Modality Solutions Focuses on Supply Chain Validation and Cell Therapy Clinical Trials at SBE Conference

Modality Solutions Focuses on Supply Chain Validation and Cell Therapy Clinical Trials at SBE Conference

Modality Solutions presented at the Society of Biological Engineers (SBE), part of AICHE (American Institute of Chemical Engineers) virtual “3^rd Cell Therapies and Immunotherapy Conference.” The conference focused on gene and cell therapies and other immunotherapies. It included cutting edge developments on gene therapy manufacture, microenvironment engineering of tumors, and the use of CAR-NK therapies led by the Houston-based MD Anderson Cancer Network.

Rob Battista, a Senior Engineer with Modality Solutions, focused on supply chain validation for CAR-T cell therapies. While Modality Solutions Principal, Dan Littlefield, focused on best practices to apply to cell therapy clinical trials in developing countries.

Rob has extensive experience in distribution validation for biologics and gene therapies. He shared his gene therapy expertise with the conference by focusing on risk assessment and transport simulation. According to Rob, supply chain hazards have the potential to affect patient safety and therapy efficacy via:

• Damage to the quality of the therapy
• Supply chain errors causing delayed or missed dosing of patients
• Quality violations during shipment
• And the loss of patient-specific material

For transport simulation, Rob advocated concurrent exposure of therapies to applicable parameters at the edges of the supply chain’s multi-dimensional operating space (e.g., temperature, pressure, shock, vibration). After exposure to realistic and concurrent simulation, the commonly analyzed quality parameters include cell count, cell viability, post-thaw proliferation, and phenotype purity assays.

Dan is a thought leader and recognized expert in cold chain engineering support for emergency response clinical trials, including work with NIH, CDC, BARDA, and WHO. He focused on the practical aspects of the challenges associated with clinical trial logistics in developing countries, such as the importance of risk assessment, equipment qualification, and the use of roleplaying scenarios in emergency response training.

Dan outlined as part of the risk assessment the importance of evaluating existing controls for hazard prevention impacting product storage. In his example, he explained that a set of controls with a common failure mode are not independent layers of protection. Modality Solutions considers these important details every time they conduct a risk assessment and have successfully conducted more than 100 risk assessments for many clients’ logistics processes under many circumstances.

The use of emergency response scenarios as part of training is an excellent example of how the breadth of Modality Solutions’ team experience applies to every aspect of their work product. Dan’s experience in defense and law enforcement, along with his work as a hazmat technical expert with DuPont, allow him to develop topical and engaging scenarios where staff roleplay the incident from initial investigation, troubleshooting, response, and mitigation. President Gary Hutchinson noted that he uses a comparable scenario-based training to assist clients in preparing for regulatory reviews.

Regarding the conference itself, Rob said, “I want to thank the SBE for the opportunity to present alongside all the other esteemed researchers. I found the work on centrifugal reactors used for mAbs adapted for cell therapies to be especially interesting.” Dan shared he also appreciated the opportunity, and noted, “I think Rob and I are a bit downstream for this audience, but we always encourage everyone in the discovery chain to consider how to get the therapy to the patient, since it’ll matter eventually.”