RNAimmune, a biotech company focused on developing groundbreaking mRNA therapies, received approval from the U.S. FDA to begin Phase 1 clinical studies for an investigational new drug (IND). The drug product was supplied by Berkshire Sterile Manufacturing (BSM), using their new low-loss fill process. The process was key to overcoming product sensitivity challenges and reducing drug product loss to supply product for clinical studies in time. BSM’s low fill process was designed and validated i...