolitics, transparency, and partnership now weigh as heavily as cost and quality when companies choose suppliers, in this episode of Ask the Expert, moderated by Susan J. Schniepp of Nelson Labs.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
Ravi Kiran Kaja, PhD, USP, explains what harmonization of extractables and leachables standards looks like in practice.
Jaenisch, Muraru, and Pandey discuss new skills for QC and regulatory teams, plus patient trust, as new approach methodologies reshape pharma.
Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
OpenAI acquired Orchestra Bio to pair AI agents that track drug development timelines with its Rosalind life sciences tools, raising oversight questions for pharma teams.
Trending on Pharmaceutical Technology
1
OpenAI Bets on Accelerating Drug Development Timelines With Orchestra Bio
2
AAPS PharmSci 360 2026: System Suitability Standards in E&L Testing
3
FDA Approves Bepirovirsen: Why Oligonucleotide CDMOs Should Take Note
4
Nitrosamine Problems and Industry Solutions: PharmTech Explained
5