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.
News|Articles|January 29, 2024
Alternative buffer management strategies to achieve downstream process improvements
Author(s)Avantor
Buffers are used in great quantities when producing monoclonal antibodies (mAbs), and many biopharmaceutical companies — even large ones — do not have the processing capacity or infrastructure in-house to handle these large volumes. Whether it’s providing quality, pre-weighed, GMP-compliant raw materials or the entire buffer preparation step, there are options available to optimize your process.
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
Nitrosamine Problems and Industry Solutions: PharmTech Explained
3
AAPS PharmSci 360 2026: System Suitability Standards in E&L Testing
4
FDA Approves Bepirovirsen: Why Oligonucleotide CDMOs Should Take Note
5