ElevateBio earns ICMC certification for gene and cell therapy capabilities

Biotech firm ElevateBio announced it has received certification from the Initiative for Certification of Manufacturing Capabilities (ICMC) program for viral gene delivery, non-viral gene delivery and cell therapy manufacturing at its flagship BaseCamp CDMO site in Waltham, Massachusetts.

The certification, administered by Dark Horse Consulting, assesses manufacturing capabilities in nine systems, expanding upon seven systems outlined in the U.S. Food and Drug Administration’s CBER Compliance Program Guidance Manual Chapter 45 for Biological Drug Products and incorporating European Union Directive 2003/94/EC standards. 

According to the company, the nine systems cover service business operations, quality, digital controls, facilities and equipment, materials, production, as well as packaging and labeling, laboratory controls, and commercial readiness.

ElevateBio said the independent evaluation included multiple days of on-site verification and review of hundreds of documents. The certification also supports commercial readiness at its BaseCamp Pittsburgh facility, which is under construction and expected to be operational in 2027, according to the announcement.

“This comprehensive ICMC certification represents the most rigorous third-party manufacturing evaluation available in our industry today,” Michael Paglia, chief technology officer at ElevateBio BaseCamp, said in a statement. “This certification across cell therapy, viral vector, and mRNA modalities underscores our unique capability to support a diverse range of advanced genetic medicine technologies.”

Anthony Davies, founder and CEO of Dark Horse Consulting, said ElevateBio BaseCamp’s certification demonstrates comprehensive manufacturing capabilities that can reduce regulatory risk and accelerate development timelines.