BioPharm International, December 2013 - BioPharm International

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BioPharm International, December 2013
Cover Story
Employment Outlook: Mixed Results
By Rita Peters
The employment picture brightened a bit, but biopharma employees still seek better compensation.
Features
Biotechnology Innovation and Growth in Israel
By Jill E. Sackman , Michael Kuchenreuther
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.
Comparing Protein A Resins for Monoclonal Antibody Purification
By Shohei Kobayashi , Yasufumi Ueda
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
Implementing QbD in Sterile Manufacturing
By Susan Haigney
Wolfgang Weikmann of Vetter Pharma discusses the implementation of quality by design in sterile manufacturing.
Analytical Best Practices
Understanding and Modeling Product and Process Variation
Variation understanding and modeling is a core component of modern drug development.
Peer-Reviewed Research
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
By Mark Mitchell
Criticality is used as a risk-based tool to drive control strategies.
Regulatory Beat
Opioid Regulation Challenges FDA and Manufacturers
By Jill Wechsler
New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
European Beat
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
By Sean Milmo
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
Clinical Trials Head East to Asia
By Jane Wan
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
Climate Change in Outsourcing
By Jim Miller
Ongoing changes create new opportunities for CROs and CMOs.
From the Editor
Jobs Are Better in Biopharma, But There Is Room for Improvement
By Rita Peters
Higher wages and employment rates give biopharm professionals an edge over counterparts in other industries.

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