Critical Environments Featured Articles
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Integrating Design And Industrialization To Optimize Cost, Quality & Time
6/1/2021
Explore how integrating design and industrialization teams can optimize the cost, quality, and time of developing a novel drug delivery system.
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Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm
4/19/2021
Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.
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Tools And Best Practices For Trending Environmental Monitoring Data
4/11/2021
Environmental monitoring (EM) trending is an essential component of the EM program to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure establishment of an efficient environmental monitoring program.
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An Introduction To Trending In Environmental Monitoring Programs
4/5/2021
Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM.
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Improve Bioprocessing Efficiency With A Standardized Automation Platform
3/9/2021
Designed specifically for the biomanufacturing industry, this portfolio of automation platform solutions simplifies engineering management, improves data management, and reduces process risk.
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Integrated Manufacturing: Chromatography Meets Predesigned DeltaV
3/9/2021
Cytiva’s pre-defined automation solution, Figurate, is now available as a turnkey solution by combining our industry-leading ÄKTA process chromatography system with the reliability of the DeltaV DCS platform.
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Achieving Business Continuity In Pharma During COVID-19 Restrictions
3/4/2021
To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.
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Preparing For Future Viral Vector Manufacturing Technologies And Platforms
3/1/2021
Rethinking how we transition from translational clinical centers at smaller scale—using flasks and open systems—towards commercial production and methodologies.
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Future Delivery Models For ATMPs: Practical Considerations
2/17/2021
With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.
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9 Rules For Cleaning Verification & Validation Of Multipurpose API Plants
2/12/2021
Cleaning validation continues to be a hot topic during regulatory inspections and industry discussions. The cleaning required in an active pharmaceutical ingredient (API) plant between one manufacturing process and the next can present a huge challenge, particularly when multipurpose plants are used.