VALENCIA, Spain & BOSTON, January 26, 2023–(BUSINESS WIRE)–Curapath, a frontrunner within the design, improvement, and customized manufacturing of polyamino-acid- and lipid nanoparticle (LNP) supply methods for therapeutics and vaccines, immediately introduced the corporate has acquired accreditation as a GMP investigational drug product producer from the Spanish Company for Medication and Well being Merchandise (AEMPS). AEMPS is the regulatory company that oversees the standard, security, and efficacy of prescribed drugs and medical units in Spain and acts as a consultant of the European Medicines Company (EMA).
“The authorization of producing for medical drug product from AEMPS is an thrilling milestone for our facility in Spain,” stated Robert Shaw, Chief Govt Officer of Curapath. “The popularity of our capabilities by this regulatory physique signifies that we will produce drug substance and drug product for our clients’ medical applications. Importantly, it additionally supplies our clients with the boldness to know Curapath is nicely positioned to assist their future business provide necessities.”
This approval builds upon Curapath’s trade main experience within the customized design, improvement, and manufacturing of polymer and lipid-based supply methods for cell remedy, gene remedy, and vaccines.
Curapath is a number one GMP-grade producer of polyamino-acid (PAA) and lipid-based nanoparticle encapsulation know-how for superior drug supply purposes together with mRNA, DNA, cell therapies, gene therapies, biologics, vaccines, and small molecule therapies. The Curapath group of professional biochemists and polymeric materials scientists are essential companions within the drug improvement and commercialization processes of among the main therapeutics corporations on the planet. The corporate presents contract improvement and manufacturing companies together with preclinical improvement, analytical characterization, know-how switch, GMP manufacturing, and fill/end companies. Be taught extra at www.curapath.com and on LinkedIn.
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