Marin Biologic Laboratories, Inc.
MarinBio is a Contract Research Organization (CRO) with over 30 years of scientific expertise, specializing in drug discovery, development services, assay solutions, and gene therapy research. They focus on innovative scientific services including cell-based assays, pharmacokinetics, gene therapy, immunotherapy, and antibody development, supporting clients in advancing therapeutic drugs, gene therapies, and biologics. MarinBio is committed to transforming drug development and providing tailored scientific solutions to meet the needs of the biopharmaceutical industry, with a strong emphasis on assay development, validation, and regulatory support.
Industries
Nr. of Employees
small (1-50)
Marin Biologic Laboratories, Inc.
Products
Cell-Based
Contract research and development services specializing in customized or standardized cell-based bioassays, including method development, qualification, validation, lot release, and potency testing for pharmaceutical and biopharmaceutical products.
Cell-Based Assay Development & GMP Validation
Comprehensive bioanalytical services for designing, developing, and validating GMP cell-based assays to quantify biological processes and evaluate cellular responses.
Cell-Based Assays & Bioanalytical Services
Affordable, reliable, and fast cell-based assays and bioanalytical services including GMP-compliant testing and BLA-ready potency assays.
Flow Cytometry
Advanced flow cytometry services equipped with 4 lasers and 14-color detection capabilities for cell phenotyping, signaling pathways, cell health, metabolism, and single-cell sorting.
Flow Cytometry-Based AAV Potency Assay
Flow cytometry assay service utilizing HEK293 cells transduced with mCherry-encoding AAV to gate live cells and analyze transgene expression.
Immunotherapy Assay Services
Customized R&D, pre-clinical and clinical assay services for immunotherapy development including cell-based assays, potency assays, stability testing, and lot release testing.
Cell-Based
Contract research and development services specializing in customized or standardized cell-based bioassays, including method development, qualification, validation, lot release, and potency testing for pharmaceutical and biopharmaceutical products.
Cell-Based Assay Development & GMP Validation
Comprehensive bioanalytical services for designing, developing, and validating GMP cell-based assays to quantify biological processes and evaluate cellular responses.
Cell-Based Assays & Bioanalytical Services
Affordable, reliable, and fast cell-based assays and bioanalytical services including GMP-compliant testing and BLA-ready potency assays.
Flow Cytometry
Advanced flow cytometry services equipped with 4 lasers and 14-color detection capabilities for cell phenotyping, signaling pathways, cell health, metabolism, and single-cell sorting.
Flow Cytometry-Based AAV Potency Assay
Flow cytometry assay service utilizing HEK293 cells transduced with mCherry-encoding AAV to gate live cells and analyze transgene expression.
Immunotherapy Assay Services
Customized R&D, pre-clinical and clinical assay services for immunotherapy development including cell-based assays, potency assays, stability testing, and lot release testing.
Services
Design, optimization and validation of cell-based bioassays for potency, proliferation, cytotoxicity and functional readouts under GLP/GMP for IND/BLA support and lot release.
GMP/GLP-compliant potency assays and lot-release testing including reference standard development and stability-linked potency assessment.
Custom cell-based potency assays, pharmacokinetic ligand-binding ELISAs and preclinical PK/PD assay development for viral vectors, including transduction-inhibition and reporter assays.
Mechanism-of-action and potency assays for degraders including ternary-complex, ubiquitination and cellular degradation readouts.
Ligand-binding assays, kinetic binding analysis and protein characterization supporting PK, biodistribution and potency measurement.
Multiparametric flow cytometry for phenotyping, functional assays, ADCC/ADCP and immunogenicity testing, and infectious titer measurement.
Design, optimization and validation of cell-based bioassays for potency, proliferation, cytotoxicity and functional readouts under GLP/GMP for IND/BLA support and lot release.
GMP/GLP-compliant potency assays and lot-release testing including reference standard development and stability-linked potency assessment.
Custom cell-based potency assays, pharmacokinetic ligand-binding ELISAs and preclinical PK/PD assay development for viral vectors, including transduction-inhibition and reporter assays.
Mechanism-of-action and potency assays for degraders including ternary-complex, ubiquitination and cellular degradation readouts.
Ligand-binding assays, kinetic binding analysis and protein characterization supporting PK, biodistribution and potency measurement.
Multiparametric flow cytometry for phenotyping, functional assays, ADCC/ADCP and immunogenicity testing, and infectious titer measurement.
Expertise Areas
- Cell-based assay development and GLP/GMP validation
- Potency and lot-release testing for biologics and cell/gene therapies
- Gene therapy assay development and viral vector analytics
- Immunoassay development and protein biophysical characterization
Key Technologies
- Cell-based potency and reporter assays
- Enzyme-linked immunosorbent assay (ELISA) and ligand-binding assays
- Quantitative PCR (qPCR) and vector genome titer assays
- Multiparametric flow cytometry and single-cell analysis
News & Updates
FDA Inspection Success 2025
MarinBio successfully passed FDA inspection in 2025 with no 483s or observations.
Published a white paper on strategies for drug potency assurance and assay development.
Recent Blogs and Articles on Assay Development and Gene Therapy
Various blogs and articles on assay validation, gene therapy, and drug development.
Discusses the importance of potency assays in CAR T-cell therapy development.
Strategies for high throughput screening using cell-based assays.
Guidelines for designing and validating GMP-compliant cell-based potency assays.
FDA Inspection Success 2025
MarinBio successfully passed FDA inspection in 2025 with no 483s or observations.
Published a white paper on strategies for drug potency assurance and assay development.
Recent Blogs and Articles on Assay Development and Gene Therapy
Various blogs and articles on assay validation, gene therapy, and drug development.
Discusses the importance of potency assays in CAR T-cell therapy development.
Strategies for high throughput screening using cell-based assays.
Guidelines for designing and validating GMP-compliant cell-based potency assays.