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Bioanalytical Laboratory Services
At Mano-Tri Pharma, our GLP-certified and GMP-compliant Bioanalytical Laboratory provides end-to-end analytical support for evaluating pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of biologics and vaccines. Equipped with advanced instrumentation and managed by highly trained scientists, we deliver precise, reliable data that accelerates drug discovery and development.
Our expertise spans monoclonal antibodies, recombinant proteins, enzymes, cytokines, biomarkers, vaccines, and hormones : supporting both preclinical and clinical development phases with global regulatory alignment.
Analytical Infrastructure
Our Molecular Biology Laboratory and Bioanalytical facility are equipped with advanced instruments supporting a wide range of assays and analytical technologies:
- Cell-based, fluorescence, luminescence, and electrochemiluminescence assays
- Meso Scale Discovery (Sector Imager 2400/6000) systems
- ELISA readers and washers, spectrophotometers (Synergy, Spectramax, Infinite series)
- Surface Plasmon Resonance (Biacore T-100) for high-resolution binding kinetics
- Automated liquid handling systems (Tecan Genesis and Freedom Evo platforms)
- Ultra-low temperature storage systems with real-time monitoring and alarms
Core Capabilities
- Method development, validation, and transfer for ligand-binding assays
- Sample analysis using ELISA, MSD, and both cell-based and non-cell-based assays
- Statistical analysis, data management, and comprehensive report generation
- Secure sample storage and bioanalytical data archival
- Why Partner With Us
Dedicated project teams specialized in PK/PD and immunogenicity studies
Personnel trained under GLP/GCLP and GMP pharmaceutical manufacturing standards
21 CFR Part 11–compliant systems ensuring data integrity and traceability
Integrated Watson LIMS™ and Electronic Lab Notebook (ELN) for seamless data capture and workflow tracking
Proven global logistics with zero sample compromise and rapid custom clearance
Frequently Asked Quesions
Our Bioanalytical Laboratory Services adhere to GLP and GMP standards, including proven ligand-binding assays, cell-based functional assays, ELISA, MSD platforms, and Biacore SPR for binding kinetics. These capabilities provide precise PK/PD profiling and immunogenicity assessment for biologics, vaccines, monoclonal antibodies, and biosimilar medicines.
Yes. We provide comprehensive Analytical Method creation Services, which include method creation, validation, transfer, and statistical analysis. Our systems are compliant with 21 CFR Part 11 and align with worldwide standards, making them perfect for biologics and biosimilar manufacturing pipelines.
Absolutely. Our Molecular Biology Services and Bioanalytical Lab collaborate to support recombinant protein analysis, cell-based assays, gene expression research, and sample characterisation for IND-enabling investigations. This integrated workflow increases efficiency for CDMOs and CDMO Companies in India.
Yes. Our facility conducts complete PK/PD, immunogenicity, and binding kinetics assessments for antibody candidates, assisting developers and monoclonal antibody manufacturers. We also provide support for early research initiatives through the Monoclonal Antibody Development Service.
Yes. We frequently test samples for biosimilar products, recombinant proteins, enzymes, and microbial therapies associated with Microbial Fermentation Services and the Bacterial Fermentation Process. Our verified methods provide data quality for businesses, including the Top Biosimilar Companies in India and Biosimilar Manufacturers in India.
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