Pharmaceutical Technology, Jul 2, 2009 - Pharmaceutical Technology

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Pharmaceutical Technology, Jul 2, 2009
Online Exclusives
Less Is More for Low-Dose Drugs
By Heinz Sucker, PhD
Developers of low-dose drugs in solid oral dosage forms will find theoretical considerations and practical advice in a new book.
Novel Approaches for Oral Insulin Delivery
By S. Dhawan , S. Chopra , R. Kapil , D. Kapoor
The authors review various oral drug delivery systems that have been explored to increase patient compliance for insulin.
A Tale of Two Techniques
By Erik Greb
Pan coating has been the preferred method of coating tablets for more than 20 years, but core coating is becoming more popular.
Special Report
Down the Track: Different Speeds with Multiple APIs
By Maribel Rios , Erik Greb
Formulators and manufacturers have many options for modifying release profiles in multiple-API products.
Peer-Reviewed Research
Modification and Characterization of Gellan Gum
By Dhiren P. Shah , Girish K. Jani
The authors modified gellan gum using microwave technology and showed it can be used as an excipient in tablet formulations.
Cleaning Verification: Method Development and Validation
By Elizabeth Galella , Scott Jennings , Madhavi Srikoti , Elizabeth Bonasso
The authors discuss the theory of ion mobility spectrometry, its benefit over HPLC analysis in cleaning verification, and the experimental considerations for method validation and validation.
Special Section: Bioprocessing 2009
The Biopharmaceutical Manufacturing Survey
By Michelle Hoffman
A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.
Next-Generation Facilities for Monoclonal Antibody Production
By Niels Guldager
Dramatic increases in yields from cell lines and the increasing popularity of single-use technologies will change the way we look at future bioprocessing facilities and process designs.
Large-Scale Manufacture of Therapeutic Human Stem Cells
By Robert J. Thomas , David J. Williams
Large-scale manufacturing of human stem cells for therapeutic use is a leap in technology and science for the current biotechnology industry.
Stabilization of Interferon alpha-2b in a Topical Cream
By Praveen Kumar , Ravinderjit Batta , Geriene LaBine , Jinghui Shen , Kim Gaspar , John Docherty , Marianna Foldvari
The authors describe a proprietary process for producing a stable, topical interferon alpha-2b formulation that can deliver large drug molecules into the skin or mucosa.
Debunking the Bottleneck Myth
By Günter Jagschies
A look at the true cost-drivers of cell-culture production.
Using NIR to Move Bioprocessing into a PAT Framework
By Todd Strother
The author provides a review of PAT and tools such as near infrared analysis that may facilitate the use of PAT in the biopharmaceutical sector.
Integration of PAT in Biopharmaceutical Research: A Case Study
By Kjell François , Mathieu Streefland , Rebecca Vangenechten , Leo Hammendorp
This case study describes the implementation of process analytical technology on the cultivation process step of a whole-cell vaccine against whooping cough disease.
Outsourced Vaccine Development
By Phil Ball , Maria Lusk
The authors discuss how strategic outsourcing to contract manufacturing organizations that have technical and regulatory expertise can add further value during vaccine development.
Ingredients Insider
Examining High-Potency API Manufacturing
By Patricia Van Arnum
High-potency manufacturing of active pharmaceutical ingredients is a growing and specialized capability.
Outsourcing Outlook
East Meets West in Contract Biologics Manufacturing
By Patricia Van Arnum
A joint biopharmaceutical manufacturing facility in India by Kenwell and Boehringer Ingelheim ushers in new era.
Washington Report
Manufacturers Face New Risk-Management Requirements
By Jill Wechsler
REMS to improve the safe use of opioids may lead to controls on other high-risk medicines.
Agent-In-Place
Wasting Away
By Control, a senior compliance officer
Some GMP agents seem to find a way to squander time, money, and common sense.
From The Editor
The Good Society
By Michelle Hoffman
Is it good policy to pay for bad behavior?
Viewpoint
Opportunities and Challenges in Pharmaceutical Nanotechnology
By David W. Hobson
While regulators begin to address nano-based drugs, industry should get its risk data ready.
PharmTech Talk
Can Industry Learn to Share?
By Angie Drakulich
The regulators are doing it. But industry's fear of sharing information may leave them behind.
Inside USP
Inside USP: Traditional Chinese Medicines and Western Regulatory Paradigms
By James C. Griffiths
Traditional Chinese Medicine is widely used, but questions persist regarding its regulatory status.
News
Report From: India
By A. Nair
Patent infringement claims and a lack of clear global trade distribution routes may be unraveling the country's generic-drug export industry.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for July 2009.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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