Cell Therapy
Gene Therapy
Raw Materials

Ensuring a Robust Supply of Biomaterials to Meet a Growing Industry

30 December 2021
Dominic Clarke, CTO of Cell and Gene Therapies at Discovery Life Sciences discusses the importance of a diverse and reliable donor pool in the development of cell therapies, and considers the significance of this consistency when transitioning to GMP-compliant processes.

Dominic describes some of the trials, tribulations and opportunities associated with collecting biospecimens during a pandemic, as well as the importance of a coupled and collaborative approach to biospecimen collection and characterisation with supportive services.

Could you please introduce yourself and your role at Discovery Life Sciences?

I’m Dominic Clark, the Chief Technical Officer for Discovery Life Sciences. I work to help understand the needs of our clients within the cell and gene therapy industry, feeding back that information to our team and then facilitating solutions to develop the best possible products and services designed to enable the industry and our clients to develop critical life-saving therapeutics.

What are the challenges cell therapy developers face in the context of biomaterials availability and supply?

That’s a great question and one we could probably spend countless hours talking through – many in the industry are debating these various challenges.

First though, you have to pause and remember that we’re still a young industry. There are a limited number of approved therapies, but also a massive pipeline with many challenges associated with the processes that we’re developing to manufacture these therapies.

There’s a lack of standardisation, as many would say, but we have to be careful about trying to rush standardisation when we have so much diversity in these processes.

One thing sometimes forgotten with cell-based therapies is the fact that a significant portion of these therapies rely on access to human donors, whether it be for diseased or healthy tissue. Challenges that come with biomaterial supply then include consistency – having consistent access to these materials and the diversity that comes with that – quality, and the combined components of speed, flexibility and supply continuity to support the ever evolving needs of the therapeutic manufacturers, developers and the industry as a whole.

What are the benefits of a large donor pool and a consistent supply of both diseased and healthy biomaterials when transitioning to a GMP-compliant workflow?

We could explore a number of different directions here, but there’s such a variety of diseased and healthy biomaterials in demand, having broad access to a large donor pool is critical to supporting the development and the early discovery of some of these therapies.

Thinking about the downstream aspect from there as you move into, for example, process development for an autologous or an allogeneic therapy, you need a large donor pool to support the development of these processes. Having access to a large number of healthy donors with a high level of diversity allows for the development of these processes.

Having access to those ‘same donors’ or starting source material is also a benefit from a GMP compliance standpoint, as the starting source material from these donors can then be used in the manufacturing of the final therapeutic that’s going to go into the patients.

Having a variety of sites or access to recallable donors really aids that supply chain and some of the other industry-wide challenges previously covered.

How could a robust biomaterial supply affect the industrialisation and commercialisation process to impact the accessibility of cell therapies for patients?

Most of my efforts have been focused on process development of cell and gene therapies. Often, we have to shift gears and think about the process from early discovery through manufacturing. From that vantage point, it’s important to consider how early target discovery can ultimately lead to improved process development and manufacturing consistency, which will subsequently lead to greater clinical efficacies.

By having a more robust biomaterial supply as well as the services coupled with that biomaterial supply, we are able to support effective scaling to get these therapeutics to patients.

How is Discovery Life Sciences positioned to support the industrialisation and commercialisation journey for developers?

Single cell analysis coupled with our supporting services uniquely positions us to support cell and gene therapy developers from our ability to highly characterize disease tissues, identify novel biomarker targets or even analyze the efficacy of the final therapeutic. These all require a deeper type of interrogation.

On the disease biospecimen side, it’s our extensive access and all of our analytics capabilities; enables our partners, downstream, who are developing and discovering new therapeutic targets, which then can be coupled with our healthy starting materials for process development and therapeutic manufacturing.

For the cell-based starting materials, it’s not only about finding the right donor with a specific HLA type, for example, but we’re also able to characterize the cells that we’re obtaining from donors to better position our partners downstream to facilitate more consistent manufacturing processes leading to a more consistent final product.

I feel it’s important for the industry to really understand the combined capabilities and the products provided at DLS. It’s not just a biospecimen, it’s the access to highly characterized and annotated biospecimens and services that position us as the go to partner.

Biomaterials require donors, and with a lot of restrictions that we had with Covid-19, biomaterial collection has been a challenge. How was biomaterial supply – as well as your other services – affected by the pandemic?

Obviously the pandemic was a major challenge for all of us but at Discovery, we were able to stay open and functional, continuing to collect biospecimens from donors to support those who were still continuing their efforts.

We were able to quickly incorporate Covid-19 testing of our donors as soon as that was available.

We were also able to serve as an overflow lab for other facilities when they weren’t able to continue operations to help fill some of the gaps and solve some of the challenges for clients during the global pandemic.

Another important component is that we were able to stay open to immediately start collection of Covid-19 specimens to help advance related therapeutic and vaccine development efforts of BioNTech / Pfizer vaccine.

What do you think the cell and gene therapy industry will look like if the in the future?

If everything continues to grow and expand at the rate it’s going, following the approval of the autologous CAR-Ts today for example, I think we will continue to see more improvements with some of the manufacturing processes to make these processes more personalized and at the bedside.

Thinking about some other examples, I expect we’ll see tremendous growth with allogeneic therapies in the coming years. This will include new target discovery and novel receptors with some of it branching beyond haematological malignancies into solid tumours where there’s already been a lot of activity. So hopefully we’ll see success and continued clinical advancement.

We won’t discuss in detail here but let’s not lose sight of the development of iPSC’s and how they’re going to possibly shape the future of the industry!

I’ll continue my optimism and say that we’re going to see a number of novel, commercialized products and approvals both on the autologous and even on the allogeneic side, and we will have the ability to deliver these life-saving therapies to more and more patients globally.

How could a vast and diverse donor pool help this level of growth be sustainable?

Where we’ve been and what we’re seeing is that it’s really about big data, and now we’re hearing a lot about big data, analytics and AI. You can throw those terms around, but what does that really mean and how do we harness the vast potential?

In our efforts to further advance these therapies, it comes down to characterizing your product and then ensuring it’s effectively and consistently manufactured, and I think this comes back to having access to a large, diverse donor pool and biospecimen repository.

I think there’s an opportunity to then provide more deeply characterized starting cell-based materials combined with the supporting services specifically designed to truly meet the needs of the therapeutic modalities as we move forward.

At Discovery, we understand the importance of speed and flexibility and how that directly impacts therapeutic development. Our established highly characterized donor pool coupled with the capabilities and expertise in-house enable us to deliver rapid, reliable and scalable access to the donors and cell-based starting materials advanced therapy developers and manufacturers need for success.

So I feel it’s about enabling smarter selection for faster timelines at scale to advance therapeutic and manufacturing efforts, coupling those capabilities that we already deliver today, and working with our partners to ensure we have better materials to work with, together with better tools to develop better, more effective therapies.

Is there anything that we should be looking out for from Discovery Life Sciences?

As I’ve learned quickly, Discovery does not sit idle! We want to educate on some of the topics that we’ve already talked about – on the importance of characterizing, smarter characterisation of donors and how that’s going to advance therapies more efficiently.

Ultimately, this industry flourishes through partnership, it’s a collaboration – we have to work smarter and work together. We can continue to build an extensive biospecimen bank and network of highly characterized donors based on what we believe is best, but this ideally stems from working closely with our clients and the industry to understand what’s coming; how we can use analytics to characterize and deliver access to the evolving and expanding biospecimen products and services needed. I think you’re going to see a lot from Discovery.

Moving forward, we have big plans to not only grow our local donor base and then characterize that more extensively, but also expand collection sites globally, so hopefully that will start to show itself in the coming months and over the next year. We also recently expanded our capabilities in vitro. We purchased a company called In Vitro ADMET which is enabling us to focus on biospecimens, hepatocytes and toxicities and where they can be utilized for diagnostic development, cell and gene therapy discovery and toxicology assessments.

Again, there are a number of exciting announcements you’re going to see from Discovery.  We are going to be really active in this space.

One of the places we will be seeing you in-person is Miami at Advanced Therapies Week 2022. Is there anything we should be expecting from you in Miami?

We’ve got a number of things highlighted at the event, which we’re really excited about being a part of! I, myself will be chairing a session on Thursday, January 27th at 11:00am entitled, ‘Development in Allogeneic Cellular Therapies’, so that should be an excellent topic for discussion with some great speakers.

I want to also highlight on Tuesday the pre-workshop as part of the ISCT Commercialisation Signature events series, hosted in conjunction with Phacilitate, so I’m really excited about having that co-located event and support.

Finally, you can find us at booth 507. We’ll be there set up and ready to greet all our partners and industry colleagues.

I’m looking forward to a great event and being out there in-person, really seeing the advancements of the field.

Click here to discover more about joining us at Advanced Therapies Week 2022.

This feature was developed in partnership with Discovery Life Sciences.