August 02, 2021
Cover Story
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The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages.
August 02, 2021
Development
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Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.
August 02, 2021
Development
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Growing demand for bispecific antibodies increases the need for automated and miniaturized high throughput screening capabilities.
August 01, 2021
Downstream Processing
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Automation is one asset that benefits cell harvesting by cutting out laborious manual steps and minimizing contamination.
August 01, 2021
Manufacturing
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Through the adoption of single-use technology, drug manufacturers have been able to adapt to the challenges posed by the COVID-19 pandemic.
August 01, 2021
Manufacturing
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Scenario modeling informs planning for current and future manufacturing needs.
August 01, 2021
Analytics
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Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.
August 01, 2021
Outsourcing
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Manufacturers should consider the benefits and risks of contract packaging for stability studies.
August 01, 2021
Regulatory Beat
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Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.
August 01, 2021
From the Editor
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Congress questions FDA on plans to catch up and move forward with facility inspections as pandemic travel restrictions ease.
August 01, 2021
Ask The Expert
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Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.
August 01, 2021
Product Spotlight
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Syntegon's Syringe Inspection Line utilizes an AI vision system for the inspection of syringe flanges, stoppers, and cylinders.
August 01, 2021
Product Spotlight
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The Cytomat 24 automated incubator system is designed for large-capacity microplate processing.
August 01, 2021
Product Spotlight
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SP Scientific's SALS30 and RxR-36 are designed for fill/finish processing applications like freeze dryers.
August 01, 2021
Product Spotlight
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Eppendorf's CryoCubeF440 freezer has been redesigned to promote sustainability through various green features.