BioPharm International, August 2012 - BioPharm International

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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.

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