Faster, smaller, smarter: intelligent manufacturing of mRNA through the power of process analytical technologies

Wednesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

Sponsor

Faster, smaller, smarter: intelligent manufacturing of mRNA through the power of process analytical technologies

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

The RNA-based therapeutics and vaccines space is expanding rapidly in application, including novel therapeutics and cancer vaccines, and protein replacement and gene editing approaches. It is crucial that manufacturing technology does not create a bottleneck on innovation and hamper the continued evolution of the space.

Process analytical technologies (PAT) allow the measure and control of production processes in real time, to ensure final product quality and accelerate timelines. The use of inline analytics can negate the broad use of offline assays that gate and stifle traditional batch manufacturing. ReciBioPharm (RBP), a leader in the ATMP CDMO space, received an award from MIT to collaborate on a fully integrated, digitally controlled xRNA manufacturing process that will significantly shift development times from 9-12 months to just 2-4 months. This will condense cGMP manufacturing from IVT to fill-finish down to a single day.

This powerful platform couples a robust data set with cutting-edge PAT and inline analytics. Through multiplexing a number of PAT devices, extensive data gathering, and modelling, predictive models can be created and CQAs can be monitored in real time. Attend this webinar for insights on how PAT can predict and monitor CQAs related to IVT including RNA concentration and nucleoside triphosphate consumption, along with RBP and MIT’s plans to further develop this technology in order to change the future of biomanufacturing.

The benefits of integrating PAT within mRNA manufacture
How to achieve support for continuous and more effective manufacturing of mRNA with predictive models to monitor CQAs in real time
The benefits of a single digital infrastructure to simplify and streamline mRNA manufacture

Aaron Cowley

CSO at ReciBioPharm

Aaron B. Cowley (PhD in Chemistry/MBA) is the Chief Scientific Officer at ReciBioPharm, formerly known as Arranta Bio (2019-Present; the biologics division of ReciPharm, a top-7 CDMO globally with nearly +5200 employees). ReciBioPharm is a leading CDMO focused on Advanced Therapy Medicinal Products (ATMP), including but not limited to Live Biotherapeutic Products (LBPs), xRNA, Viral Vectors, Enzymes and pDNA. Prior to joining Arranta Bio, Aaron was the co-founder and the Chief Technical Officer of Captozyme (2009-2019; Gainesville, FL), an emerging biotechnology and service-based company that was acquired by Arranta Bio in 2019. Aaron was also a founding member and Board Member of a small biotechnology company, Oxidien Pharmaceuticals, developing therapeutic enzymes that was acquired in 2023. Aaron is a Chemist, with a focus on redox potentiometry and its impact on the function of enzymes both in vitro and in vivo. His work has resulted in numerous publications, patents, grant funds and private/venture capital funding. He spearheads the vision and execution of the continuous manufacturing platform being developed for xRNA at ReciBioPharm as part of the funding awarded by the FDA to MIT. Lastly, Aaron is one of the founders and participating members of the MIT Center of Continuous mRNA Manufacturing.

Edita Botonjic-Sehic

Senior Director, Process Sciences at ReciBioPharm

Dr. Edita Botonjic-Sehic is a Head of process analytics and data science at ReciBioPharm where she provides technical insight and strategic conceptualization and implementation of process analytical technology (PAT), data engineering and data science for the continuous bioprocessing; she brings more than 20 years of experience in advanced process analytical technologies and data science techniques improving manufacturing concepts in pharmaceutical and therapeutics development.

Dr. Edita Botonjic-Sehic was a Director of process analytical technology at Pall Life Sciences and Cytiva leading development of novel technologies. Additionally she was a member of the PAT team within GlaxoSmithKline’s program for API development and she also led a PAT team at TEVA Pharmaceuticals for drug product manufacturing, and was a principal investigator and program manager on several government-funded (DHS, TSWG, CTTSO) projects at Morpho Detection (formerly GE Homeland Security), where she specifically worked on the development of systems for trace and bulk materials detection.

Dr. Botonjic-Sehic completed her PhD in Analytical Chemistry at the University of Rhode Island after undergraduate studies at Assumption College in both chemistry and mathematics and recently has completed business analytics program at Harvard Business School. She is a respected leader in her field and an accomplished author of numerous papers, and frequently delivers talks in the field of advanced technologies.