Partner Case Study: Accelerating CAR T-Cell Therapy Manufacturing for Autoimmune Disease

In 2023, Kyverna Therapeutics and ElevateBio formed a partnership with a bold mission: to be the first to deliver cutting-edge CAR T-cell therapies to patients with autoimmune diseases. Today, that collaboration is yielding tangible results. Kyverna initiated a rolling Biologics License Application (BLA) submission for miv-cel (mivocabtagene autoleucel, KYV-101) for stiff person syndrome (SPS) in May 2026 - the first BLA submission for a CAR T-cell therapy for an autoimmune disease. This case study explores how Kyverna is leveraging ElevateBio’s process development and manufacturing capabilities to advance miv-cel towards commercialization.

The Challenge: Rapid Manufacturing Without Compromise

When Kyverna initially partnered with ElevateBio, the company needed to quickly execute a technology transfer of its autologous CAR T-cell therapy (miv-cel). But this was more than a handover of equipment. It started with documentation and required navigating compressed timelines, with a need to complete comparability quickly.

Any delay had the potential to impact clinical trials, patients, and regulatory process – which is why Kyverna needed a partner with the speed, flexibility, and commercial mindset to deliver a true blueprint for accelerated execution without sacrificing quality.

An Advanced Therapy CDMO Built for Acceleration

Unlike a traditional CDMO solely focused on transactional production services, ElevateBio helps biopharmaceutical companies design, develop, and manufacture therapies faster and more efficiently. With integrated discovery, process, and manufacturing capabilities, ElevateBio is redefining how advanced therapies are developed and scaled, acting as a true partner in innovation. Through its partnership, Kyverna received immediate access to ElevateBio’s end-to-end capabilities, expert teams in process development, analytical development, and manufacturing. Around the table, the two teams collaborated closely to advance towards a common mission of bringing potential life-transformative therapies to patients.

ElevateBio Accelerated Tech Transfer Without Compromising GMP Quality

The average industry technology transfer can take 12-18 months. When Kyverna began working with ElevateBio, they needed to move even faster to support an active IND filing while building a scalable foundation for future clinical and commercial development.

ElevateBio was able to complete the first comparability runs in the GMP environment within 4 months. Project kickoff to GMP readiness runs to support regulatory milestones and site qualification. Notably, the speed and rigor of this early collaboration established the operational and quality framework that helped support Kyverna’s advancement toward its recent BLA submission.

Key achievements included:

• Developed and optimized new GMP-ready batch records, manufacturing documentation, and fill instructions to support rapid clinical manufacturing readiness and long-term scalability
• Executed a successful comparability campaign with consistent right-first-time execution, minimizing runs, reducing risk, and keeping timelines intact
• Leveraged in-house analytical and quality systems tightly connected to manufacturing – enabling faster coordination, rapid data turnaround, and streamlined execution without reliance on third-party testing
• Evaluated and qualified analytical assays and microbiological safety methods ahead of comparability runs, helping ensure robust data generation and proactive risk mitigation
• Completed all comparability successfully supporting accelerated data delivery for critical regulatory timelines and avoided delays to clinical development

Accelerating a full technology transfer while maintaining rigorous GMP and quality standards is a highly complex achievement – one that reflects the agility, cross-functional coordination, and technical expertise of the teams involved. The rapid transfer established a strong operational and regulatory foundation that helped support the continued advancement of miv-cel toward commercialization.

A Partnership Built for Scalability  

As Kyverna advanced miv-cel through clinical development and toward its rolling BLA submission, ElevateBio served as a strategic manufacturing partner supporting the program’s evolving operational and regulatory needs. Together, the teams advanced Kyverna’s miv-cel platform, helping support the speed, coordination, and quality execution required for a complex cell therapy program.

Key elements of the partnership included:

• ElevateBio’s manufacturing capability enabled the speed, coordination, and continuity required for a complex, patient-specific cell therapy program, ensuring seamless execution across regions and timelines
• ElevateBio’s commercial-ready infrastructure and quality systems provided confidence that manufacturing will scale alongside the program’s advancement. ElevateBio’s ICMC ™ certification for cell and gene therapy manufacturing further reinforced GMP excellence and future readiness
• A flexible, highly collaborative operating model allowed both teams to rapidly adapt to evolving program needs, maintaining speed without compromising quality or execution standards

Together, the partnership demonstrates how integrated manufacturing expertise, operational flexibility, and aligned execution can help accelerate complex cell therapy programs from early development through regulatory milestones and toward commercialization readiness.

Building the Foundation for Regulatory Success

By combining accelerated technology transfer, integrated manufacturing execution, and close cross-functional collaboration, Kyverna and ElevateBio established a strong operational foundation that helped rapidly advance miv-cel through pivotal clinical development and key regulatory milestones, including BLA submission for SPS.

What began as an accelerated technology transfer evolved into a strong partnership spanning process development, GMP manufacturing, analytical support, and clinical supply execution. Across this continuum, the collaboration demonstrated that speed and rigor are not competing priorities, but rather mutually reinforcing priorities when enabled by integrated capabilities and aligned execution.

This enabled Kyverna to progress the first CAR T-cell therapy in autoimmune disease through a key regulatory milestone. Importantly, every milestone was guided by a single objective: delivering a transformative therapy to patients living with autoimmune disease.

In July 2026, ElevateBio announced a commercial manufacturing and supply agreement with Kyverna for both U.S. commercial and global clinical supply of miv-cel, extending our multi-year partnership.