mRNA-LNP IND-Enabling CMC

ProBio provides comprehensive process development support, including small-scale testing, upstream and downstream process optimization, formulation studies, and demonstration and verification runs to enable efficient scale-up and clinical readiness.

ProBio delivers comprehensive analytical development and quality control support, including product characterization, in-process testing, method development and qualification, reference standard establishment, lot release testing, and stability studies under long-term, accelerated, and stress conditions to ensure robust product quality and IND-enabling readiness.

ProBio provides comprehensive regulatory support for global IND submissions, including FDA, NMPA, EMA, and other major regulatory agencies. Backed by experienced in-house regulatory and CMC experts, we help clients navigate evolving requirements, prepare submission-ready documentation, and efficiently address agency questions to accelerate clinical advancement.