Custom GMP Services for cell culture media

Custom GMP Services enable the manufacturing of PromoExQ media, our Excipient GMP-grade cell culture media, tailored to your application. This helps you bridge research, clinical-stage production, and further manufacturing.

Bringing cell-based research into clinical use requires significant time, resources, and high-stakes decisions, where early choices directly impact cost, timelines, and downstream success. Navigating non-GMP-compliant media, complex scale-up, and evolving regulatory requirements adds further risk, delays, and uncertainty.

At PromoCell, we leverage decades of experience supporting research institutions, biotech companies, and innovators in cell therapy and regenerative medicine, from discovery to advanced development. We understand the need for reliable, scalable, and regulatory-ready solutions, from the start. Our Custom GMP Services reduce risk, time, and cost by delivering consistent, fully documented media solutions, supported by expert guidance and regulatory insight—so you can move forward efficiently and with confidence.

Going beyond the standard media typically available, we offer an extensive range of specialized formulations tailored to a diverse array of cell types, including stem cells, endothelial cells, fibroblasts, and muscle cells.

Our broad range of capabilities gives you the flexibility to adapt media to your specific needs.

• Customized formulations: Tailored cell culture media based on proven PromoCell media compositions, helping you maintain performance while adapting your process for GMP manufacturing
• Animal component-free options: Available for improved safety, consistency, and regulatory alignment
• Batch-specific quality control testing: Verifies product performance and manufacturing quality. Standard testing in Certificates of Analysis (CoA), including color/clarity, microbial contamination, pH, osmolality, endotoxin level, and mycoplasma testing; additional customized quality control testing also available
• Flexible batch volumes: Flexible 10-200 L capacity, according to your manufacturing workflow
• Packaging sizes: Choose packaging formats that integrate smoothly into your manufacturing workflow and handling processes. Standard packaging (125 mL, 500 mL bottle) or custom packaging (1 L bottle, 5-20 L media bags)
• Label customization: Inclusion of manufacturing date for your documentation needs
• Traceability: Traceability compliant to EXCiPACT requirements

From research through clinical translation to market, our workflow of Custom GMP Services ensures reproducibility, reliability, and peace of mind. We work alongside researchers from various organizations, including biotech companies, pharmaceutical manufacturers, and CDMOs, to create a customized plan to meet your project’s unique needs.

We begin by listening to your needs and working together to map out your process. With a personal project manager assigned to you, we ensure a structured and transparent process from initial consultation to final delivery.

We believe the best solutions are built together. Our experts work closely with you to understand your specific requirements and identify the most suitable option from our comprehensive portfolio of GMP-grade products. When off-the-shelf products aren’t the perfect fit, we draw on our proven formulations to develop customized media tailored to your application.

Once we’ve defined your tailored solution, we move into pilot production. With our Pilot Evaluation Batch (PEB) program, we produce small-scale batches of cell culture media for you to test performance and compatibility with your process. This phase enables us to modify the formulation based on your results and confirm that all functional requirements are met before progressing to GMP-scale up.

Once approved, we move forward together into full-scale production. All media manufacturing is carried out at our Heidelberg, Germany facility under an EXCiPACT™ certified quality management system. We focus on consistency, quality, and regulatory alignment, so you can move ahead with confidence.

Your custom media is delivered on time and in the format your workflow needs. Your dedicated project manager stays with you for any follow-up, adjustments, or future projects.

Our Custom GMP Services capabilities are developed within a Quality Management System in compliance with the EXCiPACT™ GMP certification scheme for pharmaceutical excipients or pharmaceutical auxiliary materials (PAMs).

Whether you need Custom GMP Services or ready-to-use solutions from our PromoExQ portfolio of off-the-shelf Excipient GMP-grade media, our GMP offerings are built to meet the rigorous demands of clinical translation and further manufacturing.

We provide comprehensive documentation to support your risk assessments and regulatory approvals. Our audit-ready GMP statements include:

• Certificate of Analysis (CoA)
• Statements on GMP compliance, BSE/TSE status, GMO, and microbial and viral safety
• Certificate of Origin (CoO)
• Declaration of conformity

Our Custom GMP Services deliver flexible solutions to support your path to clinical application.

• Personalized solutions: Align media and packaging with your workflow requirements rather than adapting your process to standard offerings.
• Scalability: Support continuity as you move from early development to manufacturing.
• Quality Control: Ensure product functionality and consistency through rigorous testing and documentation.
• Dedicated support: Work with a dedicated project manager from project kick-off to delivery, providing consistent support throughout the project while reducing coordination effort and simplifying communication.
• Confidence in quality: Ensure consistency and manufacturing readiness with cell culture media manufactured under an EXCiPACT™ certified quality management system.
• Accelerated research: Focus on advancing biotechnology with our support in addressing regulatory complexities.