BioPharm International December 2013

December 2013 | Volume 26, Issue 12
Cover Story
The employment picture brightened a bit, but biopharma employees still seek better compensation.
Features
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R'D, clinical research, and market growth.
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.
Analytical Best Practices
By BioPharm International Editors
Variation understanding and modeling is a core component of modern drug development.
Peer-Reviewed Research
Criticality is used as a risk-based tool to drive control strategies.
Regulatory Beat
New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
European Beat
The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).
Global News
The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.
Perspectives in Outsourcing
Ongoing changes create new opportunities for CROs and CMOs.
From the Editor
Higher wages and employment rates give biopharm professionals an edge over counterparts in other industries.