Search results for " mAbs" in Articles / App Notes
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
What Drove Biopharma Development in 2014?
Process Development Forum (PDF) featured a myriad of topics at the forefront of biopharmaceutical development. But some issues stood out as garnering the most attention from readers in 2014. One of …
Article
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitio…
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
Article
ReadyToProcess WAVE 25 Bioreactor System
The single-use ReadyToProcess WAVE 25 bioreactor system is a reliable and intuitive cell culture device for working volumes up to 25 L.
The system is based on a well-known rocking technology tha…
Article
Stirring up the fermentation game
Microbial fermentation in single-use Xcellerex™ XDR-50 MO fermentor system
This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in culti…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…