Concerns for the use of Basement Membrane Extract (BME)

There are publicly available protocols for the production of BME. If you're interested in learning more, you can find them via the following links: 

Hynda K. Kleinman (2001); Preparation of Basement Membrane Components from EHS Tumours 

Maura C. Kibbey (1994); Maintenance of the EHS Sarcoma and Matrigel Preparation  

Disclaimer: This information is based on publicly available protocols. We do not have insight into potential modifications made by companies producing BME. 

There is currently little information available on the sustainability aspects of producing BME. As part of our ongoing projects, we are working on assessing the environmental impact of three commonly used animal-derived laboratory products (ADPs): fetal calf serum (FCS),  BMEs, and animal-produced antibodies. 

The production of BME and other ADPs significantly impacts the environment by necessitating animal housing, specialized facilities, high energy consumption, and long-term storage requirements.  

For a broader perspective on sustainability within the 3Rs framework, we encourage you to explore the work conducted by NC3Rs on Sustainability and 3Rs. 

Both the EMA and FDA have established strict guidelines for the use of animal-derived materials in clinical applications, particularly emphasizing safety, risk assessment, and regulatory approval. The FDA focuses on ensuring that products derived from animals meet safety standards, including infection risk management. Similarly, the EMA requires high-quality standards for sourcing, testing, and manufacturing xenogeneic cell-based products, along with monitoring for potential zoonotic diseases. 

In the context of using Basement Membrane Extracts (BME), these guidelines highlight the biological incompatibility and variability of murine-derived materials with e.g.  human cell cultures. Such materials pose significant regulatory challenges for approval by both the EMA and FDA due to the risks associated with cross-species biological interaction and the potential for contamination.