Certifications & Compliance
ElevateBio has been recognized through comprehensive third-party certifications that validate our operational excellence and compliance with industry benchmarks.
// Certifications & Compliance
ICMC™ Certified for Clinical and Commercial Cell and Gene Therapy Manufacturing Capabilities
Our flagship BaseCamp facility in Waltham, MA has been certified by the Initiative for Certification of Manufacturing Capabilities (ICMC™) program for our viral gene delivery, non-viral gene delivery, and cell therapy manufacturing capabilities.
The ICMC certification is a rigorous audit administered by Dark Horse Consulting Group, that certifies ElevateBio’s compliant and scalable manufacturing capabilities for advanced therapies using U.S. and E.U. commercial-level evaluation standards.
Our partners can expect:
- Standardized, reproducible manufacturing processes that have been rigorously evaluated against industry benchmarks
- Accelerated timelines and increased probability of technical success
- Reduced regulatory risk
- Accelerated timelines and increased probability of technical success
BaseCamp is the First Genetic Medicine Manufacturing Business Certified Across Viral Gene Delivery, Non-Viral Gene Delivery, and Cell Therapy Products
We have been certified across all nine systems evaluated by the ICMC program, expanding on FDA’s CBER Compliance Program Guidance Manual Chapter 45 for Biological Drug Products and incorporating EU Directive 2003/94/EC standards.
Through this certification, we have demonstrated proficiency across nine critical systems:
- Service Business System
- Quality System
- Digital System
- Facilities and Equipment System
- Materials System
- Production System
- Packaging and Labeling System
- Laboratory Control System
- Commercial Readiness
Mike Paglia
Chief Technology Officer
ISO 45001 & 14001 Certified for Health, Safety, and Environmental Excellence
ElevateBio BaseCamp is certified to International Organization for Standardization (ISO) 45001 (Occupational Health and Safety Management Systems) and ISO 14001 (Environmental Management Systems) standards.
Partner with ElevateBio®
Wherever you are in your advanced therapy product lifecycle, we can strengthen and accelerate your development journey with our enabling technologies and unmatched process development and manufacturing capabilities.
// Work with us
