At Utgene, we have a state-of-the-art facility spanning 4000 square meters, designed and operated in strict adherence to Good Manufacturing Practices (GMP) standards. This commitment to quality and compliance ensures that we meet the highest industry standards and regulatory requirements. We could support our clients in GMP level mRNA drug substance (DS) and mRNA-LNP drug product (DP) manufacturing. Currently capacity around xx gram per batch.

Our integrated QA and QC team will assure the DS & DP quality. Our dedicated tech transfer team plays a critical role in ensuring seamless transfer of processes from our clients to our facility. With their expertise and experience, we guarantee that the production process is accurately replicated, maintaining consistency and reliability throughout.

We could support GMP runs for IND registration, and clinical materials supply up to phase 2. This comprehensive range of services allows our clients to confidently progress their mRNA-based therapeutics through the clinical development stages.