De-Risk Your Manufacturing Partnership
ElevateBio BaseCamp® Achieves Third-Party Certification for Commercial Manufacturing
“Out of 202 Complete Response Letters issued between 2020 and 2024, 150 (74 %) involved quality/manufacturing issues — including problems with manufacturing processes, facility inspections, or chemical, manufacturing and controls (CMC).” – Pharma Manufacturing
That’s why ElevateBio BaseCamp pursued third-party validation through the Initiative for Certification of Manufacturing Capabilities (ICMC™), administered by Dark Horse Consulting Group. We’re now the first manufacturer to achieve ICMC certification across viral gene delivery, non-viral gene delivery, and cell therapy products – giving partners independent verification of our manufacturing readiness before you invest time and resources in a partnership.
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Development Services
ICMC™ Certified for Clinical and Commercial Cell and Gene Therapy Manufacturing Capabilities
The ICMC certification is an independent, third-party audit that answers a critical question: Can this CDMO reliably manufacture my product at commercial scale while maintaining regulatory compliance?
ICMC confirms a CDMO’s commercial manufacturing readiness across key capabilities, building upon U.S. and E.U. commercial-level regulatory standards. Dark Horse Consulting Group – a trusted cell and gene therapy authority that has conducted over 60 CDMO selection projects for companies like yours – evaluates nine comprehensive systems that collectively determine commercial readiness.
This robust evaluation ensures a trustworthy assessment of BaseCamp’s manufacturing capabilities and commercial readiness.
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:
- Greater Likelihood of Technical Success: Passing the ICMC’s rigorous evaluation underscores BaseCamp’s unwavering commitment to quality, compliance, and manufacturing excellence. Our standardized, reproducible processes have evaluated against industry benchmarks, ensuring increased operational efficiency for you and your programs.
- Reduced Regulatory Risk: When former regulatory officials validate that a facility meets inspection standards across all critical manufacturing systems, you reduce the risk that quality or manufacturing deficiencies will trigger complete response letters, delay your regulatory submissions, or compromise your ability to supply patients.
- Accelerated Timelines: ICMC certification provides independent verification of our quality systems, facility infrastructure, digital systems, and production processes. This third-party validation significantly shortens your technical due diligence timeline, while also ensuring operational efficiencies so your program can advance quickly – without setbacks.
- Confidence Through Commercial Scale: ICMC doesn’t just evaluate individual capabilities. It assesses systems in their entirety to ensure commercial readiness. This means ElevateBio BaseCamp has the infrastructure and processes in place to scale from Phase 1 through commercial production.
- Multi-Modality Flexibility: Being certified across three major modalities – cell therapy, viral vector, and mRNA – reinforces our robustness in supporting a wide range of advanced genetic medicine technologies. As your needs evolve or expand, we have the flexibility to support your growth without needing to start from scratch.
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
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