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.