Search results for " production"
Article
Gowning Practices Provide Clues to cGMP Compliance
decentralized
Is gowning centralized or decentralized? Centralized gowning, occurring as part of the entry to a specific production area, although not a guarantee, is indicative of organized and o…
Article
Comparing Protein A Resins for Monoclonal Antibody Purification
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic and research uses, antibody titers in mammalian cell culture have increased dramatically over the past 20 years. …
Article
Operational Excellence: More Than Just Process Improvement
The absence of a QA presence coupled with the perception by shop floor personnel that QA auditors were adversaries who simply policed production were principal underlying causes of the compliance prob…
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PDA's Technical Report for Biotech Cleaning Validation
This article is the twenty-second in the "Elements of Biopharmaceutical Production" series and will discuss the various issues to consider when designing a cleaning-validation program.
CLEANING PR…
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What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Manufacturing
In this video, Christopher Woolstenhulme, Lead Analytical Scientist of Manufacturing Sciences at Cytiva, is interviewed by BioPharm International and provides insight into t…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
It really boils down to having rugged instruments that perform well in an environment that's being sprayed down with water and part of a cadence—that's the whole point of doing stuff in production and…
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Cytiva Advances Fiber Chromatography Technology with New Launch
The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.
On Jan. 27, 2021, Cyti…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Workflows, capital and operating expenses, product quality, and waste production can all be positively impacted by the efficiency gains possible with process intensification.
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Leveraging Computational Models of Glycosylation for Biopharma QA
…inese hamster ovary (CHO) and murine myeloma (NS0 and Sp2/0) cell lines being the most-commonly used production platforms (5). During cell culture, even subtle variations in nutrient availability, di…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
of Rockville, MD, has surveyed developers of biotherapeutics and contract manufacturing organizations working in this space about current and projected capacity and production. The results, published …