Search results for " specification" in Articles / App Notes
Article
3rd BioProcessing Asia Preview: Q&A with John Curling
The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Bioprocess Development Forum talks with John Curling, Conference Chair, about the upcomin…
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Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
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QbD Improves Cell-Culture Process Control
The goal of MPC is to meet various CQA specifications by manipulating process inputs while also taking into consideration process constraints.
Reference
1. W. Sommeregger et. al, “Quality by C…
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Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
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Concentration and Buffer Exchange Using the Automated, Single-Use ÄKTA™ readyflux System
This work describes the capabilities of ÄKTA readyflux when used in ultrafiltration/diafiltration (UF/DF) applications. The process was conducted in an automated manner based on methods created …
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Participants explored strategies for analytical method development, assay validation, product characterization, specification setting, and for establishing relevant manufacturing controls for these hi…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
This week Process Development Forum talks about Protein A with Jonathan Royce, business leader for Cytiva chromatography resins.
mAb purification platforms are very well established, and …
Article
Will My Buffers Work When Using an Inline Conditioning System?
Buffer preparation can be both time and space consuming and can easily become a challenge in biomanufacturing. In-line preparation of buffers from highly concentrated, single-component stock soluti…
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Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…
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The New World of Biopharmaceutical Manufacturing
…rtificates, manufacturing practices, and product lifecycle management aspects (from user requirement specifications to management of supplier change notifications post-implementation). The establishm…