Introducing ElevateBio’s Emerging Technology Lab
When ElevateBio was founded, we knew that the cell and gene therapy (CGT) landscape would need significant technological innovation to realize the true potential of these complex therapeutics – not only to design them and better understand what makes them safe and effective, but also to identify more robust and cost-effective ways to manufacture them at scale. Some of the required technologies were already available, but further improvements and developments were needed to enable process automation and aseptic processing. This meant we needed to think outside of the box to build the technological future of CGTs and truly bring about the sea change we envision for the field to change the future of medicine.
ElevateBio can think outside the box because we don’t focus on a single therapeutic modality and its associated technology. Rather, we span the entire spectrum of genetic medicine modalities and have visibility and access to a wide range of tools and technologies deployed across the biotech sector, as well as other sectors. We also have visibility to many of the common challenges and issues facing CGT development and manufacturing, which provides us with insights on the types of technological innovations that may be needed most. This broader perspective informs how we evaluate tools and technologies and apply them to the needs of CGTs.
To support our continued technology development efforts, we created our Emerging Technology Lab for cell and gene therapies. This lab was carved out with a focus on new technologies to yield high-quality, potent therapies, using more robust, cost-effective and scalable manufacturing approaches, so that more patients can benefit from genetic medicines.
What we do
Technological innovation is critical to the development and manufacturing of CGTs because they are far more complex than small molecules or biologics – and their complexity is only increasing as the development landscape evolves.
To stay ahead of these increasing product complexities, our emerging technology lab is a beta testing center for new devices, reagents, analytical technology, sensor technology, automated and digital control systems, with a focus on addressing common cell and gene therapy manufacturing challenges.
As a technology-driven company, we are constantly evaluating new tools on behalf of vendors, partners, and industry collaborators. Many of the technologies we evaluate were designed and built for just one, very specific purpose that applies to a single therapy or approach. But from our 30,000-ft viewpoint of the entire genetic medicine sector, we can look at existing tools and recognize how they could be used in new and different ways, such as redeploying the robotics used in factory warehouses for process automation. We present the technology to the whole team – with its breadth of experience – and ask: How could we use this piece of technology beyond what it was designed it to do?
Table 1 highlights several examples of our evaluations in terms of the novel or emerging technology type, the process unit where it would be used, and the advantages or improvements it could offer.
What makes our approach unique
ElevateBio is certainly not alone in evaluating emerging technologies for genetic medicines.
However, companies tend to focus on technology development according to what is relevant to the segment(s) of the product life cycle they occupy: a company developing therapies for first-in-human studies is probably not developing a commercial-ready automated and closed manufacturing process; CDMOs and other companies that specialize in GMP manufacturing run the risk of dedicating most of their time to establishing consistent and efficient operations and not investing enough time and effort in evaluating novel technologies for improving product design and process development. By contrast, ElevateBio occupies the entire product life cycle, and our expertise is unique because of the previous experience some of our team members have in developing some of the early CGTs that are now commercially approved, as well as our ongoing exposure to many different products and therapeutic modalities at all phases of development.
Therefore, ElevateBio’s focus is more technology-intensive than other companies because we occupy the entire continuum of genetic medicines development. Our end-to-end technological capabilities and expertise allow us to pursue technology development in ways that are unmatched by other companies in the sector. Our technology development efforts also have a positive impact across the whole sector because they benefit our partners and vendors as well as our internal programs.
Continuous technology development is critical to addressing the challenges of genetic medicines, now and in the future. ElevateBio keeps ahead on this curve, evaluating whether emerging technologies, inside and outside biotech, could fit into and advance our capabilities – and our team of super-smart thinkers bring a unique perspective to these evaluations. We hope our work to pioneer and push technology development for genetic medicines will lift the entire industry and ultimately serve more patients better.
Table 1. Examples of Novel and Emerging Technologies Evaluated by ElevateBio
| Technology Type | Process Unit Operation | Purpose of Technology |
|---|---|---|
| Bioreactor Platform | Cell Expansion & Harvest | Fully controlled, flexible, and automated smart cell processing platform with in-line analytics |
| Activation, Transduction & Expansion | Condition T cells through activation, transduction and/or expansion in incubator to increase their function in TME | |
| Cell Sorter Device | Cell Isolation | Alternative device for isolating rare blood cell populations at high purity to reduce operation time and complexity |
| Cell Processing Device | Starting Material Processing | Rapid, microfluidics-based closed-system process to separate PBMCs from apheresis or whole blood |
| Cell Processing Platform | Cell Wash & Concentrate, Cell Separation Harvest, Fill/Finish | Automated closed system for multiple unit operations to streamline manufacturing and reduce risk |
| Gene Modification Delivery System | Gene Modification | Closed and automated system for gentle, multiplex delivery of genetic material to cells |
| Lipid Nanoparticles (LNPs) | Genetic Material Delivery | Non-viral cell targeted formulation for delivery of genetic material |
| Non-DMSO Cryoprotectant Solution | Fill/Finish | Natural organic compounds to protect the integrity of cells during cryopreservation |
| DNA Template for HDR | Non-viral Genetic Modification | Alternative CRISPR templates for gene editing |
| Selection/Activation Reagents and cell selection kit | Cell Selection & Activation | Alternative reagents (including non-magnetic, nanobeads, etc.) to reduce cell process complexity and shorten vein-to-vein time, alternative kit and reagents to increase efficiency and effective phenotype and to reduce raw material manufacturing COGS |
| Bioreactor Harvest Device | Viral Vector Harvest Unit | Continuous manufacturing, improving harvesting yields |
| Bioreactor Perfusion Device | Viral Vector Production | Upstream process intensification, continuous manufacturing, improving harvesting yields |
| Chromatography Resins | Viral Vector Purification | Improve impurity removal during viral vector downstream processing |
| Purification Device | Nanofiber material for vector concentration and purification | |
| Purification Reagent | Chromatography-free tagging system for viral vector purification | |
| Nucleases | Viral Vector Nucleic Acid Digestion | Improve nucleic acid digestion during viral vector downstream processing |
As of September 2024
