This project aims to identify safety-relevant parameters and evaluation methods for diverse scaffold and microcarrier materials used in cellular agriculture production.

There are various microcarriers and scaffold materials used in CM production. However, many are not categorized or standardized for safe use in food. For novel structures and engineered particles, there is no current regulatory framework to evaluate their identity or safety. Many scaffolds are designed to be included in the final product, thus it is important to create harmonized protocols addressing substance type, residual or degradation testing, morphological effects, as well as quality and safety.

A collaborative project facilitated by New Harvest, Vireo Advisors and co-led by Rohan Shirwaiker (Bezos Center) and Irfan Tahir (Prolific Machines)

(1) Develop agreed definitions and a classification scheme for scaffolds and microcarriers

(2) Identify quality and regulatory requirements (potentially to include: material type, morphology, end-use, source, production process, sterility process, and chemical composition)

(3) Develop harmonized methods to evaluate digestibility, degradation, residual presence, and conduct toxicological screening

(4) Assess digestibility and gastrointestinal fate based on material classification

(5) Degradation, leaching, and filtration examination in removed manufacturing by-products