Regulator validation supports broad application of insect-based biologics production technology. CrisBio offers significant advantages over existing production methods across human and animal health.
GMP certification of commercial production facility anticipated in 2021
Algenex SL, a biotech company backed by Cleon Capital and Columbus Ventures delivering disruptive technologies for recombinant biologics production, has taken significant steps towards full commercialisation of its CrisBio® platform through the first recommendation for approval by a global regulator of a biological produced with the system. CrisBio® is Algenex’ proprietary and patent protected Baculovirus vector-mediated expression platform that harnesses the power of insects to act as natural single-use bioreactors.
CrisBio® represents a new paradigm in biologics production, offering a quick, linearly scalable solution to meet the global demand for recombinant protein production without significant capex investment. On 17th June, the Committee for Medical Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) recommended for approval FATROVAX RHD, a recombinant subunit RHDV1 and RHDV2 vaccine for rabbits developed and manufactured using CrisBio®.
Regulatory validation of the first CrisBio product provides further momentum for Algenex as it expands use of the platform into a broader range of applications in both human and animal health. The Company is actively 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.
As well as broad applicability, CrisBio® offers benefits that include reduced production costs and increased productivity reaching gram per litre yields, significantly outperforming alternative baculovirus vector approaches. The CrisBio® platform is rapidly scalable, with Algenex’ capacity currently geared for commercial scale production. Algenex anticipates that its facilities will be fully GMP compliant by the end of the year.
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. We have already signed a number of commercial agreements including with Virbac for a major veterinary indication. 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 a biotech company backed by Cleon Capital and Columbus Ventures developing disruptive baculovirus-based technologies for the production of recombinant biologics. Algenex´ first two platforms, TopBac® and CrisBio®, are based on baculovirus-based expression systems and have demonstrated their capacity to transform recombinant protein production through a process that provides almost unlimited and immediate linear scalability of manufacturing, production flexibility, simplicity and versatility while being extremely cost efficient. The Company’s technology is highly applicable across a wide range of commercial product classes in both human and animal health.ç
Algenex has successfully produced >200molecules in collaboration with public and private partners, including multiple international pharmaceutical companies, including VLPs, monomeric vaccines, single domain antibodies, hormones, enzymes, growth factors and diagnostic reagents.