Addressing the challenges of preserving cell and gene therapies

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

Sponsor

Addressing the challenges of preserving cell and gene therapies

Delivery of cell therapies often requires the ability to hold products in readiness whilst logistical, regulatory and potency considerations are dealt with and recorded. This often requires cryopreservation of the product which itself poses many biological and biophysical challenges to living cells that need to be understood in order to apply the low temperature technologies to their best advantage. Join this webinar to hear about the latest advances in cryopreservation, and the challenges for robust and reliable uses of cryopreservation within the cell therapy arena.

Our panel of experts – Dawn Maier, Unum Therapeutics, Alaina Schlinker, Fresenius Kabi – will be speaking with our Guest Moderator, Dr Qasim Rafiq, UCL, to discuss their real-world experience in tackling these critical preservation challenges including:

Processes and related impact of freezing at known cell concentrations.
The need for closed-system automated fill/finish methods for pre-clinical and clinical applications.
Latest advances in cryopreservation technology to support the scalable supply requirements as the cell and gene therapy sector continues to grow.

Throughout the webinar, you will have the opportunity to pose your questions to our expert speakers.

Webinar attendance is free of charge, but places are limited, so register today to guarantee your participation. If you’re not sure if you’re free on the day, please register anyway and we will send you the link to the recorded webinar as soon as it is live.

Qasim Rafiq

Associate Professor of Cell & Gene Therapy Bioprocess Engineering at University College London

Associate professor at UCL’s Advanced Centre for Biochemical Engineering, Qasim’s research focus is on addressing translational challenges of robust manufacture of stem cells that are needed to take regenerative medicines into the clinic. This includes the “whole bioprocess” from sourcing of raw materials and cells, through cell expansion in bioreactors and ultimately the downstream processing needed to purify and concentrate cell product for delivery to the patient. He previously lectured in Bioprocess Engineering at Aston University, where he was Principal Investigator on 4 grants with funding from RCUK, EU Horizon 2020, InnovateUK and commercial sources. Qasim completed his PhD at Loughborough.

Alaina Schlinker

Senior Manager, Cell Therapy Application Support at Fresenius Kabi

Alaina Schlinker has provided application support for the LOVO Cell Processing System since its commercial launch in June 2014. Alaina and her team work with customers to optimize the LOVO Cell Processing System to meet specific applications throughout the cell therapy manufacturing workflow. Alaina’s team alsoworks closely with the Fresenius Kabi R&D group, collaborating to bring customer feedback and Fresenius Kabi’s core competencies together in the development of new technology.

Alaina has degrees in chemical engineering (BS from University of Southern California and PhD from Northwestern University). Her thesis research focused on in vitro platelet production from CD34+ stem and progenitor cells as alternative source of platelets for patients.

Dawn Maier

Senior Director, Process & Analytical Development at Unum Therapeutics

Dawn has been working in the field of cell and gene therapy for ~ 15 years. She obtained her Masters in Biology in 2002 from Western Carolina University. From 2002 to 2006 she worked in an academic research lab, studying gene therapy and HIV. In 2007, Dawn took a position as a validation scientist at the Clinical Cell and Vaccine Production Facility (CVPF) at University of Pennsylvania. She spent 6 years at UPenn in a number of roles doing not only pre-clinical translational studies but also development of GMP manufacturing processes for numerous autologous cellular and gene therapies in early phase clinical trials. In addition, Dawn was also involved with managing QC/QA operations, preparing for FACT accreditation and contributed to writing IND CMC sections and also a Drug Master File for K562 derived aAPC. Her current position at bluebird bio is as Associate Director of Cellular Process Development and Manufacturing, where she leads the group in the development, optimization and technology transfer of clinical manufacturing processes for cell and gene therapy products. Since joining bluebird, she has participated in the development, translation and tech transfer of the following programs: Lenti-D for adrenoleukodystrophy, Lenti-G for beta-thalassemia and sickle cell disease, and anti-BCMA CAR-T for multiple myeloma.