APR 08, 2021 1:00 PM EDT

Cryopreservation and Logistics of Advanced Therapy Medicinal Products: A Cold Subject Suddenly Becomes a Hot Topic

Speaker

Abstract

Advanced therapy medicinal products (ATMPs) are ‘living drugs’ that have proven highly effective at treating diseases, such as cancer, that were once thought untreatable. As ‘living drugs’, ATMPs require complex chemistry, manufacturing, and controls (CMC) to enable efficient commercialization and maintain therapeutic consistency and potency. Part of these controls is the need to implement optimizing freezing protocols to facilitate the long-term frozen storage and transport of ATMPs from the manufacturing site to the clinic. Cryopreservation for ATMPs requires specialized storage conditions and distribution channels to maintain ATMPs at ultralow temperatures (e.g. below -80°C) that permit proper biological function post-thaw. As evidenced by the recent COVID vaccine approvals, cryogenic storage and distribution at ultralow temperatures is a challenge for the existing pharmaceutical infrastructure and a hinderance to the widespread distribution of ATMPs. Solutions to overcome the challenges of cell cryopreservation, storage, and distribution at ultralow temperatures need to be identified, validated, and implemented to increase ATMP adoption for the general population. This presentation will introduce the audience to the challenges associated with ATMP cryopreservation, as well as provide potential solutions for how these challenges can be tackled during ATMP development, from pre-clinical through commercialization.


Show Resources
You May Also Like
SEP 17, 2021 12:00 PM CST
C.E. CREDITS
SEP 17, 2021 12:00 PM CST
Date: September 16, 2021 Time: 9:00pm (PDT), 12:00am (EDT) 3D cellular models like organoids and spheroids offer an opportunity to better understand complex biology in a physiologically rele...
SEP 14, 2021 7:00 AM PDT
C.E. CREDITS
SEP 14, 2021 7:00 AM PDT
Date: September 14, 2021 Time: 7am PDT, 10am EDT, 4pm CEST A conventional thermal cycler has long been a commodity product in the lab and end-point PCR techniques can be completed almost wit...
DEC 01, 2021 7:00 AM PST
C.E. CREDITS
DEC 01, 2021 7:00 AM PST
Date: December 01, 2021 Time: 7:00am (PST), 10:00am (EST) In the era of immuno-oncology, there is a growing need for the identification of new biomarkers predictive for sensitivity to anti-P...
SEP 16, 2021 8:00 AM PDT
C.E. CREDITS
SEP 16, 2021 8:00 AM PDT
Date: September 16, 2021 Time: 8:00am (PDT), 11:00am (EDT) Rapid screening and speed of scale-up in protein therapeutics are critical factors in today’s biotech and pharma workflows. T...
DEC 07, 2021 10:00 AM PST
C.E. CREDITS
DEC 07, 2021 10:00 AM PST
Date: December 07, 2021 Time: 10:00am (PST) The RNAscope™ technology allows high sensitivity and spatial resolution providing pivotal single-cell information to gain better insights in...
JUN 24, 2021 8:00 AM PDT
C.E. CREDITS
JUN 24, 2021 8:00 AM PDT
Date: June 24, 2021 Time: 8:00am (PDT), 11:00am (EDT) Cardiovascular disease is a leading health problem, affecting almost 30% of individuals in the developed world, and comprises a wide ran...
Loading Comments...
Show Resources