Complimentary Webinar Registration:
About Our Speaker:
Don Ornek, Ph.D.
Senior Director, Process Development and Manufacturing, CuriRx,Inc
Abstract: Gene therapy is a fast-growing industry. Though demand for its products, including pDNA, AAV, retrovirus, lentivirus, and others, has significantly increased over the last 10 years, production challenges have remained unresolved. Gene therapy is a complex process with several unoptimized and low yielding steps. A typical process development (PD) cycle, from preclinical to manufacturing (MFG) takes 3 to 4 years. CuriRx has implemented the following strategies to accelerate process development, thereby enabling more rapid advancement of early clinical candidates to manufacturing:
(1) A platform approach for early stage process development
(2) Efficient DoE application for process optimization and characterization
(3) Enhanced approach between PD and MFG for streamlined scale-up, tech transfer, and manufacture support
(4) Development of a new PAT tools application to better understand the process design space, therefore developing a control strategy
Details of these strategies, including case studies demonstrating optimized high-yielding gene therapy processes, will be covered in this webinar.