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BIO International Convention 2022

Schedule a Meeting with Catalent at BIO International Convention 2022

Date: June 13-16, 2022
Location: San Diego, CA
Booth: 1227

 

FEATURED PANELIST

 


Vic Vinci

Vice President, Product Development, Catalent Biologics

 

 

Session Title: Current Realities of Make vs. Buy for Cell, Gene and Advanced Therapies Manufacturing
Session Date: Wednesday, June 15, 2022
Session Time: 11:00AM – 12:00PM PT
Description: This panel of leading industry experts will discuss key considerations and experiences related to the Make vs. Buy decision from a variety of perspectives. Speakers will debate whether those considerations are unique to today’s environment and how they might be different in the future. How have the supply chain disruptions post-pandemic affected production? Has prioritization of vaccine manufacturing been a benefit or a challenge to other therapeutic production? What is the impact of de-risking innovative technologies to improve biologics manufacturing in the future? This session will solicit significant audience input to shape the discussion.


 

BPI THEATER @ BIO 2022

FEATURED SPEAKERS

 


Tom VanCott, Ph.D.

Global Head of Product Development, Catalent Cell & Gene Therapy

 

 

BioProcess International Executive Interview
Session Date: Monday, June 13, 2022
Session Time: 1:45PM PT
Location: BioProcess International Theater

Session Title: Platform Processes Accelerating AAV Vector Production from Gene to Clinic
Session Date: Tuesday, June 14, 2022
Session Time: 11:20AM PT
Location: BioProcess International Theater
Abstract: The cell and gene therapy market continues to grow rapidly with new molecules entering clinical trials and many reaching late-stage clinical studies for life-changing therapies for previously untreatable diseases including monogenetic disorders, cancer, and infectious diseases. Adeno-associated viral (AAV) vectors are the primary vector used for the production of viral vector-based gene therapies. As demand for AAV vector manufacturing has grown, so too has the demand for plasmid DNA, a critical component to many advanced therapeutics. Some of the challenges facing cell and gene therapy manufacturing are scalability, the lack of advanced platform processes, and supply chain bottlenecks. During this talk, Catalent’s platform manufacturing processes for plasmid DNA and AAV vectors will be presented, including how they can address these challenges, support early activities, and facilitate the transition towards GMP production for clinical and commercial supply.

    • The features of plasmid and AAV platform processes
    • The advantages of securing plasmid bioproduction services that are fully integrated within viral vector and cell therapy manufacturing capabilities
    • How a platform manufacturing process can accelerate advanced therapies from gene to clinic

 


Greg Bleck, Ph.D.

Vice President of Research and Development, Catalent Biologics

 

 

Session Title: Shortening clinical developments timeline using novel GPEx® Lightning technology for generating stable, high producing cell pools and cell lines
Session Date: Wednesday, June 15, 2022
Session Time: 11:20AM PT
Location: BioProcess International Theater
Abstract: Speed and efficiency remain major drivers for developers bringing their protein-based biologics to first-in-human studies. For 20 years, GPEx® cell line development technology has provided a proven approach to generate high expressing, highly stable mammalian cell lines with 16 commercially approved biologics that have been developed to date. Building off the synergies of GPEx® technology, a glutamine-synthetase knockout, targeted gene insertion and two proprietary concepts, Catalent recently introduced GPEx Lightning, a fast, flexible way to shorten the path to production of cGMP product. During this talk, we share the latest data leveraging GPEx® Lightning to generate highly stable, highly productive cell pools and discuss how the GPEx® suite of technologies can be tailored to the specific needs of each individual program on its path to clinical trials.


 



Jesus Rosales Soto

Sr. Scientist, Oral Formulation Development, Catalent

 

 

Session Title: Rapid Screening of Bioavailability Enhancing Technologies to Accelerate Time to Clinic
Session Date: Wednesday, June 15, 2022
Session Time: 1:05PM PT
Location: BioProcess International Theater
Abstract: There is increasing pressure to improve the productivity and efficiency of the drug development process. This often translates to accelerating formulation development timelines with limited data or material. However, there are API sparing analytical tools available that can help with the assessment of physicochemical properties of the API that can guide the selection of formulation approaches to mitigate various oral bioavailability liabilities of the drug. Technologies such as amorphous solid dispersions, lipid formulations, and particle size reduction can be powerful tools when employed early in the development stages. A scientific expert from Catalent will provide insight into how to navigate issues relating to oral product development and address these challenges early for a successful outcome in preclinical and early-stage clinical studies.

Key learning objectives:

    • Understand how API sparing techniques can help select the right formulation platform technologies
    • Discover the rapid pathway of prototyping to fast track in vitro and in vivo studies
    • Learn how to incorporate rapid formulation technology screening into the overall early drug development strategy