Clinical Support and Kitting (CSK) Drug Development Solutions for Support of Cell & Gene Therapies

The age of cell and gene therapies (CGTs) is upon us! It has been a long road to get to this time. The first gene therapy trial on humans was performed in 1990 by researchers at the National Institutes of Health. The first FDA approved CGT came in 2017. One major challenge that still stifles the CTG field is sample logistics, specifically the integrity of samples for support of drug development.

 

Pharmacodynamic/Biomarker assays are often performed on live cells, whole blood or Peripheral Blood Mononuclear Cells (PBMCs). Live cell assays are critical to support of CGTs are for demonstrating efficacy/mechanism of action (MoA) and are required for most submissions due to a lack of a true pharmacokinetic measurement. Transportation of live cells require specific collection by the clinic and proper shipment. It can be as simple as standard process of collecting a K2EDTA whole blood sample and shipping at room temperature overnight, to as complex has collecting, isolating, harvesting, counting, and freezing PBMCs and putting them into liquid nitrogen. All sites can do the former, but the later requires expertise and special equipment which most clinical sites do not have.

 

At KCAS, we offer clinical supplies and kitting that provide solutions to sample logistic challenges for support of CGTs. We routinely perform method feasibility studies using specialty tubes and stabilizers to ensure your PD/Biomarker assay functions properly and meets the intended use of the method. With the addition of the FlowMetric team and our expanded Capabilities (qPCR, ddPCR & ELISpot) our experience and knowledge for support of CGTs is helping to pave the road to unleashing the power of CGTs.

 

We have been supporting drug development at KCAS for over 42 years and our CSK team has been instrumental in our pointing bionalalytical method. We continue with the evolving needs of our clients. During COVID times our Clinical Supporting and Kitting team has only highlighted the need for exceptional planning to support drug development for CGTs. I often tell our clients that there is not much we can do to redevelop or revalidate a method if the samples were not collected and stored properly for a live cell assay. It breaks my heart every time I’m told a story where this is the case.

 

We want to be the solution to problems that others can’t fix when it comes to CGTs.

 

Our CSK team – in conjunction with our operations team – can provide customized kitting supplies and seamlessly perform feasibility studies using a wide range of specialty tubes (CPT, Cyto-Chex BCT®, PAXgene®, SMART), write the collection manual, and help train clinical staff to ensure your CGT data is reliable and defendable. We are confident that our CSK team can provide an optimal client experience supporting full clinical programs or one-off specialist studies. If you’d like to hear more about our CSK capabilities, please contact KCAS.