- Protein Characterization & Analytical Services
Simplifying the Answers You Seek
- Diagnostics
- Laboratory
- Health
- Care
- Overview
Protein Characterization & Analytical Services
At Mano- tri, we specialize in comprehensive protein characterization and bioanalytical testing to support biotherapeutic, biosimilar, and molecular biology research. Our advanced analytical platforms enable precise evaluation of protein structure, purity, potency, and stability, critical for regulatory filings, IND support, and biosimilar development.
Core Capabilities
- Protein Characterization: Detailed analysis of physicochemical properties, structural confirmation, and impurity profiling through advanced analytical and biological assays.
- Bioanalytical Testing: Custom assay development using cell-based, binding, and in-vivo assays for potency determination and bioassay validation as per ICH Q2(R1) and pharmacopeial guidelines.
- GMP-Compliant Quality Control:End-to-end QC testing from raw materials to final product, including microbiological, environmental, and stability testing, aligned with global GMP standards.
Analytical & Molecular Biology Services
Our bioanalytical laboratory services are equipped with state-of-the-art instruments for precision testing and method development.
Core Capabilities:
- Analytical method development, transfer, and validation
- HPLC / UPLC assays for purity, related substances, and charge variants
- Protein quantitation and aggregate analysis (SEC, DLS)
- Glycoform profiling – monosaccharide composition, glycan mapping, LC-MS/MS
- Electrophoretic techniques – SDS-PAGE, capillary electrophoresis, imaged CE
- Peptide mass fingerprinting and amino acid sequencing
- Immunological assays – ELISA, Western blot, and flow cytometry
GMP Manufacturing Infrastructure
Our state-of-the-art GMP facility ensures seamless transition from R&D to clinical-grade production.
Facility Highlights:
- Independent microbial & mammalian suites with controlled upstream/downstream operations
- Automated Delta-V system for process monitoring and cleaning
- Bioreactors ranging from 100L to 2000L, including disposable bioreactor systems
- Stability chambers (-70°C to +40°C), photostability testing, and TOC analysis
Biosimilar Development & Characterization
Our biosimilar development services integrate cell line development, process optimization, and comprehensive biosimilarity assessment to accelerate product readiness for regulated markets.
Key Offerings:
- Basic & advanced biosimilarity characterization packages
- Drug substance and product process development
- Method validation for regulatory submissions
- Comparative analytical and functional studies
Advanced Instrumentation
Our analytical lab features advanced technologies including:
MALDI-TOF/TOF, LC-ESI-MS/MS, Biacore, Flow Cytometry, Maurice (cIEF), HIAC, PAMAS, and Karl Fischer titration systems for comprehensive protein and impurity analysis.
- Why Partner With Us
Complete Characterization Under One Roof
High-End Analytical Infrastructure
True GMP Compliance at Every Step
Strong Biosimilar Characterization Expertise
Integrated Molecular Biology & Bioanalytical Strength
Frequently Asked Quesions
We offer a wide range of bioanalytical laboratory services, including HPLC/UPLC tests, SEC, DLS, glycoform profiling, ELISA, Western blotting, flow cytometry, and peptide mass fingerprinting. These skills aid in biologics development, biosimilarity assessment, and regulatory submissions for companies involved in Biosimilar Manufacturing and Biosimilar Products.
Yes. Our Analytical & Molecular Biology team specializes in Analytical Method Development Services, method transfer, and validation in accordance with ICH Q2(R1) standards. This is critical for biopharma, biosimilar manufacturers in India, and worldwide CDMO companies preparing for IND, NDA, and biosimilar filings.
Absolutely. We provide comprehensive biosimilarity assessments, ranging from cell line development to functional biosimilarity tests, making us a reliable partner for India’s top biosimilar companies. Our integrated workflows enable the analytical, functional, and structural comparisons required for authorized biosimilar pathways.
Yes. Our facility provides completely aligned GMP Pharmaceutical Manufacturing QC testing, which includes microbiological analysis, impurity profiling, stability studies, and in-process quality control. Our microbial and mammalian suites also enable large-scale upstream/downstream development for Microbial Fermentation Manufacturing and Bacterial Fermentation Process applications.
Yes. Along with protein characterization, we offer analytical support for peptide and nucleotide programs via Peptide Synthesis Service, Solid Phase Peptide Synthesis, Oligonucleotide Synthesis, and Custom Oligonucleotide Synthesis. These services supplement our bioanalytical expertise in hybrid biologics, vaccines, and nucleic acid therapies.
- Contact Us