Under the agreement, Landmark Bio will be responsible for performing Good Manufacturing Practice (GMP) manufacturing of clinical trial batches for Galapagos' development programmes involving chimeric antigen receptor (CAR) T-cell therapies in the field of haematology-oncology
Landmark Bio signs manufacturing agreement with Galapagos. (Credit: fernando zhiminaicela from Pixabay)
Landmark Bio has entered into a multi-year strategic manufacturing agreement with Galapagos, a biotechnology company known for its innovative operations in Europe and the US.
Under the terms of the agreement, Landmark Bio will be responsible for performing Good Manufacturing Practice (GMP) manufacturing of clinical trial batches for Galapagos’ development programmes involving chimeric antigen receptor (CAR) T-cell therapies in the field of haematology-oncology. The manufacturing will take place in the Boston metropolitan area.
The manufacturing agreement is a part of Galapagos’ pioneering decentralised CAR-T manufacturing model. This model is designed to streamline the process, allowing clinicians to administer CAR T-cell therapies within a median timeframe of seven days from leukapheresis. This approach aims to address critical limitations associated with current CAR-T treatments, including extended lead times.
Landmark Bio CEO Ran Zheng said: “We are excited to partner with Galapagos to support their CAR-T clinical development programmes in the US.
“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 extensive facility covers 44,000ft2 and offers a fully integrated space for development and manufacturing. The facility includes dedicated laboratory areas for translational research and early-stage development, process and analytical development, and technological innovation.
The biomanufacturing section of the facility features nine cleanrooms designated for various processes, including the production of cell therapies, genome editing, viral vectors, mRNA, and lipid nanoparticles. It also includes fill and finish capabilities and in-house Quality Control (QC) testing.
Beyond manufacturing, Landmark Bio offers a range of supportive services, including drug development and regulatory consulting, program management, and other complementary services to aid in the development and production of novel therapeutics.
The specific financial terms of the agreement between Landmark Bio and Galapagos have not been disclosed.