ElevateBio has received comprehensive certification from the Initiative for Certification of Manufacturing Capabilities (ICMC) programme 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 the probability of technical success.
Through the certification process, DHC evaluates nine comprehensive systems, expanding upon the seven systems outlined in the 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.”
"ElevateBio BaseCamp's ICMC certification demonstrates exactly the kind of comprehensive manufacturing capabilities that therapeutic developers need 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 standardised, 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."