Curapath, a company focused on the design, development, and custom manufacturing of polyamino-acid- and lipid nanoparticle (LNP) delivery systems for therapeutics and vaccines, has received accreditation as a GMP investigational drug product manufacturer from the Spanish Agency for Medicine and Health Products (AEMPS). The authorization recognizes that the company can produce drug substances and products. AEMPS is the regulatory agency that oversees the quality, safety, and efficacy of pharmaceuticals and medical devices in Spain and acts as a representative of the European Medicines Agency.
“The authorization of manufacturing for clinical drug product from AEMPS is an exciting milestone for our facility in Spain,” said Robert Shaw, CEO of Curapath. “The recognition of our capabilities by this regulatory body means that we can produce drug substance and drug product for our customers’ clinical programs. Importantly, it also provides our customers with the confidence to know Curapath is well positioned to support their future commercial supply requirements.”