BioPharm International
May 01, 2016
Peer-Reviewed Research
29
5
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
May 01, 2016
Troubleshooting
29
5
Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.
May 01, 2016
Product Spotlight
29
5
The FlexPro 50, from Groninger, is a modular filling and closing system designed to process vials, cartridges, and syringes, as well as vials in bulk and trays.
May 01, 2016
Product Spotlight
29
5
The Optima AUC from Beckman Coulter Life Sciences is an ultracentrifuge that determines molecular weight, size shape, and polydispersity.
May 01, 2016
Perspectives on Outsourcing
29
5
Growth may be slowing, but outsourcing activity remains healthy.
May 01, 2016
Ask the Expert
29
5
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
May 01, 2016
Guest Editorial
29
5
Policies for patient access to life-saving therapies must keep pace with biomedical innovation.
May 01, 2016
Cover Story
29
5
Early successes drive the need to overcome safety issues, increase efficacy, and address manufacturing challenges.
May 01, 2016
Cover Story
29
5
Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.
May 01, 2016
Cover Story
29
5
Two main safety issues have been identified in the early-phase clinical trials conducted to date for chimeric antigen receptor (CAR)-T cell therapies.
May 01, 2016
Cover Story
29
5
Cell therapy companies are attracting interest from investors, and drug companies are seeking partnerships and acquistions to accelerate development.
May 01, 2016
Features
29
5
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk mitigation.
May 01, 2016
Issue PDF
29
5
Click the title above to open the BioPharm International May 2016 issue in an interactive PDF format.
April 01, 2016
Regulatory Beat
29
5
The campaign against opioid abuse opens door to more innovative therapies.
March 01, 2016
Features
29
5
The authors provide their perspectives on shipping validation.