Custom GMP Services

Our Custom GMP Services bridge the gap between research and clinical implementation. We provide Excipient GMP-grade cell culture media manufacturing specifically designed for research institutions, biotech organizations, and red biotechnology innovators developing cell therapies and regenerative medicine approaches.

Our Custom GMP Services capabilities are developed within a Quality Management System in compliance with the EXCiPACT™ GMP certification scheme for pharmaceutical excipients. This ensures validated processes, full traceability, and comprehensive documentation for regulatory compliance. 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.

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

Explore our off-the-shelf PromoExQ portfolio.

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. We produce small-scale batches to test performance and compatibility within your process. This collaborative phase enables us to refine the formulation and ensure it meets all functional and regulatory requirements.

Once approved, we move forward together into full-scale production. All media manufacturing is carried out in our facilities with an EXCiPACT™ certified quality management system. Our focus is on ensuring consistency, quality, and regulatory alignment so you can move ahead with confidence.

With your custom media manufactured at full scale, we ensure it’s packaged securely and delivered reliably on time and in the format that fits your workflow. Your dedicated project manager remains available to support you with any follow-up needs, adjustments, or future projects.

Ready to transition from research to clinical applications? Contact us to learn how our Custom GMP Services can support your journey from discovery to clinical implementation.

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 customizable formulations and packaging options include:

• Tailored Excipient GMP-grade media: Modifications in formulation, quality control testing, and scalability, backed by 35 years of expertise in cell culture

   

   

   

• Flexible packaging: From bottles to custom-sized bags, we adapt to your process needs

   

• End-to-end efficiency: Streamlined processes with optimized media formulations

   

• Certified manufacturing environment: Manufacturing site with an EXCiPACT™ certified quality management system

The wide range of capabilities in our Custom GMP Services ensure flexibility to adapt to your specific needs.

• Customized formulation: Custom formulations based on our existing cell culture media formulations
• Batch-specific quality control testing: Standard testing in Certificates of Analysis (CoA), including color/clarity, microbial contamination, functionality, pH, osmolality, endotoxin level, and mycoplasma testing
• Batch volumes: 10-200 L capacity
• Packaging sizes: Standard packaging (125 mL, 500 mL bottle) or custom packaging (1 L bottle, 5-20 L media bags)
• Label customization: Manufacturing date and data matrix code options are available
• Traceability: Full compliance with requirements
• Stability studies: Available for customized medium formulation and packaging

• Personalized solutions: Media tailored to your specific cell type and research needs
• Scalability: Solutions designed to grow with your research and clinical applications
• Quality assurance: Rigorous testing and documentation to ensure compliance and consistency

We provide comprehensive documentation to support your risk assessments and regulatory approvals.

Our audit-ready GMP statements include:

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

Our team provides personalized guidance to navigate GMP requirements while advancing your research.

We offer:

• Simplified compliance: Understanding GMP requirements specific to therapeutic cell culture applications
• Accelerated research: Focus on advancing biotechnology while we handle to support the regulatory complexities
• Confidence in quality: Ensure your cell culture media meets the highest standards for clinical translation