BioPharm International, May 2013 - BioPharm International

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BioPharm International, May 2013
Features
Measuring Protein Mobility with Electrophoretic Light Scattering
By Stephen Ball
The author describes a method to avoid protein aggregation when using light scattering systems.
Process Development and Spiking Studies for Virus Filtration of r-hFSH
By Mahesh Gavasane , Ansari Usman Ali , Anita Samagod , John Kaundinya , Gautam Daftary , Thomas Preuss , Horst Ruppach , Nikhil Shaligram , Bala Raghunath , Subhasis Banerjee
This study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
The Future of Valves and Diaphragms Supply
By Steve Jones
The author discusses issues related to the supply of soft parts in the biopharma industry.
Extractables and Leachables: Best Practices to Ensure Patient Safety
By Thomas Feinberg, PhD
The author presents best practices for extractables and leachables.
New Challenges to the Cleanroom Paradigm for Multi-Product Facilities
By Simon Chalk , Scott Probst , Ken Green , Russell Moser , Frank Urbanski , Matthew Zicaro , Paul Smock , Larry Pranzo , Liz Dooley , Phil McDuff
Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.
Facility Trends: Modularization and Single Use
By Jennifer Markarian
BioPharm International spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.
From the Editor
The Pathway to Publication
By Rita Peters
Wanted: Aspiring authors to share technical and scientific solutions for biopharmaceutical processing.
Global News
Report from Brazil
By Hellen Berger
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.
Regulatory Beat
Regulatory Convergence Sought for Global Pharma Market
By Jill Wechsler
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
European Beat
Should Regulation of Combination Products Become More Centralized in Europe?
By Sean Milmo
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.
Perspectives on Outsourcing
Outsourcing's Modest Role as a Cost-Containment Strategy
By Eric S. Langer
Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon.
Boot Camp Business Guide
Data and Systems Management
KR Karu from Sparta Systems spoke with BioPharm International about the importance of having an enterprise quality management system.
Analytical Best Practices
Essentials in Quality Risk Management
By Thomas A. Little, PhD
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.

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