Custom GMP cell culture media manufacturing
Our Custom GMP Services provide in-house manufactured Excipient GMP-grade* media tailored to your application, process requirements, and production needs. Our services combine quality-controlled production with traceable documentation and manufacturing processes aligned with EXCiPACT™ GMP standards.
Whether you are developing cell therapies or regenerative medicine applications, we help you move from research to GMP workflows with reliable, compliant media solutions.
Advancing from research-grade to GMP manufacturing introduces critical challenges—from meeting strict regulatory standards to ensuring reproducibility, traceability, and consistent quality at scale. Our services are designed to help you address these requirements with confidence.
We'll manufacture GMP cell culture media tailored to your project.
Your benefits with Custom GMP Services
Our Custom GMP Services support key workflow requirements:
- Transition from research to GMP workflows through structured process adaptation
- Traceable manufacturing and documented quality control to support regulatory compliance
- Batch-to-batch consistency to support reliable clinical use
- Scalable custom media production aligned with your process requirements
Our Custom GMP Services capabilities
We deliver end-to-end GMP media customization to support your success in further manufacturing:
Media formulation built around your needs
- Custom formulations, based on proven PromoCell media compositions
- Animal component-free (ACF) and application-specific options
Compliance and regulatory assurance
- Excipient GMP-grade* media manufactured under a Quality Management System aligned with the EXCiPACT™ GMP certification scheme
- Manufactured for use as pharmaceutical excipients or pharmaceutical auxiliary materials (PAMs)
- Regulatory documentation support
Quality control and product testing
- Batch-specific quality control testing verifies product performance and manufacturing quality. The Certificates of Analysis (CoA) can include:
- Color/clarity
- Microbial testing
- Endotoxin and mycoplasma testing
- pH, osmolality, and functionality
Production and packaging options
- Batch volumes from 10-200 L
- Standard formats: 125 mL, 500 mL media bottles
- Custom format: 1 L media bottles, 5-20 L media bags
Additional customization services
- Label customization
- Stability studies for formulation and packaging
Applications of GMP-grade manufactured cell culture media
Our regulatory-friendly Excipient GMP-grade* cell culture media are optimized for advanced applications, such as:
- Cell therapy GMP media manufacturing
- Regenerative medicine workflows
- Research-to-clinical translation
- Clinical-stage process development
We support application-specific workflows across multiple primary cell types, including stem cells, fibroblasts, endothelial cells, muscle cells, and more.
Learn more: Role of GMP-grade* media in clinical transition
Reliable GMP-compliant manufactured media supports safe, scalable, and consistent manufacturing for a successful research-grade to clinical transition.
In an expert interview with RegMedNet, our Regulatory Affairs Manager / Material Compliance, Maximilian Gert-Kleint, discusses the importance of GMP-grade* cell culture media in cell therapy research.
Have specific requirements or questions? Let's define and develop the right GMP solution together.
*”GMP-grade” is a branding term used by PromoCell to denote reagents that are manufactured at the PromoCell manufacturing facility in Heidelberg, Germany, under strictly controlled processes to meet stringent product specifications and customer requirements. Reagents manufactured at PromoCell are produced according to EXCiPACT™ GMP standards, a quality management system that builds on our ISO 9001:2015 certification. Risk assessment procedures are carried out at the customer site.