EMA Issues Positive Opinion for CrisBio Developed Vaccine, Validating the Platform

The European Medicines Agency (EMA) has issued a positive opinion for a recombinant vaccine for rabbits that had been developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, representing a step forward for the full commercialization of the platform.

According to a June 22, 2021 press release, CrisBio offers a quick, linearly scalable solution that can meet the global demand for recombinant protein production without significant capex investment. The first regulatory validation of a biologic product produced with CrisBio will provide momentum for Algenex to expand the use of its platform into a broader range of applications in both human and animal health.

“The positive opinion of the EMA’s [Committee for Medicinal Products for Veterinary Use] CVMP for a CrisBio developed vaccine represents a significant regulatory validation for our platform and an important next step in bringing this new technology to full commercial light. We have already signed a number of commercial agreements including with Virbac for a major veterinary indication,” said Claudia Jiménez, CEO of Algenex, in the press release. “The CVMP decision further highlights the quality of our technology and underlines the potential of CrisBio to provide a versatile and robust alternative to bioreactor-based expression technologies across multiple applications in human and animal health, offering our partners significant benefits in terms of development speed, scalability, and gross margin.”