Pharma Focus America

Landmark Bio Enters Multi-Year Agreement for In-House Production of Galapagos' Oncology CAR-T Cell Therapy Clinical Programs

Monday, November 06, 2023

Landmark Bio, a collaborative initiative that brings together leaders from various sectors, such as industry, academia, and research hospitals, to expedite the development and industrialization of advanced genomic medicines, has recently established a multi-year strategic manufacturing partnership with Galapagos NV (Euronext & NASDAQ: GLPG), an innovative biotech company with operations in Europe and the United States.

According to the agreement, Landmark Bio will be responsible for Good Manufacturing Practice (GMP) manufacturing of clinical trial batches for Galapagos' developmental programs related to chimeric antigen receptor (CAR) T-cell therapies within the field of hematology-oncology, based in the Boston metropolitan area.

This manufacturing partnership aims to implement Galapagos' innovative decentralized CAR-T manufacturing model, which is designed to allow medical practitioners to administer CAR T-cells within a median timeframe of seven days following leukapheresis. This approach seeks to overcome significant limitations associated with current CAR-T treatments.

Landmark Bio, expressed enthusiasm for the collaboration with Galapagos and its role in supporting CAR-T clinical development programs in the United States. Zheng stated, "This strategic manufacturing collaboration underscores our commitment to expediting the delivery of life-saving therapies to patients and is a testament to our expertise in cell and gene therapy manufacturing."

Landmark Bio's extensive facility, covering 44,000 square feet, includes integrated spaces for various developmental and manufacturing activities. This includes laboratory areas for translational research and early-stage development, sections dedicated to process and analytical development, and spaces for technology innovation. The biomanufacturing segment comprises nine cleanrooms designated for the production of cell therapies, genome editing, viral vectors, mRNA, and lipid nanoparticles, along with capabilities for fill and finish processes and in-house Quality Control (QC) testing. Additionally, Landmark Bio offers complementary services, including drug development, regulatory consulting, program management, and other forms of support.

 

Source: prnewswire.com

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