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Pharmaceutical Technology-04-02-2021
Pharmaceutical Technology
Advanced Manufacturing Technologies Shift Outside the Box
April 03, 2021
Cover Story: Manufacturing Trends
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Intensified and distributed manufacturing approaches create flexible, local capacity.
Reshoring and Expanding API Manufacturing Capabilities
April 03, 2021
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Manufacturers in Europe and the United States have announced plans for new in-country API development and manufacturing capabilities.
Comparing Methods for Determining Out-of-Trend Stability Test Results
April 03, 2021
Peer-Reviewed Research
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This article describes in detail how simulation was used to compare the statistical techniques used to determine out-of-trend (OOT), which is crucial to avoiding out-of-specification (OOS) events for drug substances and products.
Balancing the Art and Science of Topical Drug Formulation
April 03, 2021
Development
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Topical drugs are attractive to patients, but these complex products pose challenges for formulators.
Focusing on Accelerated Formulation Strategies
April 03, 2021
Development
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Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.
Early-Stage Considerations for the Manufacture and Delivery of Vaccines
April 03, 2021
Manufacturing
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Although vials and prefilled syringes have different advantages, both find use in vaccine fill/finish.
Understanding the Impact of Annex 1 on Isolator Operation
April 03, 2021
Manufacturing
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Decontamination, automation, and containment are important considerations for aseptic manufacturing in isolators.
Reducing Uncertainty of an Analytical Method through Efficient Use of Replication
April 02, 2021
Quality
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A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.
Blocking the Threat of Counterfeit Medicines
April 02, 2021
Quality/Regulations
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After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.
Limitations and Advances in Dissolution Testing
April 02, 2021
Analytics
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Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.
Supply Chain Challenges Creating Hurdles to COVID-19 Vaccine Production
April 02, 2021
Outsourcing
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The availability of materials is a critical factor when it comes to vaccine capacity.
Pressure Mounts for FDA to Ramp Up Drug Inspections
April 02, 2021
Regulatory Watch
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Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.
Avoiding Unforced Errors in the Bio/Pharma Industry
April 02, 2021
From The Editor
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Smart, accurate, science-based messaging is needed to advance bio/pharma science.
A Watchful Eye on Pharma: Promising Drugs and Changing Bio/Pharma Landscape
April 02, 2021
From The Editor
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COVID-19 has placed bio/pharma in the spotlight of global media, but away from vaccines there are other prospective pipeline treatments that will be worth watching.
Frequently Asked Questions on Deviations
April 02, 2021
Ask the Expert
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Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding deviation investigations.
Peristaltic Pump for Biopharmaceutical Applications
April 02, 2021
Product Spotlight
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High Purity New England launched the VerderFlex Vantage 5000 peristaltic pump for medium flow at low to medium pressures in biopharmaceutical applications.
Triple Shaft Mixers
April 02, 2021
Product Spotlight
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Triple Shaft Mixers from ROSS are designed to adapt to various viscous applications requiring hygienic and sanitary handling.
Wrap-around Labeler with Continuous Labeling Capabilities
April 02, 2021
Product Spotlight
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HERMA US announced it now includes continuous labeling capabilities for its 132M HC Wrap-around Labeler.
Miniature Smart Sensors
April 02, 2021
Product Spotlight
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SICK introduced the SICK W4F line of miniature smart sensors designed to reach next-generation detection performance while including new optical technologies to solve typical pharmaceutical sensing challenges.