BioPharm International January 2018

January 2018 | Volume 31, Issue 1
BioPharm International January 2018 Issue
Cover Story
Scientific advances and renewed investment may infuse biopharma for growth.
Features
Open standards based on GAMP and GS1 will soon be released and more companies are moving beyond basic compliance.
Gene therapies highlight FDA new drug approvals in 2017.
Advances in TFF and single-use systems help advance UF/DF on the continuous processing path.
Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.
Recent investments show expansion activity in cell culture facilities.
Proper selection and installation optimizes fluid system performance.
Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
New technological advancements seek to improve pharmaceutical process monitoring and control.
Peer-Reviewed Research
The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).
Regulatory Beat
Policy makers look to boost generic drugs, curb opioid abuse, and maintain incentives for innovation.
Perspectives on Outsourcing
The industry will see an impact from financing, M&As, advanced therapies, generic drugs, and the retail market in 2018.
Ask the Expert
Enterprise-wide processes, procedures, and systems are the keys to data integrity and peace of mind, according to Siegfried Schmitt, PhD, principal consultant at PAREXEL.
From the Editor
BioPharm International will mark 30 years of biopharma industry progress and challenges in 2018.
Product Spotlight
By BioPharm International Editors
The Wilden Quattroflow QF10k size pump from PSG, a Dover company, has been designed to fill the gap between the existing QF4400/5050 and QF20k pump sizes.
By BioPharm International Editors
Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.
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