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Pharmaceutical Technology-07-02-2009
Pharmaceutical Technology
Pharmaceutical Technology, July 2009 Issue (PDF)
July 02, 2009
Issue PDF
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7
Down the Track: Different Speeds with Multiple APIs
Using NIR to Move Bioprocessing into a PAT Framework
July 02, 2009
Special Section: Bioprocessing 2009
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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.
East Meets West in Contract Biologics Manufacturing
July 02, 2009
Outsourcing Outlook
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A joint biopharmaceutical manufacturing facility in India by Kenwell and Boehringer Ingelheim ushers in new era.
Down the Track: Different Speeds with Multiple APIs
July 02, 2009
Special Report
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Formulators and manufacturers have many options for modifying release profiles in multiple-API products.
Integration of PAT in Biopharmaceutical Research: A Case Study
July 02, 2009
Special Section: Bioprocessing 2009
33
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This case study describes the implementation of process analytical technology on the cultivation process step of a whole-cell vaccine against whooping cough disease.
A Tale of Two Techniques
July 02, 2009
Online Exclusives
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Pan coating has been the preferred method of coating tablets for more than 20 years, but core coating is becoming more popular.
Manufacturers Face New Risk-Management Requirements
July 02, 2009
Washington Report
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REMS to improve the safe use of opioids may lead to controls on other high-risk medicines.
Can Industry Learn to Share?
July 02, 2009
PharmTech Talk
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The regulators are doing it. But industry's fear of sharing information may leave them behind.
Next-Generation Facilities for Monoclonal Antibody Production
July 02, 2009
Special Section: Bioprocessing 2009
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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.
The Biopharmaceutical Manufacturing Survey
July 02, 2009
Special Section: Bioprocessing 2009
33
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A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.
In the Spotlight July 2009
July 02, 2009
In the Spotlight
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Editors' Picks of Pharmaceutical Science & Technology Innovations
Modification and Characterization of Gellan Gum
July 02, 2009
Peer-Reviewed Research
33
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The authors modified gellan gum using microwave technology and showed it can be used as an excipient in tablet formulations.
Novel Approaches for Oral Insulin Delivery
July 02, 2009
Online Exclusives
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The authors review various oral drug delivery systems that have been explored to increase patient compliance for insulin.
Opportunities and Challenges in Pharmaceutical Nanotechnology
July 02, 2009
Viewpoint
33
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While regulators begin to address nano-based drugs, industry should get its risk data ready.
Wasting Away
July 02, 2009
Agent-In-Place
33
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Some GMP agents seem to find a way to squander time, money, and common sense.
Examining High-Potency API Manufacturing
July 02, 2009
Ingredients Insider
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High-potency manufacturing of active pharmaceutical ingredients is a growing and specialized capability.
Inside USP: Traditional Chinese Medicines and Western Regulatory Paradigms
July 02, 2009
Inside USP
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Traditional Chinese Medicine is widely used, but questions persist regarding its regulatory status.
Debunking the Bottleneck Myth
July 02, 2009
Special Section: Bioprocessing 2009
33
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A look at the true cost-drivers of cell-culture production.
Less Is More for Low-Dose Drugs
July 02, 2009
Online Exclusives
33
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Developers of low-dose drugs in solid oral dosage forms will find theoretical considerations and practical advice in a new book.
Cleaning Verification: Method Development and Validation Using Ion Mobility Spectrometry
July 02, 2009
Peer-Reviewed Research
33
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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.
Stabilization of Interferon alpha-2b in a Topical Cream
July 02, 2009
Special Section: Bioprocessing 2009
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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.
Large-Scale Manufacture of Therapeutic Human Stem Cells
July 02, 2009
Special Section: Bioprocessing 2009
33
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Large-scale manufacturing of human stem cells for therapeutic use is a leap in technology and science for the current biotechnology industry.
Outsourced Vaccine Development
July 02, 2009
Special Section: Bioprocessing 2009
33
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The authors discuss how strategic outsourcing to contract manufacturing organizations that have technical and regulatory expertise can add further value during vaccine development.
Report From India: A new patent battleground has formed over India's drug shipments through the European Union.
June 11, 2009
News
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Patent infringement claims and a lack of clear global trade distribution routes may be unraveling the country's generic-drug export industry.