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Pharmaceutical Technology-08-02-2018
Pharmaceutical Technology
Pharmaceuticals in the Environment
August 02, 2018
Regulatory Watch
42
8
Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.
E&L Risk Assessment for Biologic Drug Products
August 02, 2018
Features
42
8
Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets
August 02, 2018
Peer-Reviewed Research
42
8
This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
Exploring a Modern Control Strategy for Wurster Coating
August 02, 2018
Features
42
8
A process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.
Key Considerations in Multilayer Tableting
August 02, 2018
42
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Jean-Yves Balfin, product manager at Korsch AG, speaks to Pharmaceutical Technology about the ins and outs of multilayer tableting.
FDA is Not Playing Games with Biosimilars
August 02, 2018
From the Editor
42
8
Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.
Increasing API Complexity Drives Demand for Cryogenic Capabilities
August 02, 2018
API Synthesis and Manufacturing
42
8
Low-temperature chemistry enables performance of more challenging and selective chemistry.
Benchtop Sample Preparation Station
August 02, 2018
Product Spotlight
42
8
The PrepEngine Mini Sample Prep Station from Distek is suited for assay, impurity, and content uniformity applications.
Single-Use Electromagnetic Flow Meter
August 02, 2018
Product Spotlight
42
8
The Flexmag 4050C Electromagnetic Flow Meter from Krohne is suited for biopharmaceutical applications including filtration processes, chromatography, or buffer and media preparation.
Advanced Paddle Blender for Labs
August 02, 2018
Product Spotlight
42
8
Ross, Charles & Son’s Laboratory Paddle Blender offers advanced features for automated powder blending and liquid spraying operation with recipe management.
AODD Pump Alternative to Plastic Pumps
August 02, 2018
Product Spotlight
42
8
The C-Series air-operated double-diaphragm (AODD) pump from Almatec, part of PSG, a Dover company, is an alternative to similar plastic pumps and is suited for almost any pumping application that uses an oscillating pump.
The Case for Extended Dwell Flat Tooling
August 02, 2018
Features
42
8
Increasing dwell time can improve tablet production.
Submitting Extractables and Leachables Data to Regulators
August 02, 2018
Ask the Expert
42
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The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
Outsourcing Glycan Analysis
August 02, 2018
Features
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Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.
Reducing the Risk of Pharma Air Transport
August 02, 2018
Features
42
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Air transport continues to be the most secure way to ship valuable therapies, but it is also the riskiest. Standards are helping to improve service quality.
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template
August 02, 2018
Features
42
8
A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Modular Manufacturing Can Ease Bioprocessing Woes
August 02, 2018
Features
42
8
Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.
The Challenge of Building Better Biologic Drugs
August 02, 2018
Cover Story
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Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.
Pharmaceutical Technology, August 2018 Issue (PDF)
August 02, 2018
Issue PDF
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Click the title above to open the Pharmaceutical Technology August 2018 issue in an interactive PDF format.
FDA Seeks to Revive Quality Metrics Initiative
July 02, 2018
Regulatory Watch
42
8
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.