Search results for " guide" in Articles / App Notes
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Electronic or paper procedures that guide shop floor people through all of the steps are key to ensuring fast and error-free changeovers, particularly when combined with MES, electronic batch record s…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Specific factors to assess for possible impurities include requirements established in regulatory guidelines, acute and chronic toxicity, risk of co-purification, and natural occurrence in humans, acc…
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Good Manufacturing Practices: Challenges with Compliance
While generally easy to understand, the interpretation of the guidelines, especially when there is room for flexibility, can create the potential for challenges.
Having an effective feedback loo…
Article
The Importance of Partnering for Bioanalytical Studies
Pharmacokinetic (PK) scientists use the data to determine exposure, half-life, and other pharmacological parameters, which are used to guide decisions on how often and how much of a therapeutic should…
Article
Gene Therapies Push Viral Vector Production
He highlights the fact that some innovators are using guide RNA with an endonuclease (e.g., Cas9) to modify cells ex vivo and make the edits. “I expect we’ll see some products approved in the future u…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioproc…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
The Need for Advanced Process Modeling for New Therapeutic BiologicsThe trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling e…
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Addressing the Complex Nature of Downstream Processing with QbD
However, for later stage and commercial, we employ detailed risk assessments based on FMEA [failure modes and effects analysis] concepts to guide the needed studies and scope of work. These risk asses…
Article
Supply Chain Challenges for Single-Use Systems
Isberg (Entegris): I always refer people to the BPSA quality test matrices guide (5), which is an excellent resource for quality testing for single-use systems for bioprocessing applications.
Bulp…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…