Key Considerations For Cell Therapy Tech Transfer To Gmp Production

By Author: creative engg
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Despite the no-man’s land between academia and industry being a well-trod area, it is still fraught with pitfalls. This is especially the case when it comes to cell therapy tech transfer. While researchers are often frustrated with the overbearing rigor and control that forms the backbone of GMP, the industry too, is baffled by the seemingly laisse-faire approach in research. However, in order to translate research into meaningful therapies, industry and academia must be able to work harmoniously.
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With this in mind, and to assist with the cell therapy tech transfer ‘translation’, I’ve compiled a checklist of different areas to consider when performing tech transfer to GMP.

1. Define the Source Material

Issues in cell therapy tech transfer often arise as a result of the product development process starting outside of the industry for which it is intended, e.g. cell lines developed in academia passed to industry without any certificates of origin, or even ...
... cell lines that have not been fully characterised. This of course can lead to problems later down the track when Production are trying to make consistent batches for GMP validation purposes and wondering why the process isn’t working properly.

2. Define the Product

EMA/CAT/80183/2014 are the “go to” regulatory guidelines for cell therapy product design, BUT, the field is fast moving and the regulations are not always up to date. A good rule of thumb for cell therapy tech transfer is to design products for the international market – if it’s good for one, it’s likely going to be good for another (pending some minor tweaks).

3. Define the Manufacturing Process

Starting materials can be another source of frustration in cell therapy tech transfer as they are not always GMP quality. Cell lines may also be exposed to uncontrolled or non-human materials and consumables (e.g. mouse laminin for coating plates, vectors and viruses, BSA, cell lines). Ideally any manufacturing changes curing cell therapy tech transfer should be made as early as possible in the process to show that proceeding studies are still relevant (i.e. clinical data).

4. Define the Testing Requirements

Unlike other pharmaceuticals, biotech products often require very custom testing. There can also be unknown viral risks in new animals that require in-depth sequencing. Testing requirements must be defined as a part of the cell therapy tech transfer process.

To sum up:

To ensure as much success in the cell therapy tech transfer process as possible, ensure you:

define the quality of the source material

design out any foreseeable safety risks

select the most appropriate manufacturing platform for your process

check that your materials and consumables are GMP-friendly

check that your process is operator-friendly

identify the appropriate testing regimen for the product.

A big thing to note is that even if all the due diligence has been completed from initial research to GMP translation, the therapies themselves can change when they are in the patient environment.

Best thing to do is eliminate all the predictable sources of error in advance so you can address any additional surprises when they arise later down the track!

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Creative Engineering is turnkey pharmaceutical project consultants with inhouse engineering and fabrication expertise. As we have served more than 10 well-known pharma and chemical companies for engineering, fabrication and GMP-USFDA certification consultation, we are confident to serve you the best in the region. Our services include plant layout design as per GMP, project designing as per USFDA, MHRA, TGA, WHO, GMP etc. Creative Engineering - A Leader in Turnkey Engineering Project