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BioPharm International-08-01-2012
BioPharm International
BioPharm International, August 2012 Issue (PDF)
August 01, 2012
Issue PDF
25
8
Advances in Protein Analysis
Pre-use Filter-Integrity Testing: To Test or not to Test?
August 01, 2012
Disposables Advisor
25
8
There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.
Streamlining Batch Record Review and Approval
August 01, 2012
Manufacturing Best Practices
25
8
A one-day sign off for batch records is considered a best practice in the industry.
Report from Japan
August 01, 2012
Global Reports
25
8
After a series of government reforms, the Japanese pharma market is making a comeback.
Compressing Drug Development Timelines with Accelerated Immunoassay
August 01, 2012
Bioanalytical Best Practices
25
8
Recently developed immunoassay technology platforms reduce sample volume requirements and improve cycle times.
FDA User-Fee Legislation
August 01, 2012
Regulatory Beat
25
8
Import controls and risk strategies aim to promote quality and spur new drug development.
A 25-Year Retrospective on Orphan Drugs
August 01, 2012
Features
25
8
A look back at the history of orphan drugs in the industry.
Discovery Pipeline: Topical Delivery of siRNA
August 01, 2012
Global Reports
25
8
A team from Northwestern University has demonstrated the feasibility of topical delivery of small interfering RNA (siRNA).
Gauging Biopharm Outsourcing
August 01, 2012
Perspectives on Outsourcing
25
8
Budgets for biopharma activities are gaining in select functional areas, except outsourcing.
Performing Hydrogen/Deuterium Exchange with Mass Spectrometry
August 01, 2012
Features
25
8
In HDX studies, data are produced across multiple time points, multiple species, and with replicates.
Tools for Enabling Process Analytical Technology Applications in Biotechnology
August 01, 2012
Features
25
8
The authors review the various analytical methods that can enable use of PAT.
Nuclear Magnetic Resonance as a Bioprocessing QbD Application
August 01, 2012
Features
25
8
Current expectations in bioprocessing and a framework for using NMR to enhance a QbD approach.
Healthcare Reform and Next Steps for BioPharma
August 01, 2012
Guest Editorial
25
8
Now that the Supreme Court has upheld the Affordable Care Act, what's next for biopharma?
Building a Business Case for Biopharmaceutical QbD Implementation (Peer Reviewed)
August 01, 2012
Features
25
8
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 01, 2012
Boot Camp Business Guide
25
8
Members from an ASQ working group provide analytical methods to enable PAT.