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Pharmaceutical Technology-04-02-2015
Pharmaceutical Technology
Evaluating Package Integrity
April 02, 2015
Packaging Forum
39
4
Industry awaits the final revision of USP General Chapter and the impact it will have on the evaluation of sterile product package integrity.
Designing Trouble-Free Freeze-Drying Processes
April 02, 2015
Troubleshooting
39
4
Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.
Modernizing Scale-Up
April 02, 2015
Featured Content
39
4
Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.
Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment
April 02, 2015
Featured Content
39
4
In-silico design facilitates process optimization and evaluation of process control strategies.
Meissner Biocontainer Increases Customizability
April 02, 2015
Product Spotlight
39
4
Meissner’s TepoFlex is a polyethylene biocontainer designed for secure handling and it is part of the One-Touch single-use systems portfolio.
Ross Discharge System Increases Efficiency
April 02, 2015
Product Spotlight
39
4
Ross’ Discharge System with Electronic Pressure Control is designed for use with Ross Planetary Mixers and Multi-Shaft Mixers.
West Vial Seal Reduces Risk of Contamination
April 02, 2015
Product Spotlight
39
4
West Pharmaceutical’s sterile drug vial seal, the Flip-Off Plus, is manufactured using a production process that provides precise, consistent, and reproducible seals.
Quattroflow Diaphragm Pump Ensures Product Containment
April 02, 2015
Product Spotlight
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4
Quattroflow’s QF1200CV is a compact quaternary diaphragm pump designed for tabletop and cleanroom applications.
Industry Expert Q&A with David Barrett
April 02, 2015
Industry Leaders
39
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David Barrett, chief operating officer at cut-e, discusses The Behavioral Positioning System.
The Role of Regulatory Advice in Drug Development
April 02, 2015
Regulatory Watch
39
4
Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?
Will Advances in Controlled Release Open Up New Drug Delivery Opportunities?
April 02, 2015
Featured Content
39
4
Emerging controlled-release technologies could lead to more effective therapies in the near future.
The Human Microbiome Project and Pharmaceutical Quality Control Microbiology
April 02, 2015
Peer-Reviewed Research
39
4
The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.
An Orthogonal Approach to Biosimilarity
April 02, 2015
Featured Content
39
4
In this article, industry experts discuss critical analyses for demonstrating biosimilarity.
Predicting Meaningful Process Performance
April 02, 2015
Featured Content
39
4
Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.
FDA Steps Up Foreign Inspections
April 02, 2015
Featured Content
39
4
New legislation and changes in policy at FDA are leading to better control of the API supply chain.
Welcome to the Biosimilar Era
April 02, 2015
From The Editor
39
4
FDA approves a biosimilar and loses a commissioner in March.
Modern Manufacturing Systems Key to FDA Quality Initiative
April 02, 2015
Regulatory Watch
39
4
More reliable operations would accelerate product development and prevent drug shortages.
Drug Discovery and Development in India
April 02, 2015
Global Market Report
39
4
Hope abounds for local drug discovery companies despite challenges at home.
More Evidence that Size Matters
April 02, 2015
Outsourcing Outlook
39
4
Big service providers get bigger faster thanks to Big Pharma.
Multivariate Data Analysis Finds Use In Biopharmaceutical Process Development And Scale-Up
April 02, 2015
39
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Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.
Pharmaceutical Technology, April 2015 Issue (PDF)
April 02, 2015
Issue PDF
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Click the title above to open the Pharmaceutical Technology April 2015 issue in an interactive PDF format.