Cultured meat products are novel in the market, there are no regulatory and CMC guidelines specifically dedicated to them. Therefore, the regulatory and development strategy must be customized on a case-by-case basis.
In this case study, we explore how VCLS supported a company trying to gain approval for its cultured meat product, developed using 3D bioprinting technology. The company was in the process of establishing a manufacturing facility to ensure Good Manufacturing Practice (GMP)-compliant development and scale-up. We provided support on overall regulatory strategy and roadmap, especially interactions with regulatory authorities in the US, EU, and Singapore, as well as specific Chemistry Manufacturing and Controls (CMC) requirements for cultured meat products in these regions.
Additionally, we provided guidance on the product development challenges and associated risks.