Pharmaceutical Technology, Mar 2, 2007 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Mar 2, 2007
Articles
Process Patent Protection: Characterizing Synthetic Pathways by Stable-Isotopic Measurements
By John P. Jasper , Larry E. Weaner , John M. Hayes
The authors describe the methods by which precise analyses of stable-isotopic abundances can be used in security and forensic applications for pharmaceutical materials. These methods include product and process authentication of raw materials, pharmaceutical intermediates, drug substances, formulated drug products, and synthetic pathways. Collectively, these methods can be used to investigate and mitigate patent infringement. In the future, more complete examples will be presented containing full isotopic results and the application of the methods described in this article.
The Advantages of Restricted-Access Barrier Systems
By Johannes Rauschnabel
Filling machines often are installed in sterile rooms and separated by isolators to prevent contamination. These methods have certain drawbacks, including making interventions more difficult. Restricted-access barrier systems are an alternative that ensures sterility and facilitates interventions.
Shifting Patterns in Sourcing
By Patricia Van Arnum
The pharmaceutical supply chain lengthens as generic drug manufacturers build production platforms offshore and CMOs position in India and China to meet demand for lower-cost production.
Big Shot: Developments in Prefilled Syringes
By Brianne Harrison , Maribel Rios
Many companies are coming up with innovative materials and manufacturing methods to feed the growing demand for prefilled syringes.
Book Review
Getting under Our Skin: The Evolving Field of Transdermal Delivery
By Harvinder Singh Gill
The book is written for drug-delivery scientists experienced in the dermatological or transdermal fields.
Outsourcing
Pfizer Restructuring a Boon to CMOs and CROs
By Jim Miller
As big pharmaceutical companies restructure and reevaluate the way they do business, contract research and manufacturing organizations could reap greater financial rewards.
Agent-In-Place
Maintain Your Moving Parts
By Control, a senior compliance officer
Just because the wheels are turning doesn't mean they're going forward.
Washington Report
Accelerating Drug Development
By Jill Wechsler
FDA's new safety program, Critical Path Initiative, and user-fee proposal seek to reinvigorate pharmaceutical R&D.
Packaging Forum
Packaging Trends
By Hallie Forcinio
Security, the environment, aging populations, the bio-boom, and cost control are just a few of the drivers that will influence pharmaceutical packaging for the remainder of this decade.
Viewpoint
The Pharmaceutical Industry Looks to Reduce Waste by Getting Lean
By Scott Geller
The low-volume pharmaceutical industry must adapt Lean Manufacturing tools invented for high-volume, single product industries.
From The Editor
What Will It Mean to the Patient?
By Douglas McCormick
Before we can intelligently set the limits of process variation, we need to know what the clinical impact of that variation will be.
This Time Around
Pursuits of Business
By Maribel Rios
The Parenteral Drug Association recently held its first global conference on emerging manufacturing technologies. Among the presentations were those discussing the latest in disposable technologies, aseptic filling and closing, and barrier systems. Clearly, technology vendors have stepped up efforts to streamline processes and better handle complex drug products.
In the Field
March 2007
The proposed rule would impose new record-keeping requirements on some 1200 manufacturing establishments.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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Reducing drug shortages
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Expedited reviews of drug submissions
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More stakeholder involvement
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View Results
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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