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Algenex Announces GMP Certification
Madrid, 19 April 2022 - Algenex, a leader in the production of alternative proteins, backed by Cleon Capital and Columbus Ventures, announces that it has received the final audit report from the Spanish Agency for Medicines and Health Products (AEMPS) in which they confirm that Algenex complies with the principles of the Good Manufacturing Practices (GMP) for active substances of the European Union.
This certification provides validation of Algenex’s CrisBio® technology platform for the production of recombinant proteins within the quality standards of the European pharmaceutical industry.
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 by product protein in chrysalises. 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.
Aroha Sánchez, Head of Quality at Algenex, commented “We are proud to have certified the first GMP site in Spain based on CrisBio®, a versatile platform for obtaining recombinant proteins, meeting European quality standards for Active Pharmaceutical Ingredients. This important milestone confirms the status of CrisBio® as a genuine alternative to traditional methods of obtaining recombinant proteins that can be applied across a wide variety of markets including “cultivated food”, “one health”, enzyme production and diagnostics.”
Algenex’ technology platform was originally developed for the production of protein to the healthcare industry, a heavily regulated market. The European Medicines Agency (“EMA”) and the UK Veterinary Directorate issued marketing approval to a vaccine that incorporates CrisBio® technology in 2021, and the company currently operates a GMP pharma-grade facility in Madrid (Spain).
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Algenex is a biotechnology company backed by Cleon Capital and Columbus Venture Partners 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.
Algenex has successfully produced >200 molecules 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.
For more information, please visit http://www.algenex.com