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 transition 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.

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 certified 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 processes of our dedicated cell culture media and reagents portfolio (EQ‑C‑*/PE-C-*), operating in maintained environment and with controlled equipment, utilizing qualified raw materials, and testing with a stringent quality control for product release. With this certification and additionally provided regulatory relevant documentation 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.

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?

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

• What are raw materials or ancillary materials and how do these differ from pharmaceutical excipients?

  Raw materials come in contact with the cell or tissue product during manufacturing but are not intended to be part of the final product. For example, cell culture media and reagents can be used in research and production of cell-based drugs and therapies. In this case they are defined as raw materials. During drug, cosmetic, and cell therapy development, the quality of raw materials must be carefully considered as they may have an effect on the efficacy of the final product and subsequent safety for the patient [1].

  The nomenclature for raw materials differs between the regions. The terminology “raw material” is used by European regulators.  In other regions the synonymous term ancillary material is used.

  Raw materials or ancillary materials are commonly labeled as “not for use in clinical or diagnostic procedures” or “for ex vivo use only and not intended for human in vivo applications”.

  Pharmaceutical excipients are substances that are included in a pharmaceutical dosage form not for their direct therapeutic action, but to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability. They may further assist in the effectiveness and/or delivery of the drug in use and maintain the integrity of the drug product during storage.

  [1] Solomon J, Csontos L, Clarke D, Bonyhadi M, Zylberberg C, McNiece I, Kurtzberg J, Bell R, Deans R. Current perspectives on the use of ancillary materials for the manufacture of cellular therapies. Cytotherapy. 2016 Jan;18(1):1-12.

• What is the EXCiPACT™ GMP certification?

  Pharmaceutical excipient production should be carried out in accordance with the principles defined in the Good Manufacturing Practices (GMP). With that in mind, a group of industry experts including EFCG, IPEC and PQG worked together to develop the EXCiPACT™ certification scheme for pharmaceutical excipient suppliers.

  EXCiPACT™ is a non-profit organization that oversees and operates an independent, high-quality,  third-party certification system. This certification system is available to pharmaceutical manufacturers and distributors around the world.

  To achieve EXCiPACT™ GMP certification, we demonstrated that our pharmaceutical excipients are manufactured according to these GMP guidelines, as well as ensuring compliance in our raw material supply chain, production environment, production processes and storage conditions.

  Learn more about EXCiPACT™

• Can I access your ISO and EXCiPACT™ Certification?

  All our products meet the strictest European and international ethical standards, and our Quality Management System is certified according to ISO 9001:2015 certification and the EXCiPACT™ GMP standard. These certifications ensure that we consistently provide products and services that meet researchers’ and applicable statutory as well as regulatory requirements while also covering the GMP requirements according to NSF/IPEC/ANSI 363.

  The following documentations and certification can be directly downloaded on our website

  • Quality Policy Statement
  • ISO 9001:2015 certificate
  • EXCiPACT™ certificate
  • ANSI 363-2016 certificate

  Download the respective documents

• Where can I find the supporting documents and the material safety data sheet for your products?

  Using the product lot number the Supporting Documents can be downloaded at: www.promocell.com/eq-certificates

  The Material Safety Data Sheet (MSDS) can be directly downloaded from our website on the product page.

• How do you define your media & reagents specifications?

  Choosing a suitable culture medium is crucial factor for in vitro cell cultivation and significantly affects the success of cell culture experiments, from the first step of development and when transitioning to clinical applications. Due to specific requirements of primary cells and each researcher’s application, we provide a wide range of advanced media formulations.

  Therefore, it is essential for researchers to have a clear understanding of how to define the specifications of our cell culture media and reagents, from serum-free (SF) or xeno-free (XF) to animal component-free (ACF) or chemically defined, to estimate and understand the associated implications for their intended applications. We can support you by providing a comprehensive guideline for the characterization and qualification of our cell culture media and reagents.

  Discover and download our Media & Reagents Specification Guide

• What is the limitation for the intention of use for your products?
  • Our standard research products are intended for in vitro research use only.
  • Our Excipient-GMP grade* and regulated media are intended for research use or further manufacturing. They are not intended for direct administration to humans or animals.

*”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.