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BioPharm International-02-01-2017
BioPharm International
mAb Purification: Rethinking the Initial Capture Step
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.
Ensuring the Biological Integrity of Raw Materials
February 01, 2017
Upstream Processing
30
2
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
Pumping Fluids in Biopharmaceutical Processing
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.
Preventive Maintenance of Single-Use Tubing for Peristaltic Pumps
February 01, 2017
Manufacturing
30
2
To prevent failure during lengthy use, tube life should be monitored and a preventive maintenance program enacted.
Mass Spectrometry Measures Up to Analytical Challenges
February 01, 2017
Cover Story
30
2
Despite limitations, mass spec is having an impact on biologic drug development and manufacturing.
Regulatory Reform Is Not That Simple
February 01, 2017
From the Editor
30
2
Reducing regulatory roadblocks requires more than the stroke of a pen.
Evaluating E&L Studies for Single-Use Systems
February 01, 2017
Features
30
2
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
Ensuring Sterility in Small-Scale Production
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.
User Fees Needed to Help FDA Manage its Full Plate
February 01, 2017
Regulatory Beat
30
2
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
Viewpoint: Challenges and Opportunities for CDMOs
February 01, 2017
Perspectives on Outsourcing
30
2
The outlook for the CMO and CDMO industry may be affected by ever-changing politics.
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
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.
Cold Chain: Zeroing in on the Last Mile
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.
BioPharm International, February 2017 Issue (PDF)
February 01, 2017
Issue PDF
30
2
Click the title above to open the BioPharm International February 2017 issue in an interactive PDF format.