Search results for " comparability" in Articles / App Notes
Article
Reporting Quality Metrics to FDA
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
By Siegfried Schmitt
Q: We are a contract manufacturing organization (CMO), sp…
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
Article
Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
By Anurag S. Rathore, Jyot…
Article
Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
By Cynthia A. Challener
Biopharmaceutical manufacturing involves a series o…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
Fed-batch supplements to boost cell culture performance
To increase the yield of a target protein, fed-batch culture is often employed in biomanufacturing processes. This application note demonstrates the enhanced performance of commonly used cell lines …
Article
Biacore Concentration and Ligand-Binding Analyses
Biotherapeutic drugs including antibodies, cytokines, and hormones are used for treatment of a variety of diseases including arthritis, cancer, and diabetes. Compared to traditional small-molecule dru…
Article
Capto™ Core 700 in Vaccine Processing
The aim with this white paper is to discuss the advantages of using Capto Core 700 in virus purification compared to size exclusion chromatography (SEC), a technique commonly used in several vaccine…
Article
Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International
Humans represent the greatest risk for microbial contamination in an aseptic process.
Aseptic processing has garnered some increased scrutiny…
Article
Breakthrough Drugs Raise Development and Production Challenges
…diness for pre-approval inspection, deferral of Phase III studies to post approval, and the need for comparability protocols to facilitate postapproval changes. Communication with FDA is important th…