Cellares

The FDA’s Advanced Manufacturing Technology (AMT) designation is reshaping how cell therapy developers approach manufacturing changes. For years, sponsors were told that switching platforms after entering the clinic was too risky, too slow, and too difficult to navigate with regulators. The consequence? Many reached pivotal trials or even approval with processes that couldn’t scale commercially. That paradigm is shifting. AMT provides a structured, evidence-led framework to upgrade manufacturing without derailing clinical progress. Key shifts highlighted in the recent BioSpace piece are: 🔹 Derisked mid-trial transitions: Rather than “all-or-nothing,” AMT supports staged transitions onto the Cell Shuttle platform—keeping trials on schedule. 🔹 Parallel comparability strategy: Run side-by-side lots with pre-agreed readouts while dosing continues, preserving clinical continuity. 🔹 Earlier, prioritized FDA engagement: More touchpoints to align on acceptance criteria, controls, and data expectations before making clinical material. 🔹 Built-in scalability: Avoid arriving at commercialization with processes that are too costly or inefficient to sustain. As Anna Rolda McMahon McMahon, Director of Regulatory Affairs at Cellares, noted: AMT “fundamentally changes the risk equation” for developers by providing clearer, faster, and more predictable pathways to adopt industrialized manufacturing solutions offered by the Cellares IDMO Smart Factory. Want to leverage AMT to upgrade your process before it’s too late? Reach out: BD@Cellares.com Read the in depth BioSpace coverage on this topic here: https://lnkd.in/gR8MH3Nj #CellTherapy #CGT #Commercialization #AdvancedManufacturing

Great insights from Nelly Viseux’s presentation “Keeping the Cell Therapy Development Momentum from Early to Late-Stage Clinical Manufacturing” at Advanced Therapies Congress in Philadelphia. Her presentation underscored the importance of building manufacturing strategies that stay robust from early development through late-stage clinical work, where automation, standardization, and technology-enabled platforms can unlock real clinical acceleration. We’re encouraged by her team’s continued exploration of Cellares’ integrated manufacturing technology and the potential introduction of our platform into clinical trials. Partners like Regeneron are making the strategic decisions today that will position them to meet the total patient demand that comes with successful commercialization. #celltherapy #CGT #automation #innovation #ATUSA2025

We’re thrilled to welcome Ali Soleymannezhad as Cellares’ new Chief Commercial Officer! Ali brings 20+ years of commercial leadership across bioprocessing and biomanufacturing, and he joins us at a pivotal moment for the industry. With demand for automated, global-scale cell therapy manufacturing accelerating, his leadership will be instrumental as we expand our IDMO Smart Factory network across the U.S., Europe, and Japan. A special thank you to Alex Cooke, Founder & CEO of Phase 3 Search, for helping us find a leader so deeply aligned with our long-term vision. Read the full press release here: https://lnkd.in/gCV6SEAw #CellTherapy #CGT #Biomanufacturing #IDMO

Powerful perspective from PMWC. The next leap in precision medicine require industrialized infrastructure. Excited to see the Cellares Cell Shuttle and Cell Q highlighted as examples of how automated, integrated platforms are reshaping what’s now possible in CGT manufacturing.

Cellares recently met with FDA’s CBER Advanced Technologies Team (CATT) to discuss how Cell Q, our end-to-end QC automation platform, can modernize quality control for commercial cell therapy manufacturing. Why this matters? QC is the hidden bottleneck of cell therapy. Traditional analytics rely on multiple benchtop instruments, manual sample prep, fragmented data streams, and lengthy release timelines. These challenges intensify as developers move from early clinical work to global commercial supply. Cell Q changes that paradigm by integrating best-in-class instruments, automating assay execution, and generating fully digital, compliant data packages that connect directly to electronic batch records. What we aligned with FDA during CATT engagement:  🔹 Qualification strategies for automated assays, instruments, and software 🔹 Data integrity expectations across electronic records and audit trails 🔹 Regulatory pathways for using Cell Q to support Sponsors’ IND/BLA filings Strategic impact for developers adopting advanced analytics: 🔹 Greater regulatory confidence through structured FDA dialogue 🔹 Data-driven decision-making via real-time QC insights 🔹 Faster QC release and shorter vein-to-vein timelines Our CATT meeting reflects a shared commitment to establishing regulatory standards that will benefit the entire industry. By engaging early and transparently, Cellares is helping to shape and standardize regulatory pathways for advanced analytics technologies. What analytics challenges are limiting your commercial scale-up? Let’s discuss how integrated QC automation can de-risk your clinical path and accelerate patient access. Contact us at https://lnkd.in/gywuTdtd #RegulatoryExcellence #FDA #Manufacturing #QualityControl #CGT #CellTherapy

The future of cell and gene therapy depends on smart infrastructure and even smarter regulations. Cellares' CEO Fabian Gerlinghaus joined the Fierce Life Sciences Events panel, “Cell & Gene’s Future with the New FDA: What’s Unfolding & What’s Ahead,” to discuss how regulatory innovation, global competitiveness, and manufacturing scalability will shape the next chapter of #CGT. Key themes that can accelerate clinical milestones and expand patient access included: 🔹 Building U.S. manufacturing resilience — Programs like the FDA’s Pre-Check initiative have the potential to speed facility readiness and strengthen domestic capacity. 🔹 Consistent, constructive agency engagement — Even amid leadership transitions, the FDA’s Office of Therapeutic Products remains stable, collaborative, and focused on enabling progress. 🔹 Meaningful impact from the FDA’s Advanced Manufacturing Technology (AMT) designation — Cellares Cell Shuttle's AMT designation provides partners with priority regulatory review and accelerated clinical milestones. A big thank you to Fierce and our outstanding panelists for a thoughtful, forward-looking discussion. 📺 Watch the full recording: https://lnkd.in/gsA_FNGM #CellTherapy #Innovation #Regulatory #FDA

Quality control may sit downstream of manufacturing, but it often determines whether the cure is released or whether a patient keeps waiting. In a new special report from Drug Target Review, Cellares CEO Fabian Gerlinghaus explains why QC has become the invisible bottleneck in cell therapy and how automation can finally remove it. Today, a single patient dose can generate hundreds of handwritten records across dozens of assays and instruments. This complexity drives up costs, increases failure rates, and leaves some eligible patients untreated. Cell Q changes this. Built on a digital quality backbone, it automates end-to-end assay execution and connects performance directly to electronic batch records, delivering compliant, reliable data at commercial throughput. 📄 Read the special report + Fabian’s profile (Page 8): https://lnkd.in/dYCvafgK #CellTherapy #Automation #QualityControl #CellShuttle #CellQ #Manufacturing #CGT

What an energizing week at the Advanced Therapies Congress USA in Philadelphia. Cabaletta Bio’s sessions underscored just how much momentum is building behind next-generation manufacturing and how close the field is to achieving truly scalable, reliable, and patient-centric solutions. Houman Dehghani shared the latest advances in manufacturing technology, noting: “All of our engineering runs on the Cell Shuttle were successful and fall within our historical ranges.” Strong comparability data from split donor runs further reinforced the platform’s performance as Cellares moves toward first patient dosing in H1'26. Sarah Yuan emphasized the importance of operational agility in a fast-evolving field, stating: “Being agile has helped our company in a positive way, including pivoting to a new phase-appropriate manufacturing platform with Cellares.” Yan Li also shared key insights on streamlining process development to ensure programs can scale efficiently without compromising quality. A promising future lies ahead for the cell and gene therapy community, and we’re proud to partner with innovators like Cabaletta who keep patients at the center as they push the boundaries of scientific innovation. #ATUSA2025 #Biotech #Innovation #Automation #CellTherapy #CGT

What a fantastic evening at the PDA West Coast Chapter (PDA WCC) Quality Ball, and a powerful reminder when quality leads the way, we design systems that are more connected, reliable, and ultimately better for patients. During the panel discussion, Eric Fulmer, VP of Quality at Cellares, highlighted how this philosophy underpins everything we build: from fully automated manufacturing on the Cell Shuttle to end-to-end QC automation on Cell Q, each platform is engineered so quality and innovation move in lockstep. We’re leaving the Quality Ball energized and inspired to continue building the future of smart, compliant, patient-focused manufacturing. #celltherapy #CGT  #industrialization #quality #innovation

The regulatory landscape is shifting and understanding what the new FDA direction means for CGT commercialization is more critical than ever. Looking forward to Fabian Gerlinghaus’ session, “Cell and Gene's Future With the New FDA: What’s Unfolding and What’s Ahead,” alongside experts from BMS, Epicrispr, Alliance for Regenerative Medicine and Fierce Pharma. #CellTherapy #CGT #Biomanufacturing #Innovation #IDMO