Search results for " separation" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Biomanufacturing Outsourcing Globalization Continues
May 02, 2015
By Eric S. Langer
BioPharm International
Volume 28, Issue 5
Biopharmaceutical manufacturing clusters continue to emerge outside of the traditional hubs of North America …
Article
Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 4
Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …
Article
USP Publishes Monoclonal Antibody Guidelines
This chapter includes purity assessments by chromatographic separation of size variants and capillary sodium dodecyl sulfate (CE–SDS) electrophoresis. In addition, it includes procedures for analysis …
Article
Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The authors review efforts to limit polymer degradation without significantly impeding cell growth.
Jan 01, 2015
By Sara Ullsten, Shujian Yi, Jeffrey Carter, Eva Lindskog, Pokon Ganguli, Her…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
Antibody N-glycosylated forms were analyzed by PNGase F digestion, reductive amination labeling, followed by separation using ultra-performance liquid chromatography (UPLC).
In a qPCR array, 3 …