Media manufacturers have mature quality control and manufacturing procedures in place and trusting these will allow reduced identification testing at the biomanufacturer site. However, the main issue is the complexity and range of the chemical properties of concentrations, which makes it difficult to use just one testing method. As a result, raw material testing in many companies is relatively basic.
Also, regulatory bodies expect an incoming test for cell culture media, but no ‘magic’ test will say that a medium contains a specific raw material.
For these reasons we have written Media fingerprinting of cell culture media, which contains a standardized analytical test method suite and three-tiered approach to shed light on this area and discuss the complexities around media fingerprinting and their impact.
A media fingerprinting toolbox
The paper covers the analytical methods commonly used and discusses the techniques available that will help readers build a media fingerprinting toolbox. For each technique, it lists the method type (qualitative or quantitative), the scientific principle used, advantages/disadvantages, and the measured components.
It also discusses analytical method best practices, i.e., basic, spectroscopy and optical. Creating best practices around these common methods gives industry a good perspective on what and how they are used.
A host of benefits
Using fingerprinting and better characterization of the materials outlined in this paper will bring a host of benefits. A standardized fingerprinting test suite will improve raw material attribute understanding, align expectations across suppliers and manufacturers, and make case studies and knowledge easier to share. It will also allow more accurate identification testing for media and other non-compendial materials, simpler qualification across suppliers, and leaner investigations.
“The paper will provide the necessary guidance to support a transparent collaboration with our suppliers in terms of media testing,” said Amandine Calvet, Senior Scientist, Upstream-Late Stage Development, Media, Boehringer Ingelheim Pharma GmbH & Co. KG. “This means obtaining the informative data from our cell culture media, that will promote improved process understanding, control, and sustainability.”
The paper will aid material science/analytical groups that focus on advanced characterization methods for raw materials and the quality control teams that release the media. More broadly, it will also interest end-users and media manufacturers.
Not everybody will have specialist knowledge of analytical methods, so the paper will help clarify their thinking and see what common methods are available and the advantages of each – depending on the end-user’s goal, they can choose whichever method suits their purposes.
The primary scope of the paper is complex chemically defined cell culture media, followed by supplements and certain undefined materials, e.g., hydrolysates. Compendial materials, cleaning agents, single-use systems, and process aids are out of scope.
The paper illustrates how this work forms part of BioPhorum’s Raw Materials Vision and Mission, and how it sits within its Raw Materials Strategic Framework as it seeks to harmonize industry and analytic methods by providing guidance and recommendations. In addition, BioPhorum members can download the implementation recommendation pack via iMeet.