Biologics

End-to-end development services for cell and gene therapies, proteins and peptides, monoclonal antibodies, and antibody-drug conjugates

Integrated Biologics Development — From Cell Line to Clinic

MRIGlobal provides GMP-compliant biologics development across the full product lifecycle, from genetic engineering and cell line development through analytical characterization, formulation, and stability testing. Our scientists bring deep expertise in mammalian and bacterial expression systems, advanced analytical platforms including high-resolution mass spectrometry and next-generation sequencing, and a regulatory-focused approach that generates the data your IND submission requires. Whether you are developing a monoclonal antibody, an antibody-drug conjugate, a recombinant protein, or a cell or gene therapy, we provide the scientific depth and hands-on partnership to move your program forward.

Cell Line Development and Engineering

Develop and optimize your expression system using CRISPR-based gene editing, stable and transient expression platforms, and phenotypic and genotypic characterization — with master and working cell bank generation to support your clinical program.

Analytical Characterization and Method Qualification

Characterize your biologic with a full suite of analytical techniques, including identity and purity testing, cell-based and ligand-binding potency assays, protein sequence verification, PTM analysis, and method qualification to support your regulatory submissions.

Vector and Delivery System Evaluation

Support your cell and gene therapy program with viral vector QC and characterization, lipid nanoparticle and polymer-based delivery analytics, and gene editing efficiency and off-target analysis.

Pre-Formulation and Formulation Development

Develop robust, scalable formulations for your biologic through buffer optimization and excipient selection, solubility and aggregation studies, and compatibility testing designed to support manufacturability and shelf life.

Stability Testing

Establish your product’s storage conditions and shelf life with accelerated and real-time stability studies, ICH-compliant stability-indicating assays, and long-term storage condition optimization across temperature, pH, and freeze-thaw cycles.

Cell Banking and Repository Services

Establish and store qualified master and working cell banks with long-term cryogenic storage, full characterization documentation, and compound management services — helping ensure your biologics materials are secure, traceable, and accessible throughout development.