BioPharm International, April 2012 - BioPharm International

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BioPharm International, April 2012
Features
Optimizing Adjuvant Filtration
A technical rountable featuring Sartorius Stedim Biotech, Pall Life Sciences, 3M Purification, Asahi Kasei Bioprocess, and Bio-Rad Laboratories.
Single-Use Redundant Filtration
By Ranjeet Patil , Michael Felo , George Oulundsen
The authors describe a new assembly for bulk and final drug product filling operations.
Pointed Debate
Industry experts discuss the benefits and challenges of self-administration of injectable therapies.
Knowledge Management Implementation
By Tarun Jain , Bipul Pandey
The authors discuss the technology and guidance required to achieve good KM in a biopharmaceutical company.
A 25-Year Retrospective on GMP Training
This month, we rewind to an article titled "Good Manufacturing Practices Training."
Guest Editorial
PDA Tackles Changing Industry Times
By Richard Johnson
The confluence of science, technology, and regulation will provide our industry with the guidance to move forward.
A Look at INTERPHEX 2012
By Bob Stewart
Collaboration can begin with a conversation.
Regulatory Beat
Manufacturers Wrestle with Drug Abuse and Critical Shortages
By Jill Wechsler
Soaring opioid use creates challenges for new drug development and supply-chain control.
Perspectives on Outsourcing
Ways to Recover Lost Margins
By Gregg Brandyberry
Recovery audits and other best practices in procurement can improve the bottom line.
Compliance Notes
Preparing for an FDA Inspection in a Global Pharmaceutical Environment
By James R. Johnson
FDA has created a dedicated cadre of foreign drug investigators and established permanent offices worldwide.
Burrill on Biotech
A Strong Start to 2012
By G. Steven Burrill
Better news about the global economy buoys life-sciences funding.
Boot Camp Business Guide
Growing Your Biopharmaceutical Product Pipeline
By Tarja Mottram
BioPharm talks with Tarja Mottram, CEO of Action for Results, about key business considerations when starting out.
Manufacturing Best Practices
Small Changes, System-Wide Impact
By Simon Chalk
A closer look at elastomer changeout times provides one example of using industry knowledge to improve operations and cost.
Final Word
The Growing Orphan-Drug Paradigm
By Rita E. Numerof , Michael N. Abrams
Rather than seeking a single indication for one large group, the orphan-drug approach segments the market for a drug more minutely.

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