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Article by AABB - "A Natural Fit: Blood centers are ideally suited to expand operations into cellular therapy product processing”

 

Cellular therapy products for use in the clinic, especially those for use in clinical trials, are increasingly manufactured using cGMP regulations in clean room facilities. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMPs ensure proper design, monitoring, and control of manufacturing processes and facilities. While there are many other considerations to think about when choosing the right cGMP partner, the design of the facility to control operations, careful consideration of the type of products, the stage of manufacturing, the flow and the HVAC requirements are excellent places to start assessment. 

 

Expert cGMPs can establish quality management systems, maintain and validate equipment & operating procedures, keep adequate documentation and records, and thoroughly train personnel

 

 

Facilities- In deciding where processing should occur, the organization must consider the risk of contamination to the product during manufacturing. Greater risk requires a more restricted environment. Facilities for working under cGMP conditions can take many forms in which there can be aseptic processing:

 

Products-Consider the type of product to be manufactured:

 

Scale of manufacturing-Consider the scale of manufacturing. Is the facility licensed for commercial production or limited to early-stage clinical trial products? While cGMPs are expected throughout clinical studies, the level of control and validation will vary depending on the process and likely to increase as products move from one phase to the next.

 

Flow-Consider the flow.  The flow of material and personnel is designed to control the manufacturing environment. The flow:

 

HVAC System-Consider the HVAC system. What is the risk of contamination?

Creating a cGMP facility from an existing laboratory, or from scratch can be an expensive, time consuming endeavor. Instead, choosing the right cGMP partner does not have to be. CCS is one of the few organizations that can provide in-depth service, expertise and support for your cGMP needs via in-house manufacturing or consultation and we take careful consideration of the current and potential needs for your organization and for the industry.

 

For more on the role Comprehensive Cell Solutions plays in the cell therapy space, download and read the May 2019 edition of AABB News here.