BioPharm International May 2013

May 2013 | Volume 26, Issue 5
Features
BioPharm International spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.
The author describes a method to avoid protein aggregation when using light scattering systems.
Additional challenges to the new cleanroom paradigm from concurrent multiproduct manufacturing of bulk drug substances in a controlled non-classified (CNC) ballroom environment.
The author discusses issues related to the supply of soft parts in the biopharma industry.
This study on a recombinant human follicle stimulating hormone demonstrates the use of virus filters to reduce the risk of contamination.
The author presents best practices for extractables and leachables.
From the Editor
Wanted: Aspiring authors to share technical and scientific solutions for biopharmaceutical processing.
Global News
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
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
European Beat
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 is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon.
Boot Camp Business Guide
By BioPharm International Editors
KR Karu from Sparta Systems spoke with BioPharm International about the importance of having an enterprise quality management system.
Analytical Best Practices
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.