Curapath Receives Accreditation as a GMP Investigational Drug Product Manufacturer from the Spanish Agency for Medicine and Health Products
VALENCIA, Spain & BOSTON–(BUSINESS WIRE)–Curapath, a leader in the design, development, and custom manufacturing of polyamino-acid- and lipid nanoparticle (LNP) delivery systems for therapeutics and vaccines, today announced the company has received accreditation as a GMP investigational drug product manufacturer from the Spanish Agency for Medicine and Health Products (AEMPS). 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 (EMA).
“The authorization of manufacturing for clinical drug product from AEMPS is an exciting milestone for our facility in Spain,” said Robert Shaw, Chief Executive Officer 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.”
This approval builds upon Curapath’s industry leading expertise in the custom design, development, and production of polymer and lipid-based delivery systems for cell therapy, gene therapy, and vaccines.
Curapath is a leading GMP-grade manufacturer of polyamino-acid (PAA) and lipid-based nanoparticle encapsulation technology for advanced drug delivery applications including mRNA, DNA, cell therapies, gene therapies, biologics, vaccines, and small molecule therapies. The Curapath team of expert biochemists and polymeric material scientists are critical partners in the drug development and commercialization processes of some of the leading therapeutics companies in the world. The company offers contract development and manufacturing services including preclinical development, analytical characterization, technology transfer, GMP manufacturing, and fill/finish services. Learn more at www.curapath.com and on LinkedIn.