Bramble Bio
Cell therapy CDMO with 20+ years expertise, 16 Grade B cleanrooms, and 8,000+ patients dosed globally.
Bramble Bio specializes in cGMP manufacturing and process development for cell therapy ATIMPs, including autologous and allogeneic therapies, with 20+ years of expertise, 16 Grade B cleanrooms, and support for over 8,000 dosed patients across 46 countries. Headquartered in Europe.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Development (D)
Manufacturing (M)
Regulatory clearances
Services
About this organization
Overview
Bramble Bio is a Contract Development and Manufacturing Organization (CDMO) specializing in Advanced Therapy Medicinal Products (ATMP) and Advanced Therapeutic Investigational Medicinal Products (ATIMP) manufacturing. As part of Famicord Group, the company leverages over 20 years of expertise and a network of 15 laboratories to support innovative cell therapy products from preclinical development through clinical trials to commercialization.
Manufacturing & Process Development
- cGMP Manufacturing: 16 Grade B cleanrooms with modular design for flexible production across multiple cell types and volumes
- Autologous & Allogeneic Solutions: Customized manufacturing for personalized therapies and scalable production for larger patient batches
- Process Development & Optimization: Lab-scale proof-of-concept through GMP-compliant commercial production with tech transfer expertise
- Multi-Product Capabilities: Flexibility to handle different cell types and genetic modifications (including CAR-T and TCR-T) within a single facility
- Advanced Monitoring: Real-time data capture and environmental monitoring systems for enhanced in-process control
Cell Types & Therapies Supported
- Mesenchymal Stromal Cells (MSCs)
- Hematopoietic Stem Cells (HSCs)
- Natural Killer (NK) Cells
- Dendritic Cells
- Genetically Modified Cells (CAR-T, TCR-T)
Analytical & Quality Control
- Flow cytometry and potency assays tailored to product requirements
- Viability and functionality testing
- Microbial testing (sterility, mycoplasma detection)
- Endotoxin testing
- Stability testing throughout shelf life
Cryopreservation & Logistics
- Controlled-rate freezing (CRF) for cellular integrity preservation
- Ultra-low temperature storage for long-term stability
- Cold chain management across global distribution network
- 15 cryopreservation facilities throughout Europe, Middle East, and Asia
- Products distributed to 46 countries
Regulatory Support
- Regulatory strategy development aligned with EMA and ICH guidelines
- Clinical Trial Application (CTA) and IND submission support
- Quality documentation and gap analysis
- Proven track record: 20+ clinical trials supported, 2,100+ GMP batches released
Track Record
- Over 8,000 patients dosed with cGMP-manufactured products
- Support for up to Phase II clinical trials
- 20+ years of cell therapy manufacturing experience
Locations
Headquarters
Europe
Cryopreservation & Distribution Network
Europe, Middle East, Asia (15 facilities)
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