CDMO Services
Contract development and GMP manufacturing of advanced cell therapies. From concept to clinical use with a single reliable partner.
Contract Development & Manufacturing Organization
A CDMO (Contract Development and Manufacturing Organization) is a specialized entity that offers a complete range of services for the development and manufacturing of advanced therapeutic products. As a CDMO partner, GaiaCell enables biotech and pharmaceutical companies to access GMP-certified capabilities without the need for their own manufacturing infrastructure.
Our team of experts covers the full development cycle - from process optimization and analytical methods to technology transfer into a GMP environment, and manufacturing for clinical trials and commercial use.
Comprehensive CDMO Capabilities
Six key areas covering the complete development and manufacturing cycle of cell therapies
Process Development & Optimization
Development and optimization of manufacturing processes for cell therapies using cutting-edge biotechnological approaches. Determination of critical process parameters and quality specifications.
Technology Transfer to GMP
Structured transfer of processes from development to GMP manufacturing environment. Process validation, equipment qualification, and preparation of manufacturing documentation per EU GMP standards.
GMP Manufacturing for Clinical Applications
Manufacturing of cell therapies in GMP-certified cleanrooms for Phase I-III clinical trials. Complete traceability and quality control of every batch.
Process Scaling & Cost Optimization
Optimization of manufacturing processes for larger production volumes while maintaining quality. Reduction of unit costs through automation and process efficiency.
Analytical Method Development (QA/QC)
Development, validation, and implementation of analytical methods for quality control. Testing for sterility, endotoxins, mycoplasma, cell viability, and identity.
Stability Studies & Product Characterization
Comprehensive stability studies to determine the shelf life of therapeutic products. Characterization of critical quality attributes and specifications for release testing.
From Concept to Clinical Use
A structured approach to cell therapy development and manufacturing
Consultation
Needs analysis, technical feasibility, and project scope definition
Development
Process development and optimization, analytical methods, characterization
GMP Transfer
Validation, qualification, documentation for regulatory submissions
Manufacturing
GMP manufacturing, quality control, batch release for clinical use
Who Our CDMO Services Are For
We support organizations at various stages of cell therapy development
Clinical Research Teams
Research teams at universities and clinics developing novel cell therapies for clinical trials.
Biotechnology Companies
Startup and growing biotech companies that need GMP manufacturing without their own infrastructure.
Pharmaceutical Industry
Pharmaceutical companies expanding their portfolio with advanced therapy medicinal products (ATMPs).
Research Consortia
International projects and consortia for the development of innovative cellular and gene therapies.
Start a CDMO Partnership
Contact us to discuss your needs in cell therapy development and manufacturing. From concept to clinical application.