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Pharmaceutical Technology-07-02-2019
Pharmaceutical Technology
Playbooks Are Not Just Child’s Play
July 02, 2019
Ask the Expert
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Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
New Line of Rotary Valves
July 02, 2019
Product Spotlight
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Gericke USA’s RotaVal line of rotary valves discharge powders from hoppers, fill process machinery, dose from silos, and isolate pneumatic conveying zones between sifters, mixers, screw conveyors, and other equipment.
Planetary Dual Dispersers and Advanced Discharge Systems
July 02, 2019
Product Spotlight
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The Planetary Dual Disperser is the newest addition to the Ross planetary mixing line of industrial mixers.
Updated Pump Head
July 02, 2019
Product Spotlight
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The Masterflex L/S Easy-Load pump head from Cole-Parmer has an updated design and enhanced features for greater ease of use.
FDA Revamps Biosimilar Quality Requirements
July 02, 2019
Regulatory Watch
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New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
Plate Reader Offers Real-Time Detection and Analysis
July 02, 2019
Product Spotlight
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Tecan’s Spark Cyto cell plate reader offers real-time detection and analysis of biological, chemical, and physical events while consistently capturing the maximum amount of data from every well.
Automating Quality Checks
July 02, 2019
Features
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Today’s inspection systems catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.
Considerations for Sterile Filtration of Biologic Drugs
July 02, 2019
Features
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Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
Improving Prospective Product Development Methods Derived from Management-Based Regulatory Guidelines
July 02, 2019
Peer-Reviewed
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To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.
Gene Therapies Propel Outsourcing Investment
July 02, 2019
Outsourcing Outlook
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The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.
A Biologics Partisan Divide
July 02, 2019
From The Editor
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FDA and USP take sides in debate on biologic drug standards.
Clarifying Industry’s Concerns Over Regulation of Drug Device Combinations
July 02, 2019
Regulatory Watch
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Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?
Putting Endotoxins to the Test
July 02, 2019
Features
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This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.
A Wellcome Result for Science
July 02, 2019
From The Editor
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The Wellcome Global Monitor has demonstrated an overall positive trust in science but some concerns still remain on attitudes on vaccines.
Selecting a Solid Approach
July 02, 2019
Features
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Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.
Facilitating API Delivery with Nanoscale Solutions
July 02, 2019
Features
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Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.
Removing Gaps in Data Integrity
July 02, 2019
Features
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FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.
Is it Time to Update cGMPs?
July 02, 2019
Cover Story
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Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?
Can Bioprocessing Achieve Digital Transformation?
July 02, 2019
Features
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Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.
Pharmaceutical Technology North America, July 2019 (PDF)
July 02, 2019
Issue PDF
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Click the title above to open the Pharmaceutical Technology July 2019 issue in an interactive PDF format.