Landmark Bio, a collective endeavor bringing together leaders in industry, academia, and research hospitals to accelerate development and industrialization of next-generation genomic medicines, announced that it has signed a multi-year strategic manufacturing agreement with Galapagos NV, an innovative biotech company with operations in Europe and the U.S.
Under the terms of the agreement, Landmark Bio will perform GMP manufacturing of clinical trial batches of Galapagos’ development programs of chimeric antigen receptor (CAR) T-cell therapies in hematology-oncology in the Boston metropolitan area.
The manufacturing agreement aims at implementing Galapagos’ novel decentralized CAR-T manufacturing model, designed to enable clinicians to administer CAR T-cells within a median of seven days of leukapheresis, thereby aiming to address important limitations of current CAR-T treatments.
“We are excited to partner with Galapagos to support their CAR-T clinical development programs in the U.S.,” said Ran Zheng, CEO of Landmark Bio. “This strategic manufacturing collaboration is a testament to our expertise in cell and gene therapy manufacturing and underscores our commitment to bring more life-saving therapies to patients faster.”
Landmark Bio’s 44,000 square-foot fully integrated development and manufacturing facility includes laboratory space for translational research and early development, process and analytical development, and technology innovation. The biomanufacturing area is comprised of nine cleanrooms for cell therapies, genome editing, viral vector, mRNA, and lipid nanoparticle production as well as fill and finish and in-house Quality Control (QC) testing. In addition, Landmark Bio provides wraparound services such as drug development and regulatory consulting, program management and other support services.