For IND/IMPD-enabling studies, we manufacture well-characterized preclinical batches with GMP-representative CQAs—supporting tox, efficacy, and formulation-performance packages where required. We focus on reproducibility, documentation discipline, and analytics that translate into clinical-stage expectations. We manufacture preclinical nanoparticle batches that are designed to be predictive for clinical manufacturing. Using scalable, controlled processes and a CQA-driven approach, we produce reproducible batches suitable for efficacy and tox studies, stability testing, and reference material generation. Each campaign is supported by defined raw-material requirements, documented processing parameters, in-process controls.
