Search results for "bioprocess" in Articles / App Notes
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
Article
The Development and Application of a Monoclonal Antibody Purification Platform
…D, is an associate research fellow, all at Pfizer Global Research and Development Global Biologics, Bioprocess R&D, Chesterfield, MO, 636.247.6519 , [email protected]
References
1. Fa…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
BioProcess Int. 2004;2:42–52.
6. Swann PG, Tolnay M, Muthukkumar S, Shapiro MA, Rellahan BL, Clouse KA. Considerations for the development of therapeutic monoclonal antibodies. Curr Opin Immunol. …
Article
Welcome to the new Process Development Forum
August 15, 2013
Welcome to the new Bioprocess Development Forum (PDF) website.
We launched www.ProcessDevelopmentForum.com two years ago as a new channel for information relevant to research…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Clinton Weber is associate director of BioProcess Sciences, Ashok Kumar is principal scientist, Lisa Joslin is process validation manager, and Roland Ashton, James Schmid, and Michael Larson are devel…
Article
Flexibility in Biopharmaceutical Manufacturing
The history of bioprocessing drug substances has been such that mono-facilities were built to produce large volumes of single blockbuster products. The business environment has changed and biofaciliti…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
BioProcess Int 24:30-38 (2011)
4. Application Note: Scale-up of adherent Vero cells grown on Cytodex microcarriers
using ReadyToProcess equipment, Cytiva, 29-0435-48, Edition AA (2013)
5. …
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Howard Levine, President and Principal Consultant of BioProcess Technology Consultants, about what these guidelines mean for developers of biosimilars. Dr. Levine is based in Woburn, Massachusetts, in…
Article
PDA's Technical Report for Biotech Cleaning Validation
DEGRADATION EFFECTS
A key consideration in bioprocessing is that the active ingredient is usually degraded by cleaning processes that involve hot, aqueous, alkaline cleaning solutions. Although th…