Search results for " process development"

Article Mixed-Mode Chromatography in Downstream Process Development
Several approaches for intermediate purifications were tested during process development. Reversed-phase chromatography under strongly acidic conditions worked well for purification of research-grade …

Article Tackling Analytical Method Development for ADCs
process, according to Davidson, and only a few methods may be required to support early conjugation process development, for example, SEC for aggregation, HIC for DAR, and RPC for free drug. Once th…

Article Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability. Sep 2, 2014 By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…

Article Developing a mAb aggregate removal step by high throughput process development
By Gustav Rodrigo and Kristina Nilsson-Välimaa ABSTRACT This article presents a case study illustrating the benefits of using a high throughput process development (HTPD) approach for choice o…

Article Applying GMPs in Stages of Development
Applying GMPs in Stages of Development Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …

Article Techniques for Improving Process Development for Exosome-Derived Therapeutics
Here, the Process Development Forum speaks with Aaron Noyes, Head of Downstream Processing, at Codiak BioSciences about exosomes, their potential clinical applications, and process innovations that wo…

Article Design of Experiments for Analytical Method Development and Validation
Design of experiments (DOE) is a well-proven characterization approach within product and process development and a key aspect of quality by design. Recently, more attention has been placed on applyin…

Article Can Vaccine Development Be Safely Accelerated?
Can Vaccine Development Be Safely Accelerated? Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe. By Cynthia A. Cha…

Article High-Throughput Process Development in an Historical Environment
HTPD approaches in downstream goes beyond chromatography The approaches in downstream process development, with screening of chromatography resins and parallel screening of optimal process conditi…

Article New ReadyToProcess WAVE 25 Bioreactor Provides Advanced Control in Research, Process Development, and Manufacturing Operations
Annerén, growing interest from the process development community in the newer bioreactor. “Because it is so easy to adjust a wide variety of process parameters and monitor the changes in the culture c…

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