Search results for " 2015"
Article
Lessons Learned Accelerate Vaccine Development
Tech transfer from Leiden occurred at the end of 2014, and by January 2015, the first GMP batch was run in the 2 x 10-L scale pilot plant at Bern. The dedicated facility was completed in the third qua…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
22, 2015.
23. D.W. LaFleur et al., mAbs 5 (2), pp. 208-18 (2013).
24. P.A. Moore et al., Blood 117 (17), pp. 4542-4551 (2011).
25. T. Kitazawa et al., N…
Article
The Metrics of Quality Culture
Schniepp
The long awaited, anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July 28, 2015. The official title of this guidance for industry is Request f…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
9-14 (January/February 2015).
2. A. Beck et al., Nature Rev. Immunol. 10, pp. 345-352 (May 2010).
3. Cytiva, “Optimization of dynamic binding capacity and aggregate clearance in a monoclonal a…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
During an inspection of a dedicated manufacturing facility, conducted by the Italian Medicines Agency, Agenzia Italiana del Farmaco AIFA in 2015, it was observed that no validation studies were perfor…
Article
Using Single-Use Technologies in Downstream Processing
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Issue 7, pg 24–26
The use of single-use systems (SUS) in biopharmaceutical manufacturing has been steadily increasing. W…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Issue 7, pg 34–36
BioPharm International spoke with Stephan Krause, director of quality assurance, Laura Jeannel, asso…
Article
Host-Cell Protein Measurement and Control
Shameem, “Host-Cell Protein Measurement and Control” BioPharm International 28 (6) 2015.
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
A senate bill introduced in late April 2015 will make it more difficult for so-called “patent trolls,” to bring patent suits to court, as the new bill seeks to force the losing party to pay legal fees…