The center, Cell Processing and Cryopreservation (CPC) Services, has been specifically developed to provide decentralized clinical trial support, including timely sample processing and data capture that are essential to accurately gauge the outcomes of clinical trials.
Currently, contract research organizations (CROs) are able to support this increased level of vaccine trials by obtaining clinical trial subject’s blood at specified time points.
However, there is still a lack of organizations with the capacity to support the full range of trial sponsor needs in collecting and processing participant samples.
This includes sample processing to isolate cells of interest and cryopreservation capabilities, a critical intermediate manufacturing step.
Cell isolation and cryopreservation often needs to be completed within the critical timeframe from collection, typically four to six hours. If this is not achieved, the risk of data and trial outcomes being affected by undesirable phenotypic and functional changes is considerably increased.
There is also a growing requirement for rapid cryopreservation of apheresis material for the continually growing number of autologous cell and gene therapy (CGT) trials.
Many hospitals, cancer centers, clinical sites, and other translational centers included in CGT product administration and patient apheresis currently lack cryopreservation capabilities, and pharmaceutical and CGT companies have limited resources to support these efforts in house.
In addition, the transport of patient apheresis material to a central processing lab for cryopreservation and subsequent transport back, poses significant logistical challenges and risk of loss of patient material.
As a result of this demand, OrganaBio has launched its CPC Services division to offer decentralized cell processing and cryopreservation services across the US.
For the last 18 months, the company has run an early access program to deliver these services to select multi-national big pharma partners.
The division will initially focus on the US market but may expand when there is increased international market demand.
Justin Irizarry, CEO of OrganaBio, said: “OrganaBio continually seeks to expand its CTDMO capabilities to support the development of therapies by providing solutions where they are required across the sector. OrganaBio’s product and services portfolio now serves a therapy’s entire development lifecycle.
“The continued demand for, and growth of, vaccine and CGT trials has led to areas where the market’s ability to support these trials has fallen behind. This risks delays to the delivery of vital therapies to patients. This is why OrganaBio has and will continue to invest considerably in the launch of CPC Services to provide decentralized clinical trial support initially across the US, following the success of its early access program to select large pharma partners. OrganaBio hopes, as a result, to provide vital decentralized support to vaccine and CGT trials across the US and affect materially the delivery of a range of therapies to patients internationally.”