BioPharm International, June 2012 - BioPharm International

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BioPharm International, June 2012
Online Exclusive
BioPharm Celebrates 25 Years
In this online extra, Board Members comment on major industry changes over the past few decades.
Features
Determining Process Quality Metrics for CMOs
By Kate DeRoche Lusczakoski
Implementing quality by design makes the determination of quality metrics across CMOs and sponsors essential.
25 Years of BioPharma Industry Growth
By Eric S. Langer
A review of key industry shifts and promises for the future.
25 Years of Nanoparticles: A Look Forward
By Amy Ritter, PhD
Panayiotis P. Constantinides of Biopharmaceutical & Drug Delivery Consulting on growth of nanoparticle delivery systems.
25 Years of Protein Expression
By Amy Ritter, PhD
Charles H. Squires of Pfenex discusses advances in expression platform solutions.
New Biopharmaceuticals
By Gary Walsh, PhD
A review of new biologic drug approvals over the years, featuring highlights from 2010 and 2011.
Interview with FDA: Adopting New Strategies to Oversee Global Economy
By Jill Wechsler
In a special anniversary interview, Washington Editor Jill Wechsler speaks with with FDA Deputy Commissioner Deborah Autor about where the agency is headed.
25 Years of Biopharmaceutical Innovation: An Expert Roundtable
Industry experts discuss significant achievements. Plus: What's in store for the future.
Guest Editorial
Back-to-Basics with PDUFA V
By Sara Radcliffe
BIO is calling for a more patient-centric approach to user-fee reauthorization.
Compliance Notes
Know the Regulations
By Susan J. Schniepp
The contract provider needs to know as much as the NDA holder.
Boot Camp Business Guide
Creating a Product Portfolio from the Ground Up
Mike Clayman, CEO of Flexion Therapeutics, talks about his company's strategy to focus on a single therapeutic area.
Manufacturing Best Practices
Reducing Human Error
By Simon Chalk
Leading industry collaborators outline top 10 best practices for human error reduction.
Developing Alternatives to ELISA-Based Biomarker Assays
By Mark J. Cameron , Roger N. Hayes
The authors discuss a new, rapid immunoassay for the detection of biomarkers.
Final Word
Developing Discoveries into New Therapeutics
By Michiel E. Ultee, PhD
Formulators and developers are at the heart of the industry's basic premise—they are saving lives.

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