“We really do hope that by going through the risk based development strategies for cell therapies, there will be some information here that will be very helpful for any participants who might be looking at or who are in the process of developing a cell therapy...”
A recent panel discussion aimed to summarise and address some of those key considerations, featuring insights from Ward Carter (COO at QualTex Laboratories), Scott Jones (Vice-President of Scientific Affairs at BioBridge Global) and Emmanuel Casasola (Executive Director, Global Quality & Compliance at BioBridge Global.
Having moderated my first webinar with Phacilitate, I wanted to take a moment to reflect on some of my top takeaways from the presentation and Q&A session, focussed on 3 top tips for therapeutic developers in this area, as recommended by the panellists.
Tip 1 - Consider your testing services partnerThe importance of choosing the right collaboration partner was the first point stressed by Emmanuel Casasola. Often, therapeutic developers consider manufacturing, regulatory and clinical trial support, but the importance of selecting a good testing services partner can be overlooked.
A strong testing services partner, Emmanuel explained, will really look into what testing is necessary for clinical trials and in proving efficacy, so early partnering with a strong testing services provider is the first step to mitigating risks later in the development process.
Emmanuel continued to discuss common risks therapeutic developers may face, most notably highlighting:
- Selecting a lab that does not understand the assay lifecycle
- Appropriately estimating or understanding the lead time and lab capacity and the impact to the development timeline
- Not considering all geographies targeted for commercial development of the therapy
You might also be interested in:
- [WHITE PAPER] Testing Strategies and Custom Assay Development for Cell and Cell-Based Therapies
- [Q&A] Testing Strategies and Custom Assay Development for Cell and Cell-Based Therapies with Ward Carter
- [BLOG] Custom Assay Development for Safety, Purity and Potency of Cell Therapies with Scott Jones
- [BLOG] Developing Risk-Based Testing Strategies for Advanced Therapies with Emmanuel Casasola
Tip 2 - “Our mantra is potency, potency, potency…”A key theme stressed throughout the webinar was the level of consideration owed to potency.
Initially, Emmanuel explained how the onus is on the therapeutic developer to completely understand the differences in standards and requirements for potency assays, but added that once the expectations are fully understood, a good partner will be able to help qualify what the right assay is and how it works.
Essentially, the determination of potency using specific assays is essential to transition cell and cell-based therapy products to the final regulatory authorisation stages, Scott Jones explained while addressing the importance of potency assays.
“It’s not a good idea to assume that ‘you know’, especially when it comes to potency assays, so you want to make sure you understand those completely.”
While pre-existing assays may be used for some testing, some level of custom assay development is usually required, especially in determining potency, and therefore custom routes may have to considered in this area.
After demonstrating examples of potency assay results in the context of characterisation of MSCs, Scott further elaborated on the differences between qualitative (limit of detection) vs quantitative (limit of quantitation) assays, commenting on the importance of choosing the most sensitive assay available when assessing the safety of a therapeutic.
Tip 3 - Plan aheadUltimately, Ward Carter stressed, a key step to success is to plan ahead, and this came up a few times when addressing questions in the Q&A session.
Choosing the right lab is fundamental to the success of a therapeutic development programme, along with a robust development process. Defining specifications early will save you time (and money) in the long run, so again, planning ahead is key!
Finally, I would like to close by thanking Ward Carter, Emmanuel Casasola and Scott Jones for a comprehensive presentation and insightful panel discussion.
For this post, I have barely scratched the surface with the topics and depth covered in the session, but you can now watch the full discussion on demand.
Discover QualTex Laboratories with BioBridge Global: https://biobridgeglobal.org/products-and-services/testing-services/