How our cell and gene testing services can support you

As new Advanced Therapy Medicinal Products (ATMPs) continue to provide innovative treatments to patients we are proud to support their development through our range of analytical, training and consultancy services.


Here RSSL Biological Sciences Lead Dale Hirst gives a brief step by step guide into the key areas that make up our comprehensive cell and gene testing offering. We see split our key capabilities in these six areas:


- Raw materials testing

- Biosafety testing

- Product characterisation

- Stability testing & storage

- Regulatory training & support


Find out how we supported an established client in our latest Cell & Gene Therapy case study

Video transcript

RSSL have been on campus in Reading for over 30 years now, which puts us really close to the golden triangle for cell and gene, which is you know Oxford, Cambridge and London where all the research is coming out and being developed. As we've expanded over time, you know, we've added labs organically and added to the teams, you know, just in response to our customers' needs.


In terms of our offering for cell and gene, it starts with everything from raw materials going into production, that could be simple buffer sorts, you know, complex mixture. Specifically, you know, we've expanded into the biological raw material - so this is all the growth factors and cytokines required to keep the cells happy. After that, we would look at the biosafety, so are the products sterile because they have to be sterile to go into the the manufacturing facility, obviously they have to be sterile except for the cell components to go back into the patient. So we offer various levels of biosafety - it could be bio burden, it could be endotoxin and it could be sterility testing, based on the needs of the customer.


When it comes to product specific characterisation, that really again, is based on customers needs so it could be simple IDs and this could be straightforward - it could be something like mass spec, could be an ELISA if it's a biological, but it could be a chemical test as well, so that's why it's needed. For stability, we offer as our customer needs, so we could be performing in use studies, which is how long once they're in the bags (you know, ready to go) for the the cell events, for the transformations for cell and gene therapy, are all the constituents stable for or we could go for how long are they stable long term.


Alongside the laboratory testing, we also offer quality training - so everything around the quality needs, whether that's QP training, whether that's GMP. We have specific modules for ATMPs and cell and gene, as well, so really we're looking after the product, around the product, and then the quality systems of our partners, you know, so every aspect of quality around the site as well.


All of our services are at one site or several interconnected buildings on the same site, so this means that when it comes to troubleshooting, you've not just got a team of five who would say 'this is ELISA problem, let's view the issue as an ELISA issue', it could be actually, it could be, a mass spec issue, it could be an impurity and we can bring that expertise all together very rapidly without having to go to cross-site, cross-country, you know, cross-nation collaboration. Responsive. Customer focused. Innovative. Friendly. Knowledgeable. Flexible. So, when you bring all these various aspects of RSSL together it really is all about science with service.

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