The Challenge

To obtain regulatory approval and accelerate market entry, Paleo needed to demonstrate that their animal‑free myoglobins are safe and to optimise production yields. Assessing immunogenicity and toxicity and modelling production processes required expertise beyond the company’s core capabilities.

Our Approach

We assessed the safety and production of animal‑free myoglobins and provided regulatory evidence to accelerate market entry.

• Safety evaluation & literature review: Reviewed historical consumption and assessed allergenicity and toxicity to demonstrate low risk.

• Production modelling: Modelled production processes, identified genetic targets to improve yields and characterised host and recombinant products.

• Regulatory support & evidence: Provided comprehensive safety evidence and detailed reporting to support regulatory approval.

The Outcome

• Optimised production yields and demonstrated low allergenicity and toxicity.

• Confirmed that selected myoglobins are equivalent to those derived from meat, supporting regulatory approval.

• Enabled faster market introduction through strategic data support and clear reporting.

Why It Matters

Combining computational modelling with regulatory expertise accelerates the introduction of novel food products. Demonstrating safety and optimising production in silico reduces risk and speeds time to market.