EXCiPACT™ GMP certification and cell culture media manufacturing

A crucial step when developing new drugs and cell therapies and during development of new cosmetics or cell-based food production, is the translation of a technology from the research laboratory to clinical use in the real world, and subsequently commercial manufacturing.  To ensure this step goes well, understanding and evaluating potential raw material risks of media and reagents is key when working with products in a regulated environment.

Cell culture media s based on regulatory requirements

To ensure the transition from bench to commercial manufacture goes smoothly when developing cell-based therapies, the earliest stages of preclinical research should include cell culture media and reagents that are manufactured in compliance with IPEC international GMP guidelines.

GMP grade* cell culture media are vital for restraining safety and quality, complying with strict standards, supporting cell viability, functionality, and consistency in manufacturing processes.

Created in cooperation with RegMedNet.

Our entire product development pipeline is designed to enable compliance with these regulatory guidelines. We are proud to support you from the first step in preclinical development to development of the final therapy.

Our Commitment to Quality

Learn more about our ISO and EXCiPACT™ GMP certification 

Our Quality Management System is certified according the EXCiPACT™ GMP standard. The EXCiPACT™ certification scheme for pharmaceutical excipients provides a GMP standard that is accepted worldwide and builds on our existing ISO 9001:2015 quality management system. In addition, this is fully aligned with the American National Standard for Good Manufacturing Practices according to NSF/IPEC/ANSI 363. The EXCiPACT™ GMP certification covers the production of our entire cell culture media and reagents portfolio by using the highest quality raw materials and in adherence to GMP standards. With this certification we can support you to work with our products under a regulated environment.

In addition, we own our entire manufacturing process, meaning we can create customized products to meet your exact needs both during development and at larger scales for later manufacturing.

Cell culture media and reagents with certification accepted worldwide

Benefits of our GMP service:  

  • Minimizes risk
  • Streamlined definition of raw material specifications and documentation
  • Reduces regulatory burden
  • Saves on cost and time

Read more about EXCiPACT™ GMP                 

CONTACT US FOR MORE INFORMATION

How Does Our GMP Service Work?

GMP services provided by PromoCell.

Standard and regulated products

To view the specifications and documents available for standard (C-*)
and regulated products (EQ-C-* | PE-C-*) click here.

 

 

REQUEST OUR GMP SERVICES

Why PromoCell

With over 30 years of expertise, we help scientists discover more with our comprehensive portfolio of world-class cell culture and cell biology products. Along with support from experts who share your fascination for science, we empower scientists and researchers around the world to deliver vital and ground-breaking work. To do great research, you need high-quality products you can trust. Therefore, commitment to quality is at the heart of everything we do.

With our GMP-service, we meet the growing demand of researchers planning to work with our products under a regulated environment. Regulatory requirements can be very specific for individual countries and their local authorities. Therefore, it is crucial to collaborate with a partner who can provide the highest standard of products along with a customized regulatory support.

Your science is moving the world forward – and we’re here to help.

Find out more about PromoCell

FAQ

*”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.

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