BioPharm International-08-01-2012

Advances in Protein Analysis

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

Manufacturing Best Practices

August 01, 2012

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

Global Reports

August 01, 2012

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

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

Regulatory Beat

August 01, 2012

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

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

Global Reports

August 01, 2012

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

Perspectives on Outsourcing

August 01, 2012

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

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

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

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

Guest Editorial

August 01, 2012

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

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

Boot Camp Business Guide

August 01, 2012

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