Cell Culture Media

Biothentix for Cell Culture Media Suppliers

Standardized, custom all-in-one test kits generate encoded CoA for harmonization with customers while protecting IP.

Biothentix for Cell Culture Media Suppliers

Standardized, custom all-in-one test kits generate encoded CoA for harmonization with customers while protecting IP.

The Problem:

Cell culture media formulations for Advanced Personalized Medicines and Regenerative Therapy can be complex and proprietary. Media Suppliers invest in optimization of critical components such as growth factors, cytokines, enzymes, and matrix proteins. Naturally, it is ideal to protect that intellectual property. In contrast, Manufacturers are under increasing regulatory pressure to gain greater insight and control over raw materials (e.g., ISO/AWI 20399-4:2025, USP<1043>, Ph.Eur. 5.2.12).

The Solution:

For cell culture media Suppliers, Biothentix generates encoded Certificates of Analysis for release testing. For Manufacturers, Biothentix can be used to enhance control over raw materials by multiplexed ID verification of critical components while ensuring lot-to-lot consistency, even for complex media formulations.

Encoded CoA:

For Suppliers, each Biothentix Raw Materials reagent kit can be customized to generate an encoded “fingerprint” for a specific media formulation. For release testing, the software generates an encoded CoA. Manufacturers can use the same Biothentix reagent kit to conduct rapid ID verification, in which the software automatically compares the lot tested to the encoded CoA.

Lot-to-Lot Consistency:

The system is highly quantitative, so media stability and lot-to-lot consistency relative to an established standard can be easily and automatically checked for incoming materials.