Pharmaceutical Technology, May 2, 2013 - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Pharmaceutical Technology, May 2, 2013
Cover Story
Lyophilization: A Primer
By Katriona Scoffin , Laura Ciccolini
Optimized freeze-drying cycles can offer scientific and business advantages.
Controlling Ice Nucleation During the Freezing Step of Lyophilization
By Adeline Siew, PhD
Lyophilization technologies for controlled nucleation.
Special Features
Prefilled Syringes or Peptide Pills?
By Aikaterini Lalatsa, PhD
The impact of new delivery technologies in designing peptide therapies.
API Synthesis & Manufacturing
Intellectual Property Battles in Solid-State Chemistry
By Patricia Van Arnum
The rejection by India's Supreme Court on Novartis' Glivec/Gleevec (imatinib mesylate) and other recent case law raise important issues on patent strategies for solid forms.
Academic and Public Partnerships in Solid-State Chemistry
By Patricia Van Arnum
Solid-state chemistry is an important part of drug development, and public research is advancing the field.
Using Thermal Ink-Jet Printing Technology to Produce Pharmaceutical Cocrystals
By Patricia Van Arnum
Cocrystals are used to improve the performance of APIs that have non-ideal physiochemical properties by cocrystallizing the API with a second compound that modulates the API to provide a way to improve a drug's bioavailability, stability, and processability.
Special Report
Facility Trends: Modularization and Single Use
By Jennifer Markarian
Pharmaceutical Technology spoke with INTERPHEX 2013 conference-session presenters to gain insight on trends in facility and process design.
Regulation & Compliance
Regulatory Roundup
By Jill Wechsler
FDA faces budget crunch; Supreme Court hears key cases
Regulatory Convergence Sought for Global Pharma Market
By Jill Wechsler
Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.
Should Regulation of Combination Products Become More Centralized in Europe?
By Sean Milmo
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
Troubleshooting
Using a Gravimetric Feeder to Dose Pharmaceutical Bulk Solids
Loss-in-weight feeders provide high accuracy for batch or continuous processes.
Peer-Reviewed Research
Enhancing Particle-Size Measurement Using Dry Laser-Diffraction Particle-Size Analysis
By Carl Levoguer
The author examines dry dispersion and outlines the related analytical method development.
Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances
By Bob Mehta
The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.
Statistical Solutions
Compositing Samples and the Risk to Product Quality
By Lynn D. Torbeck
Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.
Outsourcing Outlook
Outsourcing's Modest Role as a Cost-Containment Strategy
By Eric Langer
Outsourcing is weighing in more as a tactic for cost-cutting, but it is still not the primary weapon.
BioForum
ZFN Technology Advances Biopharmaceutical Manufacturing
By Kate Achtien
Applications of ZFN technology in biopharmaceutical cell-line engineering.
Ask the Expert
FDA Expectations for Supplier Management
James Stumpff, Principal Consultant at PAREXEL discusses supplier management and FDA's expectations.
Industry Leaders
Q&A with Stuart E. Needleman, Aptuit
A Q&A with Stuart E. Needleman, President and Chief Operating Officer of Aptuit, on recent industry trends.
Global Feature
Report from Brazil
By Hellen Berger
Prior to price escalation of pharmaceutical products in Brazil, the country's regulatory authority released a study on price-cap control and its benefits in the past years.
Industry Perspectives
Co-Opetition in Drug Development
By Ed Currie
The author suggests co-opetition as a future model for collaboration in drug development.
New First-to-File Patent Rule Threatens Open Collaboration
By Steve Berry
New US patent rules change the playing field for open innovation.
From The Editor
Pathway to Publication
By Rita Peters
Wanted: Article contributions on drug and process development topics.
In the Spotlight
Product Spotlight: Automation/IT/Process Control
New product reviews for May 2013, featuring automation, IT, and process control systems.

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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
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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