VALENCIA, Spain & BOSTON–(BUSINESS WIRE)–Curapath, a pacesetter within the design, growth, and customized manufacturing of polyamino-acid- and lipid nanoparticle (LNP) supply programs for therapeutics and vaccines, as we speak introduced the corporate has obtained 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 prescription drugs and medical gadgets in Spain and acts as a consultant of the European Medicines Company (EMA).
“The authorization of producing for scientific drug product from AEMPS is an thrilling milestone for our facility in Spain,” stated Robert Shaw, Chief Government Officer of Curapath. “The popularity of our capabilities by this regulatory physique signifies that we will produce drug substance and drug product for our prospects’ scientific packages. Importantly, it additionally supplies our prospects with the boldness to know Curapath is effectively positioned to assist their future business provide necessities.”
This approval builds upon Curapath’s business main experience within the customized design, growth, and manufacturing of polymer and lipid-based supply programs for cell remedy, gene remedy, and vaccines.
Curapath is a number one GMP-grade producer of polyamino-acid (PAA) and lipid-based nanoparticle encapsulation expertise for superior drug supply purposes together with mRNA, DNA, cell therapies, gene therapies, biologics, vaccines, and small molecule therapies. The Curapath crew of skilled biochemists and polymeric materials scientists are crucial companions within the drug growth and commercialization processes of a number of the main therapeutics corporations on this planet. The corporate affords contract growth and manufacturing companies together with preclinical growth, analytical characterization, expertise switch, GMP manufacturing, and fill/end companies. Be taught extra at www.curapath.com and on LinkedIn.