Algenex obtains GMP certification from Spanish Drug Agency for the manufacture of active Pharmaceutical ingredients
GMP is the highest quality seal that certifies that the Spanish biotechnology company complies with the Good Manufacturing Practices for the manufacture of pharmaceutical products in the European Union.

The Spanish biotech company Algenex SL, backed by Cleon Capital and Colombus Ventures, has just received from the Spanish Agency of Medicines and Health Products (AEMPS) the Good Manufacturing Practices (GMP) certification, an authorization that guarantees its quality for the manufacture of active Pharmaceutical ingredients, both for human and veterinary use. With the GMP certification, Algenex exceeds the highest quality standard in its processes and complies with the Good Manufacturing Practices established for the production of active substances in the pharmaceutical industry in the European Union.
This quality guarantee applies to the new facilities that Algenex inaugurated a year and a half ago in Tres Cantos, Madrid. GMP certification is the highest level of quality worldwide for the production of pharmaceutical substances and will enable Algenex to directly manufacture biological products and other substances using its patented CrisBio® and TopBac® platforms.
Both technologies are based on baculovirus expression systems and have demonstrated their ability to transform the production of recombinant proteins by using insects as natural bioreactors. A process that offers an alternative to manufacture these products at lower costs and with an almost immediate scalability compared to the use of traditional methods.
"From a strategic point of view, the Good Manufacturing Practices (GMP) certification is a significant achievement for the company as it validates Algenex's quality and production systems at the highest level which in turn guarantees the maximum quality of its products," says Aroha Sanchez, head of Algenex's Quality department. "The GMP is another step that demonstrates the enormous potential of our technology.
In 2021, the European Medicines Agency (EMA) and the UK Veterinary Medicines Directorate approved the marketing of a third party vaccine incorporating CrisBio® technology.
About Algenex SL
Algenex is a privately held biotechnology company, backed by Cleon Capital and Columbus Ventures, developing disruptive baculovirus-based technologies for the production of recombinant biologics. Algenex's first two platforms, TopBac® and CrisBio® have already demonstrated their ability to transform recombinant protein production through a process that provides almost unlimited and immediate manufacturing scalability, production flexibility, simplicity and high cost-effective versatility. Algenex's technology is applicable to a wide range of products for both human and animal health, as well as industrial biotechnology processes.
Algenex has successfully developed more than 200 molecules (including VLP-based vaccines, monomeric vaccines, diagnostic reagents, enzymes and growth factors) with public and private partners, including several international pharmaceutical companies. More information at www.algenex.com.