Rather than project-based consulting, we integrate as your fractional CMC department - attending team meetings, interfacing directly with your CMO partners, and taking ownership of CMC deliverables alongside your scientists.
CMC Development & Manufacturing Strategy for Cell & Gene Therapies
At PrimeRA Pharma Partner’s our Chemistry, Manufacturing, and Controls (CMC) leadership brings hands-on GMP manufacturing experience spanning clinical-stage development through commercial launch, including contributions to some of the first approved gene and cell therapies globally. We understand that an effective CMC strategy for ATMPs demands deep expertise in viral vector and cell therapy manufacturing, along with a strong understanding of FDA and EMA requirements.
Explore Our CMC Capabilities
Our CMC Capabilities
1
Viral Vector Manufacturing Strategy
- Lentiviral vectors (in vitro and in vivo use)
- Retroviral vectors
- AAV vectors
- GMP-grade production from Phase I through commercial scale
- Tech transfers to CMO sites across UK, EU, and US
2
Cell Therapy Manufacturing Development
- Gene-modified cell therapy, particularly autologous cells (T-cells and HSPCs)
- Process development and optimisation from clinical to commercial scale
- Manufacturing consistency and comparability strategies for patient-specific products
- Quality systems tailored to cell therapy complexity
3
CMC Regulatory Documentation
- IMPD/Module 3 compilation for CTA and IND submissions
- CMC sections for MAA and BLA
- Strategy and briefing book drafting for Agency aligns on CMC challenges: e.g. comparability protocol, specification, raw material sourcing
- Agency responses to CMC-specific questions from FDA and EMA
4
Process Development & Scale-Up
- Clinical-to-commercial transition planning
- Process optimisation whilst maintaining product comparability
- Analytical method development and validation
- Critical quality attribute (CQA) identification
5
CMO Selection & Tech Transfer
- Contract manufacturing organisation (CMO) evaluation and selection
- Tech transfer oversight for viral vector and cell therapy manufacturing
- GMP manufacturing readiness assessment
- Facility design consultation for ATMP production
6
Supply Chain & Distribution Strategy
- Demand and supply planning for autologous therapies
- Distribution challenges specific to temperature-sensitive ATMPs
- Pre-launch commercial readiness activities
- Post-approval manufacturing lifecycle management
Our CMC Expertise
Our team has directly managed GMP production facilities, led manufacturing teams, and produced clinical-grade viral vectors and cell therapy products. This hands-on experience means we understand the practical realities of ATMP manufacturing—from cell sourcing challenges to batch release decisions.
We've guided CMC strategy across the full development arc — from academic spinout and first-in-human programmes through to commercial launch and post-approval manufacturing changes.
For early-stage teams, this means building CMC frameworks that are fit for purpose at IND/CTA stage without over-engineering for a phase you haven't reached yet. Getting the foundations right early — starting materials, comparability strategy, manufacturing process definition - saves significant time and cost later.
As programmes mature, this includes:
- Managing late-stage CMC timelines and regulatory milestones
- Leading pre-launch commercial manufacturing activities
- Navigating post-approval comparability assessments
- Supporting supply chain scale-up for autologous therapies
Having prepared CMC documentation for both FDA (IND, BLA) and EMA (CTA, MAA) submissions, we understand how to position your manufacturing strategy to satisfy both agencies with a coordinated global approach. Our teams in the US and EU ensure your CMC narrative remains consistent across jurisdictions.
Our Engagement Model
Senior CMC Expertise
Access experienced CMC leadership without full-time headcount costs. Our team becomes your CMC department, providing strategic guidance and hands-on support.
Continuity Across Development
We maintain institutional knowledge as your programme evolves from Phase I through commercial launch, eliminating the need to re-establish context with new consultants.
Scalable Partnership
Our engagement scales with your needs - deeply embedded during critical CMC milestones, then adjusting during quieter periods whilst maintaining continuity.
Who We Work With
Early-Stage Biotechs
For companies transitioning from research-grade to GMP manufacturing, we help you design your first GMP-compliant manufacturing process, prepare IMPD/Module 3 for initial CTAs/INDs, select and qualify your first CMO partner, and establish quality systems appropriate for your stage.
Academic Spinouts
We understand the unique challenges of moving from academic research environments to regulated GMP production. We help translate research protocols into GMP-compliant processes, establish QC testing strategies that satisfy regulatory requirements, and navigate the EMA's ATMP Pilot for Academics programme.
Late-Stage Programmes
For programmes approaching commercial launch, we provide commercial manufacturing strategy and scale-up planning, comparability assessments for process changes, supply chain optimisation for autologous therapies, and complete CMC sections for MAA/BLA submissions.
Ready to Discuss Your CMC Strategy?
Whether you're designing your first GMP manufacturing process or optimising a late-stage commercial strategy, our team brings the hands-on manufacturing experience and regulatory intelligence to advance your ATMP programme efficiently.
Schedule a Consultation