Enorna Biotechnology operates a fully integrated GMP facility designed for nucleic acid therapeutics. Our site complies with FDA, EMA, and NMPA regulations across quality systems, facility design, equipment validation, and operations. With dedicated suites for plasmid DNA, mRNA drug substance, LNP drug product, aseptic filling, and lyophilization, we provide flexible, scalable support from clinical to commercial supply.

Our integrated analytical and testing platform delivers comprehensive support throughout nucleic acid drug development and manufacturing. We provide complete analytical services across physicochemical, biochemical, microbial, and potency testing, covering the entire workflow from early-stage candidate screening to the method development, validation, release, characterization, and stability studies required for regulatory submissions (IND/BLA). We have established both pharmacopeial and client-specific methods for a wide range of molecules, including plasmid DNA, mRNA, circRNA, saRNA, and in vivo CAR drug substances and products.

To ensure efficiency and control, over 95% of testing is performed in-house (excluding specialized services such as sequencing and cell bank characterization). Our laboratories are equipped with industry-leading, high-sensitivity and high-resolution instrumentation, which underpin the accuracy, repeatability, precision, and reliability of all analytical results.