BioPharm International-09-01-2012

BioPharm International

A 25-Year Retrospective on Bioprocessing mAbs

September 01, 2012

Features

25

9

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.

Technology Transfer: Protecting the True Public Interest

September 01, 2012

Final Word

25

9

Ties between the biotechnology industry and university research are crucial.

Training the Biopharma Industry

September 01, 2012

Boot Camp Business Guide

25

9

Using a competency-based approach to effectively train biopharmaceutical industry staff.

The Macro View

September 01, 2012

Perspectives on Outsourcing

25

9

The weak global economy adds to the challenges of bio/pharma companies and their suppliers.

In-Depth Validation of Closed-Vial Technology

September 01, 2012

Features

25

9

The authors describe a validation master plan for closed-vial filling technology.

Regulatory Challenges in the QbD Paradigm

September 01, 2012

Features

25

9

The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.

A Method for Removal of Endotoxin from Pharmaceutical Formulation

September 01, 2012

Features

25

9

The authors describe a simple method to remove endotoxins from highly viscous formulations.

Bucking the Trend

September 01, 2012

Features

25

9

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.

Discovery Pipeline: NIH Invests in Tissue Chips

September 01, 2012

Global Reports

25

9

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.

Joint Regulatory Conferences: The Ultimate Connection

September 01, 2012

Guest Editorial

25

9

PDA's strategic plan calls for maintaining valuable relationships with global regulators.

Upstream Processing: A Primer

September 01, 2012

Boot Camp Technical Guide

25

9

NIBRT's Ian Nelligan on what to expect when starting an upstream process, including the choice between single-use and stainless-steel bioreactors.

Report from Brazil

September 01, 2012

Global Reports

25

9

Brazil's regulatory health authority, Anvisa, plans to establish quality requirements for locally produced pharmaceutical excipients, Anvisa told BioPharm International.

Challenges and Opportunities for Biosimilars Developers

September 01, 2012

Features

25

9

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.

Campaign Mounts to Curb Counterfeit Drugs

September 01, 2012

Regulatory Beat

25

9

Manufacturers and regulators struggle to control phony versions of crucial medicines.