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BioPharm International-05-01-2016
BioPharm International
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
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.
Using Single-Use Systems in Aseptic Fill-Finish
May 01, 2016
Troubleshooting
29
5
Material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill-finish system.
Filling and Closing System Reduces Decontamination Cycle
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.
Ultracentrifuge Allows for Multi-Wavelength Analysis
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.
Outsourcing of Biomanufacturing in 2016
May 01, 2016
Perspectives on Outsourcing
29
5
Growth may be slowing, but outsourcing activity remains healthy.
Reporting Quality Metrics to FDA
May 01, 2016
Ask the Expert
29
5
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
The Value of Saving Lives
May 01, 2016
Guest Editorial
29
5
Policies for patient access to life-saving therapies must keep pace with biomedical innovation.
Realizing the Potential of CAR-T Cell Therapies
May 01, 2016
Cover Story
29
5
Early successes drive the need to overcome safety issues, increase efficacy, and address manufacturing challenges.
Role of contract manufacturing in cell therapy development and manufacturing
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.
Advancing cell therapy safety
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.
Cell therapy growth and pains: Investment, collaboration, and controversy
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.
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
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.
BioPharm International, May 2016 Issue (PDF)
May 01, 2016
Issue PDF
29
5
Click the title above to open the BioPharm International May 2016 issue in an interactive PDF format.
FDA and Manufacturers Seek Safer Pain Medications
April 01, 2016
Regulatory Beat
29
5
The campaign against opioid abuse opens door to more innovative therapies.
Qualification and Validation of Single-Use Shipping Systems
March 01, 2016
Features
29
5
The authors provide their perspectives on shipping validation.