Pharmaceutical Technology, May 2, 2014 - Pharmaceutical Technology

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Latest Issue
PharmTech Europe

Pharmaceutical Technology, May 2, 2014
Cover Story
Freeze Drying Protein Formulations
By Adeline Siew, PhD
Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.
Special Report
Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process Considerations
By Brian Gregg , Aleksander Swietlow , Anita Y. Szajek , Harold Rode , Michael Verlander , Ivo Eggen
USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
Formulation
Extractables and Leachables Testing
By Adeline Siew, PhD
Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.
Peer-Reviewed
Achieving Zero-Order Release Kinetics Using Multi-Step Diffusion-Based Drug Delivery
By Abhijit Gokhale
Zero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers.
Regulatory Watch
Demand for New Vaccines Spurs Innovation
By Jill Wechsler
New formulations and expanded vaccine production are encouraged.
Insider Solutions
Linking Drug Shortages and Quality Metrics
By Susan J. Schniepp
Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.
Exclusive coverage from PharmTech Europe
Boosting New Antibiotic Drug Development in Europe
By Faiz Kermani
With the rising threat of antibiotic resistance and a diminishing R&D pipeline for novel drugs, Europe must step up its game to address this growing problem.
EU Steps Up Inspection Efforts
By Sean Milmo
The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.
API Synthesis & Manufacturing
Scientific Advances in Cocrystals are Offset by Regulatory Uncertainty
By Cynthia Challener, PhD
Drug developers are taking a wait-and-see approach to the use of cocrystals.
Outsourcing Outlook
Stuck in Neutral
By Jim Miller
The CMO industry's value proposition is limiting its market penetration.
Global Feature
India's Developing Market Offers Opportunities
By Jill E. Sackman, PhD , Michael Kuchenreuther
Biopharma companies should not overlook India's growing market.
Troubleshooting
Data Management in Manufacturing
By Jennifer Markarian
Pharmaceutical Technology spoke with Gloria Gadea-Lopez, associate director of Shire, and Martin Dittmer, PharmaSuite product manager at Rockwell Automation, about how manufacturing execution systems (MES) can improve productivity and the current challenges faced by companies implementing MES systems.
Special Feature
Data Integrity in the Analytical Laboratory
By Paul Smith
Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.
Ask the Expert
Quality-Technical Agreements
By Siegfried Schmitt
Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements.
Product Spotlight
Mass Spectrometer Enhances Performance in Protein Analysis
By Melanie Sena
Mass Spectrometer Enhances Performance in Protein Analysis
Laser Diffraction Software Supports Analytical QbD
By Melanie Sena
Laser Diffraction Software Supports Analytical QbD
Aggregation System Improves Analysis of Sub-Visible Particles
By Melanie Sena
Aggregation System Improves Analysis of Sub-Visible Particles
Microscope Enables High-Resolution Materials Analysis
By Melanie Sena
Microscope Enables High-Resolution Materials Analysis
Industry Leaders: Q&A
Q&A with Tony Mitchell, Pharma Tech Industries
By Melanie Sena
Tony Mitchell of Pharma Tech Industries discusses the handling and packaging of pharmaceutical powders.
From The Editor
Biopharma Takes a Nervous Glance Over Its Shoulder
By Rita Peters
Changes are needed to maintain US biopharma innovation leadership.

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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
32%
Breakthrough designations
8%
Protecting the supply chain
40%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
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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