Insect-based vaccine production platform validated by EMA
pharmafile | June 22, 2021 | News story | Manufacturing and Production | Insect-based, Vaccine, production, technology
Algenex SL has announced EMA validation of a recombinant subunit vaccine produced by their baculovirus vector-mediated expression platform, that harnesses the “power of insects” to act as natural single-use bioreactors.
CrisBio was used by Algenex to produce and manufacture a subunit RHDV1 and RHDV2 vaccine for rabbits, a milestone, the company stated, that will provide momentum towards expanding the technology into both human and animal health.
Currently Algenex is working with its partners to apply technology to a wide range of product classes including vaccines, single domain antibodies, hormones, enzymes, growth factors, and diagnostic reagents.
The platform offers a range of benefits, particularly reduced production costs and increased productivity, reaching gram per litre yields that significantly outperform alternative baculovirus vector approaches.
Claudia Jiménez, CEO of Algenex, said: “The positive opinion of the EMA’s 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.
“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.”
Algenex´ first two platforms, TopBac and CrisBio, are based on baculovirus-based expression systems (BEVS) which are eukaryotic expression systems that are known to significantly increase the speed and versatility of expression of a variety of protein families allowing the acceleration of development times of protein-based pharmaceutical or diagnostic products.
CrisBio uses pupae from the moth Trichoplusia ni, also known as the Cabbage looper, which is the natural host of the AcMNPV baculovirus vector used in the commercial vaccine production.
Chrysalises are reared under special conditions and then robotically infected with genetically modified denominated baculovirus, which is then replicated in the insect’s cells. In under a week the chrysalises generate the vaccine antigen which is then extracted, purified and formulated into vaccines.
Kat Jenkins
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