EXCiPACT™ GMP certified produced cell culture media

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 and regulatory agencies such as U.S. Food and Drug Administration. Therefore, to mitigate such risks, PromoCell offers Excipient GMP-grade* cell culture media that are manufactured in an EXCiPACT certified environment.

A clean bench in a laboratory containing Excipient GMP-grade media in bottles and a high-volume media bag. A person in a lab coat is working at the bench, with only their gloved hands visible as they handle materials inside.

Why Excipient GMP-grade* media?

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 International Pharmaceutical Excipients Council (IPEC) international Good Manufacturing Practice (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.

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

Our Quality Management System is certified to the EXCiPACT™ GMP standard. The EXCiPACT™ certification framework for pharmaceutical excipients and Pharmaceutical Auxiliary Materials (PAMs) builds on our existing ISO 9001:2015 quality management system. It provides a GMP standard for pharmaceutical excipients or PAMs that is accepted worldwide.

What is Excipient GMP-grade*?

The EXCiPACT™ GMP certification covers the entire production process for our cell culture media and reagents (EQ-C-*/PE-C-*), ensuring a standardized environment, controlled equipment, and qualified raw materials. With the extended scope to include excipients and pharmaceutical auxiliary materials (PAMs), we have established a robust quality framework for materials indirectly used in pharmaceutical manufacturing, such as processing aids and buffers. This standard integrates relevant regulatory and quality requirements and thereby ensures consistent quality, safety, and regulatory compliance of excipients and PAMs. Therefore, this certification also ensures that our media undergo stringent quality control before product release. In addition to the EXCiPACT™ GMP certification, we also provide relevant documentation to support research in a regulated environment.

Read more about EXCiPACT™ GMP

Material category	What it is	Included in the final drug product?	Intentional patient contact?	Compliance framework	Typical examples
Pharmaceutical Auxiliary Materials (PAMs)	Processing materials used to manufacture APIs and medicinal products.	No (residual levels might be possible)	No	EXCiPACT PAMs Standard	Solvents, processing aids, cell culture media, pharmaceutical gases, etc.
Medical Devices	Instruments, implants, or in vitro tools/reagents used to diagnose, monitor, prevent, or treat health conditions.	Administration devices (e.g., syringes) are not included; cell therapies where cells are administered are included.	Yes	21 CFR 820; ISO 13485	Syringes, catheters, pacemakers, ex vivo grown cells reintroduced into patients, etc.
Pharmaceutical Excipients	Non active ingredients added to medicines to aid, improve stability and bioavailability, enhance patient acceptability, support delivery, and preserve product integrity during storage.	Yes	Yes	IPEC PQG; EXCiPACT Standard	Fillers, carriers that aid API delivery to the patient, etc.
Active Pharmaceutical Ingredients (APIs)	The pharmacologically active substance responsible for the medicine’s therapeutic activity.	Yes	Yes	21 CFR 210/211; EudraLex; ICH / OECD Guidelines	Antibody-drug conjugates, monoclonal antibodies, etc.

Table 1. Comparison of material categories, patient exposure and regulatory frameworks.

Material category	What it is	Included in the final drug product?	Intentional patient contact?	Compliance framework	Typical examples
Pharmaceutical Auxiliary Materials (PAMs)	Processing materials used to manufacture APIs and medicinal products.	No (residual levels might be possible)	No	EXCiPACT PAMs Standard	Solvents, processing aids, cell culture media, pharmaceutical gases, etc.
Medical Devices	Instruments, implants, or in vitro tools/reagents used to diagnose, monitor, prevent, or treat health conditions.	Administration devices (e.g., syringes) are not included; cell therapies where cells are administered are included.	Yes	21 CFR 820; ISO 13485	Syringes, catheters, pacemakers, ex vivo grown cells reintroduced into patients, etc.
Pharmaceutical Excipients	Non active ingredients added to medicines to aid, improve stability and bioavailability, enhance patient acceptability, support delivery, and preserve product integrity during storage.	Yes	Yes	IPEC PQG; EXCiPACT Standard	Fillers, carriers that aid API delivery to the patient, etc.
Active Pharmaceutical Ingredients (APIs)	The pharmacologically active substance responsible for the medicine’s therapeutic activity.	Yes	Yes	21 CFR 210/211; EudraLex; ICH / OECD Guidelines	Antibody-drug conjugates, monoclonal antibodies, etc.

Research use only
vs regulated products

The specifications and documents available for research use only (C-*)
and regulated products (EQ-C-* | PE-C-*).

View document

Request our GMP services

Table of research use only vs regulated products at PromoCell

*”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.

This material was initially created by RegMedNet and the original version can be found here.

FAQ

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 of the drug product, to protect, support or enhance stability of the API, 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.

Pharmaceutical excipient production should be carried out in accordance with the principles defined in Good Manufacturing Practices (GMP). With that in mind, a group of industry experts including European Fine Chemicals Group (EFCG), International Pharmaceutical Excipients Council (IPEC) and Pharmaceutical Quality Group (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 quality management system is suitable and that our cell culture media are manufactured according to the GMP guidelines. Therefore, our Excipient GMP-grade* media, such as PromExQ products, can be used (after the risk assessment at the user site) either as pharmaceutical excipients or PAMs. This ensures compliance with our raw material supply chain, production environment, production processes and storage conditions.

All cells isolated at PromoCell are obtained in accordance with the most stringent European and international ethical requirements. Our Quality Management System is ISO 9001:2015 certified, and our Excipient GMP-grade* cell culture media are manufactured under the EXCiPACT™ GMP standard. These certifications ensure that we consistently provide products and services that meet researchers’ requirements as well as applicable statutory and regulatory requirements. The following documentations and certification can be directly downloaded on our website: Quality Policy Statement, ISO 9001:2015 certificate, EXCiPACT™ certificate

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.

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 or xeno-free to chemically defined, to estimate and understand the associated implications for their intended applications. We can support you by providing comprehensive guidelines for the characterization and qualification of our cell culture media and reagents. Discover and download our Media & Reagents Specification Guide at: www.promocell.com/media-reagents-specifications-guide.html

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.