Accelerate Your Path To Clinic: Complimentary CMC Consultation Services For Cell Therapy Developers
In today’s competitive and capital-constrained cell and gene therapy environment, early decisions around Chemistry, Manufacturing, and Controls (CMC) can make or break a therapy's timeline, cost-efficiency, and eventual approval. Yet many emerging cell therapy companies struggle with CMC strategy until it becomes a bottleneck.
Excellos is offering a limited number of complimentary 60-minute CMC consultations designed to provide early-stage developers with strategic guidance before they engage a CDMO partner. This no-cost service is part of our commitment to scientific collaboration and building stronger foundations for future partnerships.
Why CMC Strategy Matters Early:
- Regulatory agencies are increasingly scrutinizing CMC sections in IND filings, often leading to delays due to avoidable issues.
- Key decisions around donor material, process comparability, and scalability are best made early—not during tech transfer.
- A proactive CMC strategy reduces risk, compresses timelines, and improves regulatory confidence.
What the Consultation Includes: Each 60-minute session is led by a member of our QC/ Regulatory leadership team, and may include:
- Review of high-level CMC strategy and current development phase
- Identification of potential gaps or misalignments in current plans
- Discussion around raw material sourcing, cleanroom compatibility (viral vs. nonviral), and regulatory expectations
- Recommendations for sequencing CMC activities in alignment with clinical milestones
Who It's For:
- Emerging biotech companies in pre-IND or early clinical planning stages
- Scientific and operational leaders seeking clarity on CMC readiness
- Teams evaluating CDMO partnerships but unsure where to beginWhat It's Not:
- This is not a substitute for formal regulatory consulting or tech transfer execution
- No proprietary data or NDAs are required for participation
Why Excellos: As a donor-to-dose CDMO with deep expertise in both upstream material and downstream manufacturing, Excellos brings a uniquely integrated perspective to early CMC planning. Our team understands the scientific, operational, and regulatory nuances that CGT developers face—and we’re here to support your success.