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PharmTech Europe

Increased Efficiency Key to Competitiveness in Downstream Bioprocessing
Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.
Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations
USP evaluates raw materials used in the chemical synthesis of peptides.
Drug Encapsulation for Patient-Centric Dosing
Encapsulation technologies for solubility/bioavailability enhancement, controlled release, and formulation of drug combinations and patient-friendly dosage forms.
Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze Drying
A new process analytical technology based on impedance spectroscopy has potential applications for characterizing product attributes during the freeze-drying process.
Navigating the Regulatory Landscape of Combination Products
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.
Evaluating the Sterile Barrier of Complex Drug Delivery Systems
Methods of validating and assuring container closure integrity are crucial for quality assurance.
Appropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.
PHARMTECH EBOOK SERIES
Analytical and Bioanalytical Testing
View case studies of chromatographic, spectroscopic, and imaging methods used in the identification, characterization, and quantification of drug substances products.

Expert Interviews, Industry Trends, and more

USP Supply Chain Safety Videos
Peer-Reviewed Articles
Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze Drying
Comparing Drug Layering and Direct Pelletization Processes
A New Approach to Forced Degradation Studies Using Anhydrous Conditions
Determination of Related Substances in Pemetrexed Disodium (Form-IV) in Bulk Drug Samples by HPLC
Qualifying Personnel to Visually Inspect Cleaned Equipment
Breaking News
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Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
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Industry Leaders: Q+A
Q&A with Graham Reynolds, West Pharmaceutical Services
Graham Reynolds of West Pharmaceutical discusses glass versus plastic packaging.
Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
20%
Attracting a skilled workforce
28%
Obtaining/maintaining adequate financing
12%
Regulatory compliance
40%
View Results
Standards & Regulations
EMA Sends Roche Findings to European Commission
EMA sends its results on Roche investigation of pharmacovigilance non-compliance to the European Commission.
Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations
USP evaluates raw materials used in the chemical synthesis of peptides.
The Benefits of eClinical Systems in Supply-Chain Management
Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses eClinical supply-chain management.
FDA and Manufacturers Seek a More Secure Drug Supply Chain
New identifiers and tracking requirements aim to block illegitimate products.
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
EVENTS
Apr 23, 2014 - Apr 25, 2014
15th Annual Computer and Software Validation Forum
Apr 28, 2014 - Apr 30, 2014
ISPE Europe Annual Conference 2014
May 4, 2014 - May 8, 2014
Respiratory Drug Delivery (RDD) USA 2014
May 8, 2014 - May 14, 2014
Interpack 2014
May 19, 2014 - May 21, 2014
2014 AAPS National Biotechnology Conference
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