Landmark Bio
Landmark Bio is an advanced therapy contract development and manufacturing organization (CDMO) focused on process development, analytical development, formulation, and cGMP manufacturing for cell, gene, and nucleic acid therapies. The company operates a modular, reconfigurable 44,000 sq ft facility in Watertown, MA and provides services spanning discovery research through IND-enabling and clinical supply, supported by on-site quality control laboratories and regulatory/CMC consulting.
Industries
Nr. of Employees
medium (51-250)
Products
Cell & Gene Therapy Manufacturing
Provides cGMP manufacturing services for advanced cell and gene therapies including CAR-T, CAR-NK, viral vectors, and nanoparticles.
CMC Regulatory & Drug Development Consulting
Offers consulting on Chemistry, Manufacturing, and Controls (CMC) to support regulatory submissions and drug development strategies for advanced therapies.
IND-Enabling Services
Supports the critical steps and milestones required to achieve IND approval and clinical trial initiation for advanced therapies.
Viral Vector Manufacturing
Manufactures viral vectors including lentivirus, adeno-associated virus (AAV), retroviruses, and novel viruses for gene therapy applications.
Formulation Development
Develops and characterizes formulations, including RNA nanoparticle formulations, for advanced therapeutic applications.
Technology Development
Partners with clients to develop and translate novel therapeutic modalities and manufacturing technologies into clinical applications.
Cell & Gene Therapy Manufacturing
Provides cGMP manufacturing services for advanced cell and gene therapies including CAR-T, CAR-NK, viral vectors, and nanoparticles.
CMC Regulatory & Drug Development Consulting
Offers consulting on Chemistry, Manufacturing, and Controls (CMC) to support regulatory submissions and drug development strategies for advanced therapies.
IND-Enabling Services
Supports the critical steps and milestones required to achieve IND approval and clinical trial initiation for advanced therapies.
Viral Vector Manufacturing
Manufactures viral vectors including lentivirus, adeno-associated virus (AAV), retroviruses, and novel viruses for gene therapy applications.
Formulation Development
Develops and characterizes formulations, including RNA nanoparticle formulations, for advanced therapeutic applications.
Technology Development
Partners with clients to develop and translate novel therapeutic modalities and manufacturing technologies into clinical applications.
Services
Upstream and downstream process development, analytical method development and qualification, and side-by-side PD to cGMP transfer activities.
Rational nanoparticle and buffer/excipient design, cryopreservation development, stability optimization and sourcing of critical raw materials.
Modular cGMP manufacturing for cell therapies, viral vectors, mRNA/LNPs and extracellular vesicles with integrated QC and qualified facility utilities.
Closed isolator-based vial filling and associated fill & finish operations to support clinical and commercial supply.
QC laboratory testing for identity, purity, potency and safety including molecular, biophysical, microbiological and cell-based assays.
Early CMC strategy, CTD Module 3 preparation, regulatory risk assessment, and support for health authority interactions to accelerate IND/BLA pathways.
Upstream and downstream process development, analytical method development and qualification, and side-by-side PD to cGMP transfer activities.
Rational nanoparticle and buffer/excipient design, cryopreservation development, stability optimization and sourcing of critical raw materials.
Modular cGMP manufacturing for cell therapies, viral vectors, mRNA/LNPs and extracellular vesicles with integrated QC and qualified facility utilities.
Closed isolator-based vial filling and associated fill & finish operations to support clinical and commercial supply.
QC laboratory testing for identity, purity, potency and safety including molecular, biophysical, microbiological and cell-based assays.
Early CMC strategy, CTD Module 3 preparation, regulatory risk assessment, and support for health authority interactions to accelerate IND/BLA pathways.
Expertise Areas
- Cell and gene therapy manufacturing
- Viral vector production (AAV, lentiviral, retroviral)
- Process development and scale-up (upstream and downstream)
- Analytical method development and validation
Key Technologies
- cGMP manufacturing
- qPCR and ddPCR
- Flow cytometry (including nano/phenotypic cytometry)
- HPLC/UPLC
News & Updates
Announcement of an acquisition to scale capabilities for advanced therapy development and manufacturing.
NIIMBL award and NIST financial assistance to create a scalable platform for AAV vector manufacturing in collaboration with a partner company.
Opening of a state-of-the-art facility offering development, manufacturing and testing for cell and gene therapies.
Authored paper on optimization methods for in vitro transcription applicable to mRNA manufacturing.
Construction and opening of a 44,000 sq ft integrated biomanufacturing facility in Watertown, MA to support advanced therapy development and manufacturing.
Acquisition by Artis BioSolutions to expand manufacturing and commercialization capabilities.
Announcement of an acquisition to scale capabilities for advanced therapy development and manufacturing.
NIIMBL award and NIST financial assistance to create a scalable platform for AAV vector manufacturing in collaboration with a partner company.
Opening of a state-of-the-art facility offering development, manufacturing and testing for cell and gene therapies.
Authored paper on optimization methods for in vitro transcription applicable to mRNA manufacturing.
Construction and opening of a 44,000 sq ft integrated biomanufacturing facility in Watertown, MA to support advanced therapy development and manufacturing.
Acquisition by Artis BioSolutions to expand manufacturing and commercialization capabilities.