What a new clinical trial means to production

The cell and gene therapy (CGT) field continue to evolve, introducing innovative approaches that may translate to clinical trials.

The personnel of cell therapy production facilities are used to manufacturing cells for clinical trials, and they usually make adjustments to accommodate new trials. Lately, the pace of introducing new clinical trials has picked up both in quality and quantity. In this post we will discuss the potential changes that come with new clinical trials, and the reasons why production personnel should pay attention to these changes.

• Contact Person(s)

Every clinical trial has it’s own team of clinicians, co-ordinators, and probably curriers. Production personnel need to clearly identify the contact person to (i) maintain an effective communication, and to (ii) ensure protected health information are communicated only to those who are authorized to receive them.

• Protocol

If not entirely new, often, new clinical trial is a repetition of a previous one, but with slight changes to improve the overall outcomes. Some might assume that a clinical trial with the same sponsor means the protocols are identical. This assumption may end up with a production deviation, a deviation that can easily be avoided with proper attention.

• Material

With production material, not only the name of material should be identified, but also the specifications. Besides, even when a material of the same specifications is used, the preparation method might be different, which may change the final concentration.

• Training

Production personnel should be trained on working on the new protocol and using the documents and material specific to that protocol. Such training needs to be successfully completed documented for each team member before allowing this member to participate in production.

• Release Testing

New products have their own production protocol which defines the required testing, and the acceptable results. Further, timing for sampling vary by protocol and need to be verified. All pre-process, in-process, and release testing need to be scheduled throughout the production cycle.

• Packaging

Production personnel need to be trained on dispensing the final product in the final containers and at the right volume and concentration. These aspects are critical for patient treatment, unapproved changes may result in a product that no longer suits the patient.

Production personnel are capable to switch from one production protocol to the other; they don’t rely on their memory, instead, they use production documents that were carefully designed to account for all parameters.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us. 

About the author

Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here