Search results for "Science" in Articles / App Notes
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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…
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Transformative Medicines Challenge FDA and Manufacturers
…ymphoblastic leukemia; this approval was followed by Yescarta (axicabtagene ciloleucel) from Gilead Sciences and Kite Pharma for broader treatment of a similar lethal condition. Spark Therapeutics’ L…
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From Darwin to Recombinant Fc Multimers
Before the final session, Professor Brian Smith, from Pragmedic, UK, presented the focus lecture titled "Darwin’s Medicine: How Business Models are Evolving in the Life Sciences Industry." In h…
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Critical Quality Attributes Challenge Biologics Development
With the advancement of knowledge in analytical sciences, protein engineering, biology, and cell-culture process, it is now possible to assess quality attributes more objectively than before. The awar…
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Automating Bioprocesses
BioPharm International spoke with Michalle Adkins, director of Life Sciences Consulting, and Bill Smizaski, vice-president of Global Life Sciences Operations, both at Emerson, about considerations for…