BioPharm International
May 01, 2013
Regulatory Beat
26
5
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
May 01, 2013
Features
26
5
The author describes a method to avoid protein aggregation when using light scattering systems.
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.
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.
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.
May 01, 2013
Features
26
5
The author discusses issues related to the supply of soft parts in the biopharma industry.
May 01, 2013
Features
26
5
The author presents best practices for extractables and leachables.
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.
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.
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.
May 01, 2013
From the Editor
26
5
Wanted: Aspiring authors to share technical and scientific solutions for biopharmaceutical processing.
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.
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.
May 01, 2013
Issue PDF
26
5
Click the title above to open the BioPharm International May 2013 issue in an interactive PDF format.
May 01, 2012
Issue PDF
26
5
Monoclonal Antibodies : Developing an Alternative Polishing Step