GMP resources

Navigating the transition from research to GMP-grade cell culture can be challenging, especially when developing innovative red biotechnology applications. Access our GMP resources, your go-to destination for expert insights and educational tools. From infographics to blog articles, we provide the knowledge you need to navigate complex GMP requirements with confidence.

Maximilian Gert-Kleint, Material Compliance Officer at PromoCell GmbH, is responsible for ensuring compliance with manufacturing and process standards, as well as raw material quality assurance. In an interview with RegMedNet, Maximilian discusses what it means for cell culture media to be GMP-grade and the significance of this compliance in the context of cell therapy manufacturing.

This expert interview covers:

• Key requirements for GMP-grade cell culture media
• Quality control standards
• Regulatory considerations for cell therapy production
• Best practices for maintaining compliance throughout the manufacturing process 

Understanding the technical specifications of GMP-grade media is crucial for successful cell therapy manufacturing. Our media specification guide provides comprehensive information about quality parameters, testing requirements, and documentation standards.

This guide helps you:

• Navigate complex regulatory requirements
• Select appropriate media for your applications
• Understand the importance of defined cell culture formulations
• Maintain proper documentation for regulatory submissions
• Answer frequently asked questions 

Our visual guide breaks down the key aspects of using GMP-grade products in cell therapy manufacturing. The infographic highlights the key benefits and requirements that make GMP-grade products crucial for the safe and effective development of all cell therapies.

Key topics covered:

• Understanding GMP-grade product standards and guidelines
• Patient safety considerations in cell therapy manufacturing
• Product and regulatory compliance requirements
• Documentation best practices

For more information about our GMP resources or to discuss your specific requirements, contact us at [email protected].