Cell therapy weekly: Treg therapy collaboration
This week: Nucleus Biologics (CA, USA) launched a bioreactor-scale, pod-based media and buffer manufacturing system, Kincell Bio (FL, USA) and RegCell (CA, USA) announced a collaboration to advanced regulatory T cell (Treg) therapies, and Gemini Bioproducts released a media optimization service that utilizes AI, machine learning and multi-omics data.
The news highlights:
- Pod-based media and buffer manufacturing
- Treg therapy collaboration
- AI-driven media optimization for cell therapy
Pod-based media and buffer manufacturing
Nucleus Biologics has launched Krakatoa® K500, the first bioreactor-scale system for on-demand production of sterile media and buffers at the point of use. By integrating preformulated powder pods, a closed single-use workflow and fully automated operations the system aims to simplify bioproduction processes, reduce costs, and eliminate reliance on centralized media preparation, cold-chain transport and complex supply chains.
“Krakatoa is regarded as the loudest sound heard on earth. We believe this product can shift the cost model and create a new paradigm for how bioprocessing liquids are delivered to the bioreactor,” said David Sheehan, Founder, President, and CEO of Nucleus Biologics. “This product is the result of 6 years of development, and I am proud of what our team has created. We listened to our customers’ frustrations with the complex process of centralized GMP liquid media manufacturing. With the Krakatoa® K500, we begin a journey to co-locate both media and buffer bioproduction and ultimately intelligence-based improvement of bioprocessing liquids to achieve better yields. As an industry, we must question established norms and lean-out and cost-reduce processes if we want to increase patient access.”
Treg therapy collaboration
Kincell Bio, a US-based cell therapy contract development and manufacturing organization (CDMO), has partnered with RegCell, a biotechnology company focused on developing an immune tolerance platform using epigenetically reprogrammed regulatory T cells (Tregs). Under the agreement, Kincell will support RegCell’s lead Treg program by providing CMC development, process and analytical transfer, scalable manufacturing process optimization, and GMP clinical material supply to facilitate IND-enabling activities and clinical trials.
RegCell’s platform converts CD4+ T cells into stable, antigen-matched Tregs by replicating key epigenetic features involved in Treg stability. The platform does not rely on gene editing or viral DNA reagents, which reduces manufacturing complexity and allows for potential automation and point-of-care applications.
“I’m excited for Kincell Bio to support RegCell as they advance a deeply innovative therapeutic approach rooted in decades of foundational immunology,” said Bruce Thompson, President and Chief Technology Officer of Kincell Bio. “RegCell’s science represents a significant advancement in the treatment of autoimmune disorders, and our team is committed to providing the technical solutions and GMP execution required for clinical success.”
AI-driven media optimization for cell therapy
Gemini Bioproducts has announced the launch of aiMOS™ (Artificial Intelligence Media Optimization Service), a first-of-its-kind service developed in collaboration with Tolemy Bio which utilizes AI, machine learning and multi-omics data to create custom media supplements for cell therapy manufacturing. It is designed to enhance critical quality attributes (CQAs), optimize manufacturing efficiency, and reduce costs for T-cell, NK-cell, TCR, and TIL therapies.
“By applying causal AI modelling to a cell’s metabolic and behavioral fingerprints, our platform can identify the exact levers that drive cell therapy performance, potency and yield. With that information, we can then predict the ideal supplement composition and concentrations to specifically enhance cell performance,” said Alex Ward, cofounder, Tolemy Bio. “Paired with GeminiBio’s cGMP manufacturing and custom filling capabilities, aiMOS gives cell therapy developers a practical, high-impact way to achieve better performance—with full confidence to scale from early development through commercialization.”