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BioPharm International-05-01-2013
BioPharm International
Regulatory Convergence Sought for Global Pharma Market
May 01, 2013
Regulatory Beat
26
5
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
Measuring Protein Mobility with Electrophoretic Light Scattering
May 01, 2013
Features
26
5
The author describes a method to avoid protein aggregation when using light scattering systems.
Should Regulation of Combination Products Become More Centralized in Europe?
May 01, 2013
European Beat
26
5
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
Data and Systems Management
May 01, 2013
Boot Camp Business Guide
26
5
KR Karu from Sparta Systems spoke with BioPharm International about the importance of having an enterprise quality management system.
Report from Brazil
May 01, 2013
Global News
26
5
Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years.
The Future of Valves and Diaphragms Supply
May 01, 2013
Features
26
5
The author discusses issues related to the supply of soft parts in the biopharma industry.
Extractables and Leachables: Best Practices to Ensure Patient Safety
May 01, 2013
Features
26
5
The author presents best practices for extractables and leachables.
Facility Trends: Modularization and Single Use
May 01, 2013
Features
26
5
BioPharm International spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.
New Challenges to the Cleanroom Paradigm for Multi-Product Facilities
May 01, 2013
Features
26
5
Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.
Process Development and Spiking Studies for Virus Filtration of r-hFSH
May 01, 2013
Features
26
5
This study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
The Pathway to Publication
May 01, 2013
From the Editor
26
5
Wanted: Aspiring authors to share technical and scientific solutions for biopharmaceutical processing.
Outsourcing's Modest Role as a Cost-Containment Strategy
May 01, 2013
Perspectives on Outsourcing
26
5
Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon.
Essentials in Quality Risk Management
May 01, 2013
Analytical Best Practices
26
5
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
BioPharm International, May 2013 Issue (PDF)
May 01, 2013
Issue PDF
26
5
Click the title above to open the BioPharm International May 2013 issue in an interactive PDF format.
BioPharm International, May 2012 Issue (PDF)
May 01, 2012
Issue PDF
26
5
Monoclonal Antibodies : Developing an Alternative Polishing Step