Search results for " control"
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Article
Quality Considerations for Using AI in Bio/Pharma
Schniepp, distinguished fellow at Regulatory Compliance Associates, stresses that a robust quality management system and document control are necessary when adding AI to a process. “I also worry about…
Webcast
Webinar: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
A streamlined control strategy for AstraZeneca’s development of ICB to test this implementation for 14 days of continuous end-to-end process operation at the clinical manufacturing scale will be prese…
Article
Moving Biosimilars Forward in a Hesitant Market
“As mentioned earlier, [companies] have to provide much more CMC [chemistry, manufacturing, and controls] data for biosimilars compared to the innovator, and that takes time. [Companies] have to estab…
Article
Bracing for a Future Wave of Advanced Therapies
In preparing for the future, ARM and FDA will be looking at streamlining CGT development and
manufacturing, collaborating on complex chemistry, manufacturing, and controls issues, improving soc…
Article
Report from the 6th International HTPD Conference
Further studies will focus on feedback controls, but will also evaluate similar nanosensors for other applications, such as oxygen uptake measurements in cells during culture.
An insightful pan…
Webcast
Trace metals getting you down? Learn what’s really in your cell culture media with Cytiva.
So, how can you be sure these impurities are controlled?
Trust the raw material characterization program at Cytiva. We designed it to give insight into the types and quantities of impurities present…
Article
Trace metals getting you down? Learn what’s really in your cell culture media
So, how can you be sure these impurities are controlled?
Trust the raw material characterization program at Cytiva. We designed it to give insight into the types and quantities of impurities pr…
Article
A Look into Biologic Scale-Up Strategies
To maximize cell-culture output, strategy is required that takes into consideration factors such as cell culture media, environmental monitoring, and process controls. Yet, despite decades of process …