Algenex receives EMA validation for insect-based manufacturing platform
The biotech company received the recommendation from the European Medicines Agency (EMA) for its CrisBio platform and claims that its insect-based manufacturing platform offers advantages over traditional bioreactor-based expression technologies.
The recommendation was provided for Algenex’s platform to produce vaccines for human use and arrived only a few days after the EMA had reached the same conclusion for the technology to be used for veterinary purposes.
CrisBio is a baculovirus vector-mediated expression system that utilizes the chrysalises of lepidoptera insects to produce recombinant protein. Algenex states that the platform could be applied to develop a range of product classes, including vaccines, antibodies, hormones, enzymes, growth factors and diagnostic reagents.
A spokesperson for Algenex told BioPharma-Reporter that the advantages possessed by the platform include “Increasing production yields through the transcription of the mRNAs by using new promoters and other genetic regulators (such as Ac-ie-01 and hr1).”
They continued to suggest that the platform is able to improve cell viability, by inhibiting apoptosis, and by reducing proteolysis thereby conferring more stability to the produced recombinant proteins.
Algenex stated that its own facility, which uses CrisBio technology, is currently scaled for commercial production and it expects to be fully good manufacturing practice (GMP) compliant by the end of 2021.
The spokesperson suggested that using the platform at commercial scale is possible due to it possessing “almost unlimited scalability.”
“We increase scale by inoculating more chrysalises, that have millions of cells in perfect physiological conditions to express the protein they have been programed to produce through the infection with the baculovirus,” they added.
The platform operating in this way also means that it can be scaled up without culture conditions being adapted, potentially resulting in a faster scale up of the overall process. Algenex stated that this can reduce cost, as well as also offering savings on capex and culture media.
Growing interest in insect platform
Algenex is not the only company that is exploring the potential to use insect manufacturing platforms to provide an alternative to bioreactor-based technology.
Last year, Lonza launched its own insect platform that was designed to produce adeno associated viruses (AAVs) to support gene therapy development.
While Novavax has utilized an insect cell baculovirus system to produce its recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine.