Pharmaceutical Technology, Apr 2, 2014 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Apr 2, 2014
Cover Story
Increased Efficiency Key to Competitiveness in Downstream Bioprocessing
By Cynthia Challener, PhD
Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.
Featured Content
Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations
By Ivo Eggen , Brian Gregg , Harold Rode , Aleksander Swietlow , Michael Verlander , Anita Szajek
USP evaluates raw materials used in the chemical synthesis of peptides.
Formulation
Drug Encapsulation for Patient-Centric Dosing
By Joan FitzPatrick
Encapsulation technologies for solubility/bioavailability enhancement, controlled release, and formulation of drug combinations and patient-friendly dosage forms.
Navigating the Regulatory Landscape of Combination Products
By Adeline Siew, PhD
Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.
Tackling challenges in the development of fixed-dose combinations
By Adeline Siew, PhD
Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.
Peer-Reviewed
Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze Drying
By Geoff Smith , Trevor Page , Muhammad Sohail Arshad , Eugene Polygalov , Kazem Nazari , Julian Taylor , Irina Ermolina
A new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.
API Synthesis & Manufacturing
Appropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
By Cynthia Challener, PhD
Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.
Troubleshooting
Evaluating the Sterile Barrier of Complex Drug Delivery Systems
By Oliver Stauffer , Heinz Wolf
Methods of validating and assuring container closure integrity are crucial for quality assurance.
Outsourcing Outlook
Biopharma Outsourcing Activities Update
By Eric Langer
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Regulatory Watch
FDA and Manufacturers Seek a More Secure Drug Supply Chain
By Jill Wechsler
New identifiers and tracking requirements aim to block illegitimate products.
Quality by Design—Bridging the Gap between Concept and Implementation
By Sean Milmo
As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.
Global Feature
Global Instability Affects the Pharma Market in Brazil
By Hellen Berger
How badly is Brazil's pharmaceutical market suffering from the global instability of emerging markets?
Drug Discovery
Drug Discovery Partnerships between UK CROs and the Swiss Pharma Sector
By Faiz Kermani
The international pharmaceutical industry is changing its approach to R&D and is increasingly relying on outsourcing for drug discovery.
From The Editor
Publishing Beyond the Printed Page
By Rita Peters
More media options open publishing opportunities for drug development experts.
Ask the Expert
The Benefits of eClinical Systems in Supply-Chain Management
By Kurt Lumsden
Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses eClinical supply-chain management.
Industry Leaders: Q&A
Q&A with Graham Reynolds, West Pharmaceutical Services
By Melanie Sena
Graham Reynolds of West Pharmaceutical discusses glass versus plastic packaging.
Product Spotlight
Multirobot Offline Programming Software Allows 3-D Simulation
By Melanie Sena
Multirobot Offline Programming Software Allows 3-D Simulation
CLARiSUITE Software Improves Accessibility and Productivity
By Melanie Sena
CLARiSUITE Software Improves Accessibility and Productivity
SyncOperations Software Helps Increase Workflow
By Melanie Sena
SyncOperations Software Helps Increase Workflow
Arc View Handheld Mobile Sensor Enhances Measurements
By Melanie Sena
Arc View Handheld Mobile Sensor Enhances Measurements

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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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