Search results for "Science"
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Moving Biosimilars Forward in a Hesitant Market
There are 45 biosimilars approved in the United States, which represents amazing progress over the past 10 years or so, remarks John Gabrielson, senior vice-president at JSR Life Sciences and head of …
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Top Process Development Trends for 2022 and a Look into 2023
More Hands-on Content, as the Industry Struggles to Keep Up with the Science of novel molecules
In lockstep with increasing molecular diversity, popular content on the Process Development Forum la…
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Report from the 12th Plasma Product Biotechnology Forum
Hence, FDA revised recommendations for certain donor deferrals based on evolving science. With increased knowledge that implemented control strategies, as well as the manufacturing processes, showing …
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What’s in your media? How costly is variability of cell culture media to your manufacturing process?
Joining me today is Christopher Woolstenhulme, lead analytical scientist of manufacturing sciences at Cytiva. Thank you so much for being here today, Let’s begin.
Megan Manzano: What are s…
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Assessing Manufacturing Process Robustness
ICH guidelines Q8–Q12 (1–5) and those in development such as ICH Q14 (6) have applied science, risk management, and quality systems to enhance process and product quality.
In 2011, …
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Setting Up Bioprocessing Systems for Digital Transformation
Bob Lenich, director of global life sciences at Emerson, says that manufacturers are well aware they will be audited, and thus recognize the need to have strict compliance in place. The challenge here…
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Good Manufacturing Practices: Challenges with Compliance
…irector of quality, Catalent; Judy Cohen, vice-president of Quality and Regulatory at Lubrizol Life Science’s CDMO Division; and Dino Muzzin, senior vice-president of manufacturing operations at Emer…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
There should also be an emphasis on product understanding and process control, and that the design of a process should be grounded in “sound science” and quality risk management (1).
FDA has no…
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Mapping a Route for Cell and Gene Therapy Process Development
And importantly, the science of bioreactor scaleup is better understood and generally requires few process changes,” he explains.
For gene therapies, advances in analytical techniques designed …
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Cell-Culture Advances Test Bioreactor Performance Models
…predictive models can enable these variation reductions,” asserts Tom Mistretta, director of data sciences at Amgen.
The continual development of higher-producing cell lines, the switch to chem…