Just in Time Release of CAR T Cell Therapies

11th November 2019 | 10.00 am EST | Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux |WATCH FOR FREE

The views and opinions expressed during the Webinar are those of the presenter.

Currently CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. As such manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release.
Risk based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented eliminate the risk or to reduce the risk to an acceptable risk level.
Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This Webinar will highlight microbial contamination control and testing strategies that can be employed throughout each stage of the manufacturing process that will allow for a potential just in time release of CAR T products.

Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene

Irving Ford is currently the Head of CAR T QC Laboratories at Celgene. Prior to joining Celgene, Irving was a significant contributor for activities supporting the commercial approval of Novartis’ CAR T product Kymriah®. Irving has over 28 years of QA/QC experience in the pharmaceutical/biotechnology and cell and gene therapies industries including, but not limited to, non-sterile, sterile, and low bioburden manufacturing production. Irving has designed, implemented and managed paperless laboratories. Irving has a successful track record working with laboratory, facilities, validation, manufacturing, regulatory, QA, R&D, and compliance personnel to manage and resolve complex quality and manufacturing issues. Irving has served as the subject matter expert during numerous contract service provider audits as well as for regulatory inspections/filings. Irving was also involved in the successful consent decree remediation at McNeil Consumer. Irving is an active member of PDA and has served on the several planning committee’s for various PDA Conferences. Irving is also a co-author/contributor for the PDA’s TR for EM of Low Bioburden Facilities. Currently, Irving is working on a task force for creating an ISO Standard for apheresis collection. Irving is also co-authoring a White Paper for appropriate microbiological controls for ATMPs manufacturing.

And Lori Daane, Pharma Microbiology Scientific Director at bioMérieux

Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology.  She is a technical expert on Rapid and Alternative Methods and participates in the sourcing and evaluation of new technologies and potential partnerships in the field of microbial control.  She provides scientific support to the Healthcare Business in North America and is responsible for managing feasibility testing and method development for bioMérieux instruments and culture media products.  Lori received her Ph.D. from the University of Minnesota in Microbial Ecology.  She also holds a Master’s degree in Limnology from the U of MN and a Bachelor’s degree in Medical Technology from Ferris State University.

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