Complimentary Webinar Registration:

Strategies to Accelerate Gene Therapy Process Development
from Preclinical to Manufacturing

Date: Thursday, Jan 21st, 2021

Time: 2:00pm ET / 11:00am PT

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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.

Complimentary Webinar Registration:

Strategies to Accelerate Gene Therapy Process Development
from Preclinical to Manufacturing
Date: Thursday, Jan 21, 2021
Time: 2:00pm ET / 11:00am PT