BioPharm International, August 2012

Features

Nuclear Magnetic Resonance as a Bioprocessing QbD Application

By F.C. Girard

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

Tools for Enabling Process Analytical Technology Applications in Biotechnology

By Rakesh Mendhe , Anurag S. Rathore , Ira S. Krull

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

Performing Hydrogen/Deuterium Exchange with Mass Spectrometry

By St. John Skilton

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

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

By Beth H. Junker

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

A 25-Year Retrospective on Orphan Drugs

By Michael N. Abrams

A look back at the history of orphan drugs in the industry.

Guest Editorial

Healthcare Reform and Next Steps for BioPharma

By Jill Wechsler

Now that the Supreme Court has upheld the Affordable Care Act, what's next for biopharma?

Global Reports

Discovery Pipeline: Topical Delivery of siRNA

By Amy Ritter, PhD

A team from Northwestern University has demonstrated the feasibility of topical delivery of small interfering RNA (siRNA).

Report from Japan

By Jane Wan

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

Regulatory Beat

FDA User-Fee Legislation

By Jill Wechsler

Import controls and risk strategies aim to promote quality and spur new drug development.

Disposables Advisor

Pre-use Filter-Integrity Testing: To Test or not to Test?

By Jerold Martin

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

Perspectives on Outsourcing

Gauging Biopharm Outsourcing

By Eric S. Langer

Budgets for biopharma activities are gaining in select functional areas, except outsourcing.

Manufacturing Best Practices

Streamlining Batch Record Review and Approval

By Simon Chalk

A one-day sign off for batch records is considered a best practice in the industry.

Bioanalytical Best Practices

Compressing Drug Development Timelines with Accelerated Immunoassay

By Mark J. Cameron

Recently developed immunoassay technology platforms reduce sample volume requirements and improve cycle times.

Boot Camp Business Guide

Best Quality Practices for Biomedical R&D

By A. Mark Trotter

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