ElevateBio BaseCamp Achieves First Multi-Modality ICMC Certification in Commercial CGT Manufacturing

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ElevateBio, a technology-focused cell and gene therapy company, announced on Aug. 13, 2025 that its BaseCamp manufacturing facility in Waltham, Mass., has achieved certification under the Initiative for Certification of Manufacturing Capabilities (ICMC) program for the facility’s viral gene delivery, non-viral gene delivery, and cell therapy manufacturing capabilities. This certification marks a first for a genetic medicines manufacturer across these multi-modal manufacturing capabilities (1).

The ICMC certification, administered by Dark Horse Consulting, assesses nine critical manufacturing systems against both FDA and European Union (EU) commercial-level standards. The program aims to address persistent industry challenges, including regulatory risk reduction, accelerated development timelines, and improved technical success rates.

“This comprehensive ICMC certification represents the most rigorous third-party manufacturing evaluation available in our industry today,” said Michael Paglia, chief technology officer, ElevateBio BaseCamp, in a company press release (1). “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 [messenger RNA] 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.”

Nine-system evaluation for commercial manufacturing readiness

ICMC’s framework expands upon the FDA’s Center for Biologics Evaluation and Research (CBER) guidelines (2) and incorporates EU Directive 2003/94/EC standards (3). The nine systems evaluated at the BaseCamp facility include:

• Service business system valuates project management, technology transfer processes, and business continuity planning—essential for maintaining progress in complex manufacturing partnerships.
• Quality system ensures robust quality frameworks that reduce approval risks and support timely regulatory submissions.
• Digital system verifies data integrity and cybersecurity, safeguarding intellectual property and regulatory compliance.
• Facilities and equipment system confirms controlled manufacturing environments and cross-contamination prevention measures tailored for advanced therapies.
• Materials system assesses supply chain management from procurement through release, ensuring starting material consistency for high-precision processes.
• Production system validates reproducible aseptic manufacturing processes that ensure safety and efficacy from early to late-stage production.
• Packaging and labeling system maintains product identity and chain of custody throughout manufacturing.
• Laboratory control system reviews testing and verification protocols vital for quality release decisions.
• Commercial readiness confirms scale-up capabilities and process validation needed for transition from clinical to commercial production.

The certification process involved several weeks of evaluation, multiple on-site inspections, and review of hundreds of documents. These systems also set the operational framework for ElevateBio’s upcoming BaseCamp facility in Pittsburgh, Pa., scheduled to be operational in 2027.

Third-party rigor in manufacturing capability assessment

Dark Horse Consulting’s evaluation team, composed in part of former regulatory officials, applies inspection standards equivalent to those used in official audits. In the past four years, the firm has conducted more than 60 cell and gene therapy manufacturing partner selection projects and more than 50 regulatory-style audits.

"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, Dark Horse Consulting, in the press release. "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."

The awarding of this certification to ElevateBio offers a benchmark for evaluating contract development and manufacturing organizations in the cell and gene therapy sector, which continues to quickly advance. As therapeutic pipelines expand, verified manufacturing readiness across multiple delivery modalities is increasingly essential to meeting global demand and regulatory expectations.

References

1. ElevateBio. ElevateBio BaseCamp Achieves ICMCT Certification for Commercial Cell and Gene Therapy Manufacturing Capabilities. Press Release. Aug. 13, 2025.
2. FDA. Inspection of Biological Drug Products (CBER) 7345.848. FDA.gov (accessed Aug. 14, 2025. https://www.fda.gov/vaccines-blood-biologics/enforcement-actions-cber/compliance-programs-cber
3. EU Directive 2003/94/EC. Principles and Guidelines of Good Manufacturing Practice in Respect of Medicinal Products for Human Use and Investigational Medicinal Products for Human Use (October 2003). https://eur-lex.europa.eu/eli/dir/2003/94/oj