Search results for " validation" in Articles / App Notes
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Iss…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Jun 15, 2015
By Agnes Shanley
BioPharm International eBooks
Volume 28, Issue 13
Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, c…
Article
A Bright Future for the Plasma Fractionation Industry
Christophe Carnewal presented their work on qualified small-scale models to reduce the number of conformance batches and a simplified regulatory submission for upscaling and process validation activit…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
…e identical in different locations, which again simplifies maintenance, documentation, training, and validation. “The modular nature of machinery makes modifying or adding options possible; their plu…
Article
Biomanufacturing Outsourcing Globalization Continues
opened its Life Sciences Centre of Excellence in Shanghai, which offers biopharma process solutions (CMO work), technical, and validation support as well as training (5).
Beyond China and India, L…
Article
Ensuring the Quality of Biologicals
standards have a role during the development of biosimilars as they are used for method qualification and validation. Where biosimilars have been approved for use in the European Union, there are corr…
Article
Modular Manufacturing Platforms for Biologics
…h a pod is replicated, we would always recommend to clone the system to reduce the qualification and validation burden.”
Current modular facilities
While there are numerous examples of facili…
Article
Continuous Chromatography: Trends, Definitions and Approaches
Process Development Forum speaks with Karol Lacki, Customer Collaborations Leader at Cytiva, about continuous chromatography.
There is a lot of attention being paid to continuous chromat…
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
Vaccine Development and Production Challenges Manufacturers
Mar 01, 2015
By Jill Wechsler
BioPharm International
Volume 3, Issue 28
Vaccines are front-page news these days. Researchers are advancing new vaccines for Ebola and other devastating di…