At Utgene, mRNA drug substance production and mRNA-LNP drug product production at GMP scale is a comprehensive custom service that focuses on the large-scale production of mRNA drug substances and the formulation of LNP drug products in accordance with GMP regulations.

This service ensures the highest level of quality, consistency, and compliance with regulatory requirements for the development and manufacturing of mRNA-based therapeutics.

During GMP-scale production, the manufacturing process for mRNA drug substances is conducted on a large scale, allowing for the production of substantial quantities while maintaining strict adherence to GMP standards. Thorough quality control measures are implemented at every step to guarantee the purity, identity, and potency of the mRNA drug substance.

Following the production of mRNA drug substances, the GMP-scale production of mRNA-LNP drug products is initiated. The formulation process is meticulously optimized to achieve desirable characteristics such as particle size, stability, and encapsulation efficiency. Rigorous quality control measures are in place to ensure the consistency, reproducibility, and sterility of the mRNA-LNP drug products.

GMP-scale production involves a comprehensive compliance framework that encompasses facility design, equipment qualification, process validation, and robust quality control systems, quality standards and regulatory requirements. GMP documentation practices, including batch records and standard operating procedures, are meticulously maintained to provide a complete record of the manufacturing process and facilitate regulatory inspection.