The demand for cell therapy product testing is increasing rapidly, as more researchers begin the process of transitioning their therapies into the commercialisation pipeline. As noted in a recent interview with Phacilitate, the Alliance for Regenerative Medicine reported that between 2015 and 2020 the number of regenerative medicine companies grew from 672 to 1001 and the number of clinical trials from 631 to 1078. All this growth means that there will continue to be a critical need for testing services to ensure safety, efficacy and performance of advanced therapies.
The availability of this type of specialised testing has not kept pace with the demand, so what we have repeatedly seen is that a GMP experienced laboratory focused on early and effective collaboration, plus smooth technology transfer, are critical success factors in helping researchers and therapeutic developers move their therapy toward clinical trials and, hopefully, commercial launch.
The challenge for many therapeutic developers has been the identification and selection of a laboratory for testing and manufacturing support. For this discussion, we are focusing on the laboratory selection process, providing a roadmap to help developers as they navigate the process. Finding the right laboratory can be complicated. To do an RFP, or to not do an RFP, that is the question…
This roadmap is designed to help narrow your search as you begin having conversations with the sales and support teams from the available laboratories. Creating an RFP (request for proposal) or RFI (request for information) can help you refine your needs and requirements and providing this information can also help the laboratory start with a better picture of your needs. Use the roadmap and your requirements document (RFP or RFI) to help identify the best laboratory to help you get your product to market or to help you maintain your product on the market.
Here is a brief roadmap to help researchers and companies that are moving into clinical trials, or even those who have a product in clinical trials, identify a laboratory testing partner that offers customisable solutions and provides a superior testing experience:
- Select a GMP experienced lab
- Choose your laboratory partner early
- Assess technology transfer capability and capacity
- Ask for examples of collaborative experience
- Intellectual property support
- Smaller may be better
1. Select a GMP experienced lab
Many testing providers have extensive lab testing experience, especially in the research setting. The key capability to investigate is how much experience a laboratory has with managing and testing samples that will be used for further manufacturing into advanced therapies, especially if the rare source material is human-based. Having access to GMP testing is a must-have to make the jump from investigation to commercial launch. Obtaining the required global accreditations takes time and considerable effort, which many organisations are not willing or able to do.
2. Choose your laboratory partner early
Even during your research phase, it will be helpful, and in some cases critical, to identify a laboratory partner early in the process. Collaboration with your identified laboratory partner earlier in the development cycle can help to prepare your therapy for making the jump from research to clinical trials and hopefully following successful trials, to commercialisation.
3. Assess technology transfer capability and capacity
These are critical assessments for the transfer of the test methods that will be required to ‘verify’ your therapy has the right potency and therapeutic material in the product intended for trial use. The FDA has highlighted the impact of critical quality attributes (CQAs). Therapeutic developers need to understand their target indication and identify or develop a clear set of potency assays or functional assays early on to support their regulatory approval.
4. Ask for examples of collaboration experience
Collaboration is communication on steroids, so take the time it takes to assess how well a laboratory embraces collaboration vs telling you how they will ‘perform’ your testing. When we were awarded an MTEC contract in 2016, our focus was on building a strong collaboration between the four companies involved in the contract award and supporting the start-up of our new biomanufacturing facility. A direct benefit of that project was the addition of cellular therapy testing to QualTex’s list of capabilities. We bring the MTEC experience along with years of custom assay development and GMP testing for donated human materials to every customer interaction.
5. Intellectual property support
While different situations may call for different approaches, ‘what is yours is yours, and what ours is ours and what we develop together belongs to both’ is often the best approach we have found in dealing with IP. Most laboratories understand this, but it doesn’t hurt to do your due diligence. As there are no established standards for potency, it is essential that researchers define their own standards that may require multiple assays using different platforms. Potency testing is likely to involve new tests or new combinations of testing, so IP management will be very important. There are also going to be different assays for different time points through the development process. We recommend that you start with functional assays – characterisation and possibly potency – in animal models and then look at other assays at different times for safety, potency and/or characterisation.
6. Smaller may be better
Smaller laboratories are more likely to offer ‘boutique’ support for clinical developers and collaborate more effectively to arrive at an optimal solution to support your therapy development. But don’t forget about the first five things to consider as you evaluate your choices for a laboratory testing provider. As a testing partner, we offer both research-grade and GxP assays. Biotech companies will need both options, based on where they are in the process of developing and commercialising their product – from qualification to quality control and release testing.
Chief Operating Officer