Smart Manufacturing Meets the Bioreactor: Driving More Value and Consistency from Bioprocessing

Bioreactor processes in pharma manufacturing include some of the most evolving and complex technologies available in the production of mRNA, plasmid DNA, monoclonal antibodies and a multitude of other vaccine types and medicinal products. The urgent demand for vaccine development and manufacturing due to COVID-19, all while maintaining controlled strategies, has placed immense pressure on bioreactor operations to increase yield with less risk and waste.

To this end, pharma manufacturing teams have been mandated with improving bioreactor process consistency, maximizing productivity, and increasing right first time (RFT) critical process parameters (CPPs). Teams also need the ability to accurately modify and control process parameters to achieve tailored products to specific requirements and the quality target product profile (QTPP).

The complexity of bioreactor data that influence these KPIs — which include hundreds of simultaneous parameters — poses significant analytical and data management challenges. This requires a new approach to optimize actionable steps and to alarm operators of deviations or anomalies. The Aizon Bioreactor Application is the industry’s first AI-driven analytical and GxP data management application designed specifically for bringing smart manufacturing to the bioreactor.

Register for this webinar to hear about:

• Bioreactor yield prediction and optimization, with powerful automated AI options and phased contextualization, tuned specifically for delivering relevant bioreactor intelligence for value return
• Deep process knowledge and batch optimization, including accelerated root cause analysis (RCA) and suggested actions for batch redirection
• Advanced anomaly detection for prediction of issues and potential failures, allowing operating engineers to react before the problems occur, and scale this capability to any number of sites
• Management of bioreactor data to preserve GxP compliance and accessibility under FAIR and ALCOA+ principles

Panelists will also discuss how the bioreactor analytics are compatible with continuous manufacturing as a seamless path for future Pharma 4.0 initiatives.

Speakers

Raul Alba, PhD, PMP, Biotech Solutions Expert, Aizon

Raul Alba is a scientist and project manager with a great interest in the manufacture of biologics and advanced therapies (ATMP). He has a bachelor’s degree in Biotechnology and holds a PhD in Biochemistry and Molecular Biology from the Universitat Autònoma de Barcelona. He has participated in different projects as a postdoc at the University of Glasgow and he has written publications concerning the biodistribution and genetic engineering of viral vectors.

In addition, he holds patents concerning new technologies for the development of novel tools for the gene therapy field. Alba has worked as Head of Virology and CMC Manager for the manufacture of different drug products and advanced therapies, as well as coordinated their manufacture with different CMOs for clinical trials.

Alba joined Aizon in 2020 as a Biotech Expert supporting the Product Development team to generate solutions which help pharma and biotech companies to apply AI in their processes. He guides customers to acquire knowledge which accelerates the process development of their products and increase the efficiency of existing manufacturing lines.

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Crystal Black, VP of Marketing, Aizon

Crystal is the VP of Marketing for Aizon owning and directing the marketing strategy for Aizon’s award-winning AI-informed data analytics solutions for the life sciences industry.

Crystal has been driving global marketing programs in the high tech space for over 2 decades and supporting data and analytics in the pharma space for 4 years. She earned a B.A. and an M.A. from Virginia Polytechnic Institute and State University and is a talented nature photographer and Jeep enthusiast.

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