Cellares

The science behind cell therapy is proven, the next frontier is building the infrastructure to deliver it at scale. Join a forward-looking discussion hosted by DeciBio on: • How manufacturing models — centralized, decentralized, or point-of-care — can expand patient access • How regulators and payers can adapt to new technologies without slowing access • The role of automation in manufacturing and QC to enable affordability and global consistency 🎙️ Speakers: 🔹 Christopher McDonald, former Head of Tech Ops, Kite 🔹 Nelly Viseux, VP of TechOps, Regeneron 🔹 Christian Capitini, Director of Carbone Cancer Center, UW–Madison 🔹 Fabian Gerlinghaus, CEO & Co-Founder, Cellares 🗓️ Monday, October 20, 2025 🕐 2:00 - 3:00 PM PT 🔗 Register here: https://lnkd.in/gd32qU4J #CellTherapy #CGT #Automation #Innovation #Biomanufacturing #Webinar

What an incredible week at the 2025 Cell & Gene Meeting on the Mesa! A huge THANK YOU to Alliance for Regenerative Medicine for bringing together the #CGT community and sparking conversations to improve patient access. During his plenary talk, Cellares CEO & Co-Founder Fabian Gerlinghaus introduced the Biotech Incentive Program, designed to help early-stage developers stretch capital further, de-risk the path to clinic, and turn funding into milestones faster. As the industry works to balance quality, speed, and cost, Cellares is proud to partner with innovators at every stage of development to achieve all three and make commercial-scale manufacturing a reality. Reach out to BD@Cellares.com to explore how we can extend your runway and accelerate your journey to the clinic. #CGMesa25 #CellTherapy #Innovation #IDMO #CellShuttle #CellQ

Looking forward to an insightful discussion with DeciBio and industry leaders Christopher McDonald, Nelly Viseux, and Christian Capitini, on how manufacturing, automation, and access are shaping the future of cell therapy. 🗓️ Monday, October 20, 2025 🕐 2:00 - 3:00 PM PT 🔗 Register here: https://lnkd.in/gd32qU4J #CellTherapy #CGT #Automation #Innovation #Biomanufacturing #Webinar

We’re proud to see the Cell Shuttle named to TIME’s Best New Inventions of 2025 list! For Cellares, this isn’t just recognition of a technology. It’s acknowledgment of a problem worth solving: too many patients still die waiting for curative cell therapies that science has already made possible. From CAR T cells that fight cancer to regulatory T cells that restore immune balance, cell therapies are redefining what’s possible in medicine. What limits their reach is not biology but manufacturing. Each therapy is still made by hand for a single patient, slowing access and driving up cost. The Cell Shuttle changes that by automating end-to-end manufacturing and enabling 16 cell therapy doses to be produced in parallel on a single system. As the first technology to receive the FDA’s Advanced Manufacturing Technology (AMT) designation, the Cell Shuttle is being deployed across the U.S., Europe, and Japan to support expedited regulatory approval and global commercial-scale production. With The Nobel Prize honoring discoveries in regulatory T cells and immune tolerance this week, it’s clear that the next frontier for cell therapy is not scientific possibility – it’s scalable delivery. We’re deeply proud of our team, grateful to TIME for this recognition, and more motivated than ever to make cell therapy manufacturing scalable, reliable, and within reach for every patient who needs it. See the full list here: https://lnkd.in/dSEqKGfm #TIMEBestInventions #CellTherapy #CGT #Automation #Innovation #Treg #CART

Cell and gene therapies now offer curative outcomes for once-incurable diseases. Yet the systems built to manufacture them haven’t kept pace. Most biologics facilities were never designed for its complexity, variability, and patient-specific nature. Now, as the FDA and Congress move to restrict the offshoring of clinical materials, the United States faces a defining question: can we build the infrastructure to produce these therapies domestically, securely, and affordably? The FDA’s Advanced Manufacturing Technologies (AMT) program marks a turning point. The first AMT designation in cell therapy was granted to Cellares' Cell Shuttle, a fully closed, automated platform that streamlines end-to-end manufacturing and accelerates regulatory timelines. Paired with our Cell Q automated QC platform, this ecosystem embodies the FDA’s quality-by-design vision and reduces manual intervention, strengthens data integrity, and accelerates patient access. What’s at stake is more than efficiency. It’s the creation of a resilient, standardized, patient-ready CGT manufacturing infrastructure. Meeting this challenge isn’t just a technical imperative, it’s a moral obligation to ensure every patient who can benefit from a cell or gene therapy receives it in time. Read more in this month’s cover story in Drug Development & Delivery. #CellTherapy #CGT #Innovation #Automation #CellShuttle #CellQ

Congratulations to Cellares CEO and Co-Founder Fabian Gerlinghaus for being named to BioSpace’s 40 Under 40! An aerospace engineer by training, Fabian has channeled his purpose and technical rigor into solving one of biotechnology’s most urgent challenges: ensuring that patients whose lives could be saved by FDA-approved cell therapies don’t die waiting due to manufacturing and QC bottlenecks. With over a decade of experience as an inventor and leader, Fabian has a track record of assembling top-performing teams to drive novel bioprocessing technologies from ideation to commercial readiness. Since co-founding Cellares with Omar Kurdi in 2019, Fabian has led the company through remarkable growth and global expansion. Under his leadership, Cellares has raised more than $355 million, partnered with major pharmaceutical leaders such as Bristol Myers Squibb, hired over 280 employees, and established operations across the U.S., Europe, and Asia. See the full list of winners here: https://lnkd.in/eB_Xe-eS #CellTherapy #CARTCR #CART #Innovation

Cellares’ CEO & Co-Founder, Fabian Gerlinghaus, will speak at the 2025 Cell & Gene Meeting on the Mesa on Monday, October 6th at 5:15 PM. His talk, “Turning Capital Into Clinical Milestones: Extending Runway with the World’s First IDMO”, will explain how the Biotech Incentive Program helps early-stage developers stretch capital, de-risk development, and accelerate regulatory timelines. We look forward to sharing more and connecting in Phoenix, Arizona! #CellTherapy #CARTCR #CART #Automation #CellShuttle #CellQ #cgmesa25

"Science moves fast. Manufacturing must move faster." That was Cellares’ message at the 10th Annual CAR-TCR Summit Series last week. 🔹 We demonstrated end-to-end manufacturing of Non-Hodgkin’s lymphoma patient material on the Cell Shuttle™, and revealed fully-automated QC release data from the Cell Q™, purpose-built to meet the demands of commercial-scale quality control. 🔹 Cabaletta Bio confirmed “Cell Shuttle data is within our clinical historical range” and announced plans to treat the first patient with the Cell Shuttle in H1 2026. 🔹 We launched the Biotech Incentive Program to help early-stage developers stretch capital, de-risk development, and accelerate regulatory timelines. Find us at 2025 Cell & Gene Meeting on the Mesa (table M3) to learn more! 🔹 Patient voices brought urgency. Laurie Adami, the first patient treated with Yescarta for follicular lymphoma at UCLA, and Adam Clark of the Emily Whitehead Foundation urged us all to ensure manufacturing never limits patient access. Together, we supported the Foundation’s 5K run and Believe Bundles initiatives. Thank you to everyone who joined us in Boston, including Benjamin McLeod for bringing attention to the promise of cell therapy. The summit reinforced what drives us: bringing scalable, reliable, and accessible cell therapy to more patients. Looking forward to connecting again at 2025 Cell & Gene Meeting on the Mesa! #CellTherapy #CARTCR #Automation #CellShuttle #CellQ #IDMO #Manufacturing #QC #Cellares #cgmesa25

The 2025 Cell & Gene Meeting on the Mesa is just one week away, and we can’t wait to share exciting updates with you! 🔹 Schedule a one-on-one meeting via PartneringOne or at BD@Cellares.com 🔹 Visit booth #M3 to learn about our IDMO services and the new patient performance data generated on the Cellares Cell Shuttle and Cell Q platform 🔹 Join our presentation on “Turning Capital Into Clinical Milestones: Extending Runway with the World’s First IDMO” on Monday, October 6, at 5:15 PM, featuring Fabian Gerlinghaus, CEO & Co-Founder of Cellares We look forward to connecting and sharing the IDMO journey with you! See you in Phoenix! #cgmesa25 #CellTherapy #CART #Innovation #CellShuttle #CellQ #Cellares