Search results for " safety" in Articles / App Notes
Article
Downstream Processing for Cell-Based Therapies
A biological safety cabinet usually is needed for the subsequent resuspension step, which involves discarding spent medium and resuspending in a suitable buffer. This process may be repeated multiple …
Article
Accelerated flavivirus vaccine production with modern tools and solutions
Single-use production bioreactors and chromatography purification columnsmitigate cross-contamination risk and support increased operator safety, while reducing time to market by eliminating costly an…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
According to Jason Schuman, a senior product specialist at Cytiva, Biacore is used to screen hybridoma lysates for selection of lead candidates, to measure binding properties, and to evaluate safety, …
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Managing Risk in Raw Material Sourcing
…r bulk pharmaceutical excipients) guidelines to continuously improve our systems and ensure quality, safety, and functionality of pharmaceutical excipients,” says Ohri.
Guiding supplier selection…
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Advancing Single-Use Technology Through Collaboration
…(ASTM) International, BPOG, the Bio-Process Systems Alliance (BPSA), the Extractables and Leachables Safety Information Exchange (ELSIE), the International Society for Pharmaceutical Engineering (ISP…
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Defining Risk Assessment of Aseptic Processes
…ing it are properly maintained at all times to avoid product contamination that would impact patient safety.
Developing a risk-based approach
The first step in developing a risk-based approac…
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Establishing Acceptance Criteria for Analytical Methods
Generally, to control the quality of a product and to manage drug safety and efficacy, there are two key elements: cinical trials evaluting the pharmacokinetics (PK) response to drug product and dose …
Article
A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
…d approach to evaluating single-use system components and conduct supplemental testing to ensure the safety of their process systems.
Did you see any trends in the consumables segment?
The qu…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Vaccine Development Faces Urgency and Challenges
Meanwhile, testing continues on Ebola vaccine candidates that have produced evidence of safety and efficacy from “emergency use” and initial clinical studies. Merck announced advanced clinical trials …