Passage Bio, Inc., a genetic medicines company focused on therapies for rare, monogenic central nervous system (CNS) disorders, has entered into a long-term lease to support Chemistry, Manufacturing and Controls (CMC) lab operations for the company’s gene therapy programs. The new lab, scheduled to open in 2Q21 at the Princeton West Innovation Campus in Hopewell, NJ, will initially focus on state-of-the-art analytical capabilities, clinical assay development and validation, biomarker assay validation and clinical product testing to support both viral vector manufacturing and clinical development.

The opening of the CMC lab is part of Passage Bio’s strategy to expand its internal manufacturing capabilities to support its lead gene therapy programs as they move into the clinic and advance toward commercialization. The CMC lab complements the recent opening of Passage Bio’s dedicated CGMP manufacturing suite at Catalent. These investments provide the company with the foundation for an integrated manufacturing supply chain with capabilities to advance multiple gene therapy programs to support clinical trials worldwide.

The 62,000 sq.-ft. lab space is intended to support analytics, process development, quality control and pilot manufacturing. The 1.2 million-sq.-ft., multi-purpose research and development and biologic/pharmaceutical manufacturing campus also provides Passage Bio with expansion opportunities for additional lab space and CGMP manufacturing operations. Passage Bio plans to add more than 20 new positions in 2021 at the new lab.