Organizing Digital Systems Around Novel Modalities
By Jason Bock, Ph.D., CEO, and Duane Avant, CTO, CTMC
In the modern era of personalized medicine, autologous cell therapies that harness a patient’s own cells are generating significant interest and investment for their ability to tackle hard-to-treat diseases. Advanced immunotherapy techniques that genetically enhance the patient’s cells to better recognize and kill cancerous cells improve the efficacy and tolerability of these treatments, but novel manufacturing approaches are needed to deliver individualized therapies in a timely and consistent manner. Manufacturing autologous cell therapies requires close coordination with clinical staff, as well as processes that scale out rather than scale up. To meet this demand, manufacturers and developers should, when and where feasible, engage early with manufacturers of digital systems to map out processes, identify and address operational bottlenecks, and ensure patients receive high-quality cell therapies in a timely manner.
Creating Connections For Enhanced Digital Integration
Digital systems can perform many important functions. MRPs and ERPs are materials and enterprise resource planning systems that are helpful for managing needs and understanding costs. Manufacturing execution systems (MES) can electronically track batch records, laboratory information management systems (LIMS) organize workflows and data, and other systems act as quality management tools. But managing and organizing these digital systems around novel modalities such as cell therapies is an intricate process.
One challenge is that many digital systems are designed for batch manufacturing of traditional therapies, whereas autologous cell therapies require individualized production. Furthermore, cell therapies demand specialized instrumentation that often are not compatible with existing digital systems. To pair digital systems with new instrumentation requires collaborating and coordinating with system and equipment companies that may be hesitant to allow modifications to their intellectual property. Life sciences companies dedicated to the advancement of cell therapies must build strong relationships with these parties to facilitate the collaboration and adaptations necessary for digital integration.
Ideally, engagement with digital systems and equipment manufacturers should begin early in development to minimize the need for future costly retrofits, custom integrations, and process redesigns. Early collaboration can help establish a more cohesive, scalable digital infrastructure capable of supporting a therapy from development through commercialization. However, for many early-stage biotech companies operating with limited capital and resources, building these relationships and managing complex integration efforts independently may not be practical. In these cases, partnering with organizations that have already established connections with digital systems providers and equipment manufacturers can significantly reduce risk, accelerate implementation, and allow innovators to focus their resources on advancing the therapy itself.
Once these digital tools have been appropriately customized, drug development and manufacturing companies must ensure that the information captured by these digital systems is not siloed. The long-term goal is to integrate all of these systems, connecting management, billing, LIMS, and more under one overarching entity. This type of centralized system could be further enhanced with AI to help manage manufacturing availability and timelines. A fully integrated digital network also results in a more efficient experience for cell therapy developers, facilitating increased transparency for monitoring their projects. Patients will similarly benefit as connected digital networks improve turnaround times, enabling timely access to these cutting-edge therapies.
By coordinating this digital transformation, drug development and manufacturing partners can provide the infrastructure and industry connections needed to build on the early success of cell therapies. The goal should be to connect established digital systems with new instrumentation and consolidate the wealth of information generated into a central hub, thereby helping developers automate their cell therapy production.
Getting Smart About Scaling Out
Beyond the software challenges, the science of process automation can be a significant hurdle. Often, the production processes that are developed in early stages are “fit for purpose,” and while suitable for proof-of-concept studies, their highly manual nature rapidly multiplies cost and labor demands as production scales. Rather than rushing to automate these early processes, therapeutic developers should recognize the start of clinical trials as an important pivot point.
A one-to-one automation of a highly manual process is rarely feasible, and even when achievable, the resulting process is likely to be highly ineffective. One example is the manipulation of critical starting material such as fragmented tumors for TIL therapy. This relies on a skilled operator who understands the precise method of dissection based on the characteristics of the tumor and cannot be replicated through automation alone. Instead, successful digital integration requires rethinking and redesigning processes to align with automated technologies and existing digital infrastructure. Modifying the complex procedures that generate cell therapies requires deep knowledge of critical process parameters, key quality attributes, and stringent regulatory guidelines. Experienced development and manufacturing partners can help navigate this complexity by applying their process expertise to identify what elements of manufacturing can be altered and at which clinical stages those changes should be introduced.
As production scales out, companies will need to transition from single-site trials into multisite studies. Historically, this has been a significant bottleneck for cell therapy sponsors. Autologous cell therapies require close coordination between manufacturers and clinical sites. Patients may need to stop certain medications or wait for test results to clear them prior to donating cells. Additionally, some patients may need to be prioritized due to the critical changes in disease progression. Aligning patient timelines with manufacturing availability is challenging when managing a single location; expansion into multiple sites can quickly make these logistics overwhelming.
In discovery and early-stage development, one of the most important considerations is determining whether a therapy can be reliably supported by the realities of the supply chain as it advances into clinical testing. Feasibility depends on several factors, including whether source materials and final products are fresh or cryopreserved; the stability and shelf life of critical materials; and the number of collection, manufacturing, testing, and treatment sites involved. As programs expand beyond a single institution, coordination becomes increasingly complex.
Digital systems can provide valuable visibility into these processes by helping teams track materials, monitor chain of custody and chain of identity, evaluate logistical constraints, and identify potential bottlenecks early in development. When combined with AI, these systems can model different scenarios to identify conflicts and risks. By assessing supply chain feasibility alongside scientific and manufacturing considerations, developers can design processes that are not only effective in the laboratory but also scalable and practical for multicenter clinical trials and eventual commercialization.
Continued Momentum With Digitization
Cell therapies represent an important advancement in our ability to treat difficult cancers, but the continued exploration of this new modality will require new digital tools and equipment. Partnering with the right resources and expertise throughout this process empowers developers and manufacturers to customize and integrate digital systems. The right partner can also help cell therapy developers prepare their processes for digitization and create transparency. With the right approach, digital systems can help ensure that new cell therapies are accessible to clinics and patients around the world.
About The Authors
Jason Bock, Ph.D., is a biotech leader with a track record of translating cutting-edge science into impactful biologic therapies. As CEO of CTMC, a joint venture between MD Anderson Cancer Center and Resilience, he leads efforts to bridge academic discoveries with industrial drug development and advanced manufacturing, accelerating transformative cell therapies to patients. Since its 2022 launch, CTMC has guided eleven novel cell therapies through IND clearance. Previously, Bock spent a decade at Teva Pharmaceuticals, where he grew the biologics team to 600+ employees, advanced 15 novel drugs, and led three to global commercialization. He holds a BS in biology from MIT and a Ph.D. in molecular and cellular physiology from Stanford University.
Duane Avant, chief technical officer at CTMC, has more than 25 years of biopharmaceutical industry experience. He has led quality, regulatory, technical operations, and manufacturing organizations across cell and gene therapies, biologics, vaccines, nucleic acids, and drug products. Prior to joining CTMC, Avant served in executive leadership roles at Resilience, including chief regulatory and quality compliance officer and chief quality officer, and previously held senior leadership positions at Lonza and Eli Lilly. A Lean Six Sigma Black Belt and chemical engineer by training, Avant has extensive expertise in product commercialization, regulatory approvals, quality systems, operational excellence, and scaling advanced therapies from development through commercial manufacturing. He holds a Bachelor of Science in chemical engineering from the University of South Carolina.