Pharmaceutical Technology, Nov 2, 2013 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Nov 2, 2013
Cover Story
Can Pharma Defy Gravity at the Patent Cliff?
By Adeline Siew
Pharmaceutical companies are using formulation strategies as a lifecycle management tool to maximize product value and preserve their revenue streams.
Ask the Expert
Compliance in Quality Systems
Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.
Peer Reviewed
Predicting Long-Term Storage Stability of Therapeutic Proteins
By Simon Webster
Predicting long-term storage stability of a given protein and formulation is desirable for effective screening and optimization early in the development process. Multiple routes to aggregation during storage to suggest that multiple measurement types should be made to probe different aspects of protein behavior.
API Synthesis & Manufacturing
Applying Catalysis to Optimize API Synthesis
By Patricia Van Arnum
Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.
Solutions in Pharmaceutics
Solvent-Free Coating of Traditional and User-Friendly Dosage Forms
By Detlev Haack, , Martin Koeberle
The benefits of solvent-free processes and techniques specifically optimized for coating new dosage forms such as orally disintegrating granules are reviewed.
Defining and Presenting Overkill Cycle Validation
By John Anderson
Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.
Regulatory Watch
Congress Revises Rules for Drug Compounding and Supply-Chain Security
By Jill Wechsler
Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.
European Union Introduces GMPs for Excipients
By Sean Milmo
Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.
Outsourcing Outlook
Disposable Applications in Demand by Biopharma
By Eric Langer
Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.
Inside EDQM
Control of Elemental Impurities
By Susanne Keitel
The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.
Global Feature
Report from Brazil
By Hellen Berger
New regulation offers patients in Brazil greater access to experimental drugs.
Product Spotlight
Database Improves Process Efficiency
Database Improves Process Efficiency
Automation System Improves Operational Insight
Automation System Improves Operational Insight
Wireless Network Monitors Air Cooled Heat Exchanger
Wireless Network Monitors Air Cooled Heat Exchanger
System Links Packaging Operations
System Links Packaging Operations
From The Editor
New Funding and Approval Pathways Prove Popular
By Rita Peters
The JOBS Act and FDASIA show early signs of accelerating drug development.


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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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