BioPharm International, September 2012 - BioPharm International

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BioPharm International, September 2012
Features
Challenges and Opportunities for Biosimilars Developers
By Amy Ritter, PhD , Nora Barry
Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.
In-Depth Validation of Closed-Vial Technology
By Benoît Verjans , Anne Glibert , Patrick Baleriaux
The authors describe a validation master plan for closed-vial filling technology.
Regulatory Challenges in the QbD Paradigm
By Anastasia G. Lolas , Anurag S. Rathore
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
Bucking the Trend
By Pratik Jaluria
A perspective on why platform processes are not and should not define the future of bioprocess development efforts. This article is part of a special section on biopharmaceutical trends.
A Method for Removal of Endotoxin from Pharmaceutical Formulation
By Gunnar Hagelin , Lars Gøran Wistrand
The authors describe a simple method to remove endotoxins from highly viscous formulations.
A 25-Year Retrospective on Bioprocessing mAbs
By Michiel E. Ultee
Michiel E. Ultee of Laureate Biopharmaceutical Services gives an update on 1988 article regarding virus testing and how the advance of monoclonal antibodies has changed processes.
Guest Editorial
Joint Regulatory Conferences: The Ultimate Connection
By Richard Johnson
PDA's strategic plan calls for maintaining valuable relationships with global regulators.
Global Reports
Discovery Pipeline: NIH Invests in Tissue Chips
By Amy Ritter, PhD
NIH has awarded ten laboratories two-year grants to develop tissue chip technology, with part of the funding coming from the recently established National Center for Advancing Translational Science.
Report from Brazil
By Hellen Berger
Brazil's regulatory health authority, Anvisa, plans to establish quality requirements for locally produced pharmaceutical excipients, Anvisa told BioPharm International.
Regulatory Beat
Campaign Mounts to Curb Counterfeit Drugs
By Jill Wechsler
Manufacturers and regulators struggle to control phony versions of crucial medicines.
Perspectives on Outsourcing
The Macro View
By Jim Miller
The weak global economy adds to the challenges of bio/pharma companies and their suppliers.
Boot Camp Business Guide
Training the Biopharma Industry
By Killian O'Driscoll
Using a competency-based approach to effectively train biopharmaceutical industry staff.
Boot Camp Technical Guide
Upstream Processing: A Primer
NIBRT's Ian Nelligan on what to expect when starting an upstream process, including the choice between single-use and stainless-steel bioreactors.
Final Word
Technology Transfer: Protecting the True Public Interest
By Jim Greenwood
Ties between the biotechnology industry and university research are crucial.

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