Search results for " development" in Articles / App Notes
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Expanding the development and use of best practices and consensus-based standards for obtaining and maintaining authenticated and contaminant-free cell lines should also include smaller repositories, …
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Modern Manufacturing Systems Key to FDA Quality Initiative
She reiterated this approach at the February 2015 annual meeting of the Generic Pharmaceutical Association, urging development of continuous manufacturing operations that can achieve consistent produc…
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SEC in the Modern Downstream Purification Process
Despite the relative predictability of SEC separations, method development at small scale is crucial to ensure a smooth transition from the bench- to manufacturing-scale operations.
With SEC, it i…
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Viral Clearance Challenges in Bioprocessing
…ult in different performance for individual unit operations compared to that observed during process development. “Understanding the impact of shipping and extended storage on performance and the dev…
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Single-Domain Antibodies for Brain Targeting
Some species have been shown to be active in the intestine after oral application, but their low absorption from the gut impedes the development of systemically active sAbs (22-26). The comparatively …
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Implementing QbD in Sterile Manufacturing
Design review is a decisive milestone within the development process for a single piece of equipment. It is performed through the adjustment of an initially created design with its particular requirem…
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The Lifecycle Change of Process Validation and Analytical Testing
I think material understanding throughout the manufacturing process from the product development phase onwards will not only support a robust commercial manufacturing process but can also reduce the b…
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Sterilization Trends for Single-Use Consumables
11137-1:2006, Sterilization of Health Care Products–Radiation–Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
BPSA. X-Ray St…
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Exosome isolation by tangential flow filtration and size exclusion chromatography
For research and development and diagnostic purposes, ultracentrifugation is an established technology to separate and purify exosomes. However, ultracentrifugation is not easily scalable. We describe…
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Save the date for HTPD 2025
We are pleased to announce the 7th International Conference devoted to High-Throughput Process Development (HTPD) and smart PD, to be held May 26–29 2025 in Uppsala, Sweden.
The program and…