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Regulatory Challenges in the QbD Paradigm

September 1, 2012

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

Report from Brazil

September 1, 2012

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

A Method for Removal of Endotoxin from Pharmaceutical Formulation

September 1, 2012

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

Performing Hydrogen/Deuterium Exchange with Mass Spectrometry

August 1, 2012

In HDX studies, data are produced across multiple time points, multiple species, and with replicates.

Report from Japan

August 1, 2012

After a series of government reforms, the Japanese pharma market is making a comeback.

Nuclear Magnetic Resonance as a Bioprocessing QbD Application

August 1, 2012

Current expectations in bioprocessing and a framework for using NMR to enhance a QbD approach.

Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)

August 1, 2012

The author describes a methodology for developing a per product qualitative and semi-qualitative business case for applying QbD to a biopharmaceutical product.

Best Quality Practices for Biomedical R&D

August 1, 2012

Members from an ASQ working group provide analytical methods to enable PAT.

Tools for Enabling Process Analytical Technology Applications in Biotechnology

August 1, 2012

The authors review the various analytical methods that can enable use of PAT.

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