Search results for "antibody"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
FDA, Memorandum: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (Rockville, MD, Feb. 28, 1997).
12. ICH, Q9 Quality Risk Management (Ro…
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Will the facility be manufacturing monoclonal antibodies, recombinant proteins, vaccines, antibody-drug conjugates, or fragment antibodies? Also, will the products be mammalian cell-derived or microbi…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Data were available for 15 measurements over 16 time points for 20 cultures (19 Chinese hamster ovary cell lines) making the same recombinant monoclonal antibody (mAb) giving a 240-dimensional data se…
Article
E. coli growth and Dab expression in single-use and stainless steel fermentors
coli domain antibody (Dab) production process developed for a stainless steel fermentor. Cell growth,
cell density, and Dab expression levels were assessed and compared between the two production…
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
I am also convinced that HIC will be a useful tool for purification of some of the new types of biomolecules, such as antibody drug conjugates (ADC). I am aware that HIC is being considered complex. F…
Article
A Bright Future for the Plasma Fractionation Industry
One example being the announcement from Chugai/Roche in November about the results from studies on “ACE910,” an anti-factor IXa/X humanized bispecific antibody.
The third and final day of the co…
Poster
Optimizing dynamic binding capacity and aggregate clearance in an mAb polishing step
Capto™ S ImpAct is a strong cation exchange (CIEX) chromatography medium (resin) designed for monoclonal antibody (MAb) polishing steps. In this study, optimization of binding conditions targeting h…
Article
SEC in the Modern Downstream Purification Process
While SEC may have mostly been abandoned in monoclonal antibody (mAb) and other protein purifications, it is still commonly used in the purification of viruses and plasmids.
SEC, also known as gel…
Article
FDA Approves First Biosimilar
Mar 06, 2015
By Randi Hernandez
BioPharm International
FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…
Article
Fermentation for the Future
Newer drug substances, such as single-domain antibodies, peptibodies, or antibody fragments that contain the effective domains, have recently been produced using microbes.
Microbial expression is …