ElevateBio BaseCamp Achieves ICMC™ Certification for Commercial Cell and Gene Therapy Manufacturing Capabilities

• ICMC certification delivered by Dark Horse Consulting certifies ElevateBio’s compliant and scalable manufacturing capabilities for advanced therapies using U.S. and E.U. commercial-level evaluation standards
• BaseCamp is the first genetic medicine manufacturing business to receive certification across viral gene delivery, non-viral gene delivery, and cell therapy products

Waltham, MA, August 13, 2025 – ElevateBio, a technology-driven company focused on powering the creation of life-transforming genetic medicines, today announced it has received comprehensive certification from the Initiative for Certification of Manufacturing Capabilities (ICMC™) program for its viral gene delivery, non-viral gene delivery, and cell therapy manufacturing capabilities at its flagship ElevateBio BaseCamp facility in Waltham, Massachusetts.

The ICMC certification, administered by Dark Horse Consulting (DHC), is designed to address the industry's most critical manufacturing challenges through assessment of capabilities to help reduce regulatory risk, accelerate development timelines, and increase probability of technical success. Through the certification process, DHC evaluates nine comprehensive systems, expanding upon the seven systems outlined in FDA's CBER Compliance Program Guidance Manual Chapter 45 for Biological Drug Products and incorporating EU Directive 2003/94/EC standards. Meeting the criteria of ICMC’s comprehensive evaluation systems is a demonstration of ElevateBio's commitment to quality, compliance, and manufacturing excellence.

“This comprehensive ICMC certification represents the most rigorous third-party manufacturing evaluation available in our industry today," said Michael Paglia, Chief Technology Officer at ElevateBio BaseCamp. “The nine-system framework proactively confirms our commercial manufacturing readiness across capabilities that satisfy and expand upon standard regulatory requirements. This certification across cell therapy, viral vector, and mRNA modalities underscores our unique capability to support a diverse range of advanced genetic medicine technologies and demonstrates our readiness to seamlessly scale manufacturing from clinical through commercial stages, enabling our partners to accelerate their path to market without manufacturing disruptions.”

ICMC Certification Criteria: Nine Systems for Commercial Manufacturing Readiness

The ICMC certification program provides independent, third-party verification of manufacturing capabilities in the cell and gene therapy contract development and manufacturing organization (CDMO) market to enable therapeutic developers to make informed manufacturing partner selections. Through this certification, the BaseCamp Waltham process development and cGMP manufacturing facility has demonstrated proficiency across nine critical systems:

• Service Business System: Ensures reliable partnership and project management and seamless knowledge/technology transfer into a GMP environment, including a review of the Person in Plant framework and business continuity response plans, critical for therapeutic developers navigating complex manufacturing partnerships
• Quality System: Provides rigorous quality system framework that reduces approval risks, ensures compliance, and accelerates time-to-market for advanced therapies
• Digital System: Delivers data integrity and cybersecurity, essential for protecting intellectual property and meeting stringent regulatory data handling requirements
• Facilities and Equipment System: Ensures controlled manufacturing environments specifically designed for advanced therapies. Demonstrates cross contamination control
• Materials System: Enables reliable supply chain management of inventory, from procurement through testing, release, and storage: critical for therapies dependent on precisely-specified starting materials
• Production System: Ensures consistent, reproducible manufacturing processes essential for therapeutic efficacy and safety across clinical and commercial scales. Verifies that products can be produced aseptically.
• Packaging and Labeling System: Maintains product identity and chain of custody throughout the manufacturing process.
• Laboratory Control System: Provides reliable testing and verification methods critical for quality release decisions and regulatory submissions, from initial transfer through qualification and validation
• Commercial Readiness: Establishes manufacturing scale-up capabilities and process validation protocols required for successful transition from clinical to commercial production

The independent certification process employed regulatory-grade methodologies over several weeks, including multiple days of on-site verification and interviews, covering hundreds of documents. Importantly, these global quality systems in place set a strong foundation for commercial readiness at ElevateBio’s BaseCamp Pittsburgh facility, which is under construction at Hazelwood Green and is expected to be operational in 2027.

Certification from Leading Cell and Gene Therapy CDMO Consulting Group

Dark Horse Consulting brings proven industry expertise to the ICMC certification process, having performed more than 60 cell and gene therapy CDMO selection projects and over 50 regulatory-style audits in the past four years. DHC's evaluation team includes former regulatory officials who apply the same rigorous standards used in official regulatory inspections, ensuring ICMC certification provides a meaningful audit of manufacturing capabilities.

"ElevateBio BaseCamp's ICMC certification demonstrates exactly the kind of comprehensive manufacturing capabilities that therapeutic developers need in order to reduce regulatory risk and accelerate their timelines," said Anthony Davies, Founder and CEO at Dark Horse Consulting. "Partners working with ElevateBio BaseCamp can expect standardized, reproducible manufacturing practices that have been rigorously evaluated against industry requirements, to ensure quality, compliance, and adherence to regulatory standards. This certification provides therapeutic developers with increased probability of technical success through verified manufacturing excellence."

About ElevateBio

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company applies its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines Life Edit, its gene editing and R&D technology business, with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

ElevateBio aims to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease. For more, visit www.elevate.bio or follow ElevateBio on LinkedIn or X.

Investor contact:
Catherine Hu
[email protected]

‪Media contact:
DJ Webster
[email protected]