COLD CHAIN
Cryoport to deliver Gradalis autologus immuno-oncology therapies across US
Gradalis’ Vigil Engineered Autologus Tumor Cell (EATC) therapy is currently in Phase II/III trials for high risk stage III/IV ovarian cancer and Phase IIb for Ewing’s sarcoma – an ultra-rare type of bone cancer in children and young people.
Vigil EATCs are designed to activate patient T-cells against the cancer whilst also reducing the tumor’s ability to suppress the patient immune system.
Cryoport will provide the necessary expertise and tech needed to maintain a cGMP compliant supply chain, to deliver the cell therapy platform to each clinical centre.
Sunil Joshi, CEO of Gradalis, said "We rely on Cryoport's advanced cryogenic logistics solutions to maintain the integrity of our clinical trial work as the therapies are transported between Gradalis' manufacturing and various clinical sites.
He added “We are at a critical stage of our development and we need to ensure proper access for our clinical trial participants. Cryoport, as with all of our partners, will play a critical supporting role in the success of our clinical programs.”
Autologus cell therapy
The Vigil Engineered Autologus Tumor Cell (EATC) platform works by taking a patient biopsy of the cancerous tissue to harvest a compliment of patient specific antigens ex vivo. Gene editing is also used to modify and reduce the immune suppression action of the tumor.
This stage requires refrigerated transport of the patient biopsy to Gradalis manufacturing site in Carrolton, Texas.
Once prepared, the personalised suspension of Vigil EATCs is diluted into vials which are frozen for shipping to the hospital of clinical site a few days before the patient administered is the therapy via intradermal injection.
Vigil EATCs are also being trialled in pilot combination studies with PD1/PDL1 checkpoint inhibitors for non small cell lung cancer, melanoma and triple negative breast cancer patients.
Cold chain network
Mark Sawicki, COO of Cryoport, has previously told Outsourcing-Pharma that autologous therapies provide a particular challenge.
This is due to the complexity of their supply chains, which require high tech biostorage units and a system for monitoring environmental controls 24/7.
Services such as the firm’s Cryoport Express liquid nitrogen dry vapour dewars, the Cryoportal logistics management and SmartPak monitoring systems are used to maintain the integrity of materials as they are moved between hospitals, manufacturing, storage locations and the point of care.
Sawicki also told us: “As clinical trials move to remote areas, time and infrastructure can be even more challenging,” and “we are always working against the clock.”
