Search results for " 2015"

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Patenting Prospects for Cell-Based Therapies
Cell-based therapies are moving medical treatments forward, but intellectual property uncertainties may delay progress. By Kevin Noonan Treatment using cell-based therapies is a rapidl…

Article Managing Residual Impurities During Downstream Processing
1, 2015 and ultimately issued on April 1, 2016. This document is aimed at providing industry guidance on the best analytical approach for HCP quantitation. It incorporates choice of method; aspects of…

Article Speed and Flexibility Are Dual Goals for Biopharma Operations
In a draft guidance for industry, Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base (December 2015), the agency outlined a process for biopharmaceutica…

Article Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
17, 2015).

Article Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…

Article Process Chromatography Selection for Downstream Processing Applications
Haigney, BioPharm International 28 (11) 2015. 2. Tao et al., Biotechnol. Bioeng. online, DOI: 10.1002/bit.25192

Article Downstream Processing Continues to Worry CMOs
CMOs are working hard to improve performance by investigating new technologies for filtration and purification. By Eric S. Langer Downstream processing continues to be a significant pain poi…

Article Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality. B…

Article Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods. By Cynthia A. Challener Effective microbiological testing during biopharmace…

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