Pharmaceutical Technology, Oct 2, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, Oct 2, 2011
Online Exclusives
Biopharmaceuticals from Plan to Production
By Jim Fernandez
Management of the product plan and details for biopharmaceutical production are included in an integrated review of biotechnology operations.
Pfizer Outlines Its Supply Strategy
By Patricia Van Arnum
John Kelly, vice-president of strategy and transitioning sites for Pfizer Global Supply, discusses the company's manufacturing and supply strategy and network.
Special Reports
Reformulating Injectables for Oral Delivery
By Erik Greb
Could oral absorption-enhancing technologies change the shape of protein delivery?
Single-use Technologies in Fill–Finish Operations
By Amy Ritter
Single-use components in the fill–finish line provides increased flexibility to multiproduct manufacturers.
Special Features
FDA/Industry Perspectives: Detection, Measurement, and Control in Manufacturing
By Margeret M. Szymczak , Richard L. Friedman , Rajendra Uppoor , Avraham Yacobi
The authors summarize a recent FDA–PQRI workshop on process drift.
PQRI Case Study (4): Process Deviation and Empty Product Capsules
By Ted Frank , Stephen Brooks , Kristin Murray , Steve Reich , Ed Sanchez , Brian Hasselbalch , Kwame Obeng , Richard Creekmore
This risk-management case study focuses on assessing empty capsules.
The Matrixx Zicam Verdict
By Cathy Burgess , Sean Simmons , Lynn D. Torbeck
The authors summarize the Matrixx Initiatives, Inc. v. Siracusano case's implications for industry.
Quality Issues for Multiregional Clinical-Trial Materials
By Dennis Sandell , Terrence Tougas , Dennis O'Connor , Steve Horhota
The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.
Peer-Reviewed Research
Assessment of Large-Sample Unit-Dose Uniformity Tests
By Yanhui Hu , David LeBlond
The authors describe the concept of the limiting discriminatory the limiting discriminatory threshold (LDT) as an objective means of evaluating the inherent quality requirement of a large-sample content-uniformity test.
Applying Dry Powder Coatings
By Matthew P. Mullarney , Lauren E. Beach , Beth A. Langdon , Mark A. Polizzi
The authors experiment with a resonant acoustic mixer as a method for dry powder coating.
Guest Editorial
Advancing with the Times
By Philip R. Mayer
Despite new hurdles, industry must move forward and fulfill its mission.
PharmTech Talk
Is Noncompliance Just Human Nature?
By Angie Drakulich
Corporate management must be held accountable for quality at all levels.
Inside EDQM
Inside EDQM: Mass Serialization to Combat Counterfeit Drugs
By Susanne Keitel
Europe establishes new collaborative system to track products.
Inside PIC/S
Inside PIC/S: The Importance of PIC/S in a Globalized World
By Tor Graberg
Expanding the organization's mandate will strengthen inspections.
In the Field
Report from India
By A. Nair
In an effort to balance bilateral trade, India is urging China to increase Indian pharmaceutical imports.
Global Healthcare on the Ground: AAPS on Why Global HealthCare is Important Now
By Angie Drakulich
AAPS Global Health Focus Group's Kishor M. Wasan discusses new initiatives.
Agent-In-Place
Time is of the Essence
By Control, a senior compliance officer
Letting contamination build up can cause multiple headaches.
In the Spotlight
In the Spotlight
New product reviews for October 2011 focusing on analytical instrumentation.
Washington Report
Global Health Challenges Spur Vaccine Development
By Jill Wechsler
Manufacturers fund research and reduce prices to tackle diseases.
BioForum
Biotech Venture Funding Slips Below 2010 Levels
By Tracey T. Lefteroff
Average deal size and amounts invested increased in the second quarter, but totals trail funding of last year.
Statistical Solutions
OOS, OOT, OOC, and OOSC
By Lynn D. Torbeck
Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.
Packaging Forum
Sustainability Outside the Box
By Hallie Forcinio
Drugmakers and packagers are pursuing various initiatives to reduce their carbon footprints. This article contains bonus material.
Pharma Ingredients
Sizing Up the Global Market for Excipients
By Patricia Van Arnum
The global excipients market shows moderate growth, increased consolidation, and expansion activity in emerging markets and select product areas.
Outsourcing Outlook
Preparing for the Last War
By Jim Miller
CROs that have made big acquisitions could be outmaneuvered by evolving sourcing models.
Industry Leaders
Q&A with Rao Tatapudy, Catalent
A Q&A with Rao Tatapudy, vice-president of scientific affairs at Catalent, on recent industry trends.
Viewpoint
Managing Business Risks During a Merger or Acquisition
By James W. Bedford , Mark Ehlert
Getting the most value out of M&As requires proper upfront legwork.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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