Search results for " design" in Articles / App Notes
Article
How to program, run and evaluate a design of experiments (DoE)
You’ll learn how to program, run, and evaluate a design of experiments (DoE) run. An application example showcases how to optimize an antibody purification for low dimer-and-aggregate and host cell pr…
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Quality by design in biotherapeutics purification white paper
Learn how understanding and addressing variability sources can help you develop robust chromatography processes. The principles and methodologies of biopharmaceutical manufacturing are well …
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Is Your Single-Use Facility Designed with the End in Mind?
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Up-front design considerations can improve your long-term processing flexibility and ability to expand.
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Purposeful Design and Development of a Next Gen Single-use Bioprocess Film
Fortem film is purposefully designed and developed with a carefully selected raw material, incorporating advanced manufacturing technology with an overarching focus on transparency along the entire su…
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Purposeful Design and Development of a Next-Generation Single-Use Bioprocess Film
Fortem™ is purposefully designed with a carefully selected raw material, incorporating advanced manufacturing technology with an overarching focus on transparency along the entire supply chain.
Cl…
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Designing a 1.5 L Bench-Scale Model of a Perfusion Process
Establishing an appropriate model allows for higher throughput during simultaneous operation and monitoring of several cultures at different process conditions. In this article, we discus…
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Quality by Design in Biotherapeutics Purification: Understanding and Addressing Sources of Process Variability
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The principles and methodologies of biopharmaceutical manufacturing are well established today. However, the increased molecular diversity br…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
The purpose of this assessment is to provide a focus for the downstream process characterization work required to complete process validation Stage 1 (process design).
This initial risk assessm…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
In Part I, the author used risk analysis and applied the continuum of criticality to quality attributes during the process design stage of process validation. After using process kno…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed program for COVID-19 vaccine manufacturing, the US governm…