BioPharm International February 2017

February 2017 | Volume 30, Issue 2
BioPharm International February 2017 Issue
Cover Story
Despite limitations, mass spec is having an impact on biologic drug development and manufacturing.
Features
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
Peer-Reviewed Research
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) using a small-scale model.
Manufacturing
Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.
To prevent failure during lengthy use, tube life should be monitored and a preventive maintenance program enacted.
Downstream Processing
Although Protein A remains a top technology for monoclonal antibody purification, the industry continues to look for new approaches to improve conventional capture chromatography.
Upstream Processing
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
Supply Chain
Longer packouts are becoming the rule, as logistics service providers and sponsors gain experience planning logistics for clinical trials involving cell and gene therapies.
Regulatory Beat
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
Perspectives on Outsourcing
The outlook for the CMO and CDMO industry may be affected by ever-changing politics.
Ask the Expert
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.
From the Editor
Reducing regulatory roadblocks requires more than the stroke of a pen.
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