BioPharm International
February 01, 2017
Downstream Processing
30
2
Although Protein A remains a top technology for monoclonal antibody purification, the industry continues to look for new approaches to improve conventional capture chromatography.
February 01, 2017
Upstream Processing
30
2
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
February 01, 2017
Manufacturing
30
2
Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.
February 01, 2017
Manufacturing
30
2
To prevent failure during lengthy use, tube life should be monitored and a preventive maintenance program enacted.
February 01, 2017
Cover Story
30
2
Despite limitations, mass spec is having an impact on biologic drug development and manufacturing.
February 01, 2017
From the Editor
30
2
Reducing regulatory roadblocks requires more than the stroke of a pen.
February 01, 2017
Features
30
2
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
February 01, 2017
Ask the Expert
30
2
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
February 01, 2017
Regulatory Beat
30
2
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
February 01, 2017
Perspectives on Outsourcing
30
2
The outlook for the CMO and CDMO industry may be affected by ever-changing politics.
February 01, 2017
Peer-Reviewed Research
30
2
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.
February 01, 2017
Supply Chain
30
2
Longer packouts are becoming the rule, as logistics service providers and sponsors gain experience planning logistics for clinical trials involving cell and gene therapies.
February 01, 2017
Issue PDF
30
2
Click the title above to open the BioPharm International February 2017 issue in an interactive PDF format.