Marin Biologic Laboratories, Inc.

Preclinical ADME/Tox studies and PK/PD assays to characterize exposure, clearance and toxicological profiles supporting regulatory submissions.

Binding/internalization, payload release, nanoparticle sizing, stability and biodistribution assays for nanoparticle and LNP formulations.

Protein expression, gel-based imaging, Western blot, binding assays and related protein analytics to support functional and potency testing.

Stability study design and analytical testing to define shelf-life and potency retention with regulatory-aligned reporting.

Generation, characterization and GMP production of stable cell lines and Master Cell Banks to support assays and manufacturing.

Project and data management to transition assays from discovery through validation to regulated release and commercialization.

Integrated in vitro and cell-based assays for ADC discovery and development including internalization, cytotoxicity, ADCC/ADCP, potency, immunogenicity (ADA/NAb) and stability-linked potency testing.

Comprehensive T-cell assay portfolio including cytotoxicity, activation, proliferation, cytokine secretion and co-culture killing assays for immunotherapy development.

Biodistribution and efficacy studies to evaluate intranasal delivery strategies and olfactory-epithelium targeting in animal models, including assessment of microbial vector approaches.

In vitro and in vivo assays to assess effects of probiotic strains and microbial metabolites on immune cell populations, cytokine production and autophagy-linked mechanisms.

Assay and screening support for mutant capsid libraries, including in vitro selection and in vivo screening strategies to identify capsids with altered tropism or antibody evasion.

Molecular biology support including viral vector and plasmid construction (research and small-scale GMP), vector genome and infectious titer assays, and residual host DNA/protein quantitation.

Preparation of regulatory-aligned assay documentation and direct liaison with regulatory authorities to support IND submissions, lot release and stability approval pathways.