Search results for " protein"
Article
GMP Challenges for Advanced Therapy Medicinal Products
56: Application of Phase-Appropriate Quality Systems and CGMP for the Development of Therapeutic Protein Drug Substance (Bethesda, US, 2012).
About the author:
Sean Milmo is a freelance write…
Article
Best Practices in Qualification of Single-Use Systems
Culter, Protein Purification Protocols, Second Edition (Humana Press, 2004).
14. F. Jameel and S. Hershenson, Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals (W…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Considerations such as membrane porosity, charge, or protein binding may also influence the selection process.
Hutchinson: Undoubtedly, understanding the organisms endemic within the facility play…
Poster
Purification platform challenges and strategies for handling of "tricky" MAbs
In the work presented here, capture using high-capacity protein A medium (resin) was followed by polishing using a novel cation exchange chromatography medium.
Poster
Three-step monoclonal antibody purification processes using modern chromatography media
This application note describes monoclonal antibody (MAb) purification processes using the expanded mAb purification toolbox of Cytiva business, covering modern chromatography media (resins) for sta…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
This structure replaces specific divisions for monoclonal antibodies and for other proteins staffed by more specialized reviewers. The change should help OBP manage its workload more effectively as bi…
Article
USP Publishes Monoclonal Antibody Guidelines
… other related molecules, such as IgM or other isotype antibodies, antibody fragments, and Fc-fusion proteins. When the active substance is a conjugated antibody, such tests can be performed on the p…
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…
Article
FDA Approves First Biosimilar
In fact, FDA said in a briefing earlier this year that six batches of the EU-approved Neupogen used in the Zarxio clinical trials were “lower in protein content than the comparator products and do not…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
“High-throughput, kinetic assessment of target binding on cells for those targets that cannot be produced as soluble proteins remains a challenge for the industry,” she observes. Several companies are…