Mass Spectrometry (LC-MS/MS)
Intact and reduced molecular weight determination, primary amino acid sequence verification, peptide mapping, disulfide bond mapping and identification of post-translational modifications (PTMs).
cGMP analytical testing laboratory delivering structural characterization, bioassays and ICH stability studies for complex biologics.
Demonstrating safety, purity, potency and batch-to-batch comparability requires an advanced analytical testing laboratory equipped with high-resolution instrumentation and deep bioprocessing expertise. At Shilpa Biologicals, our biologics analytical testing services provide complete analytical lifecycle management for monoclonal antibodies (mAbs), fusion proteins, recombinant enzymes, biosimilars and microbial biopharmaceuticals. Operating out of our cGMP facility in Dharwad, Karnataka, India, our quality control and analytical development teams derisk drug development programs through strict adherence to ICH, USFDA, EMA and CDSCO regulatory frameworks.
Integrated Analytical & Stability Lifecycle
Accurate structural characterization is essential for establishing Critical Quality Attributes (CQAs) and proving similarity during biosimilar candidate development:
Intact and reduced molecular weight determination, primary amino acid sequence verification, peptide mapping, disulfide bond mapping and identification of post-translational modifications (PTMs).
High-resolution N-linked and O-linked oligosaccharide analysis using UHPLC-FLR-MS to evaluate sialylation, fucosylation and galactosylation patterns affecting effector function and half-life.
Secondary and tertiary conformational analysis utilizing Circular Dichroism (CD), Differential Scanning Calorimetry (DSC) and Fourier Transform Infrared Spectroscopy (FTIR).
Controlling product-related variants and degradation pathways ensures batch consistency:
Quantitative assessment of charge variants (acidic and basic species) resulting from deamidation, C-terminal lysine clipping, or sialylation.
Multi-Angle Light Scattering coupled with Size Exclusion Chromatography (SEC-MALS) and Dynamic Light Scattering (DLS) to quantify soluble aggregates, high molecular weight species (HMWS) and low molecular weight fragments (LMWS).
Capillary Electrophoresis SDS under reducing and non-reducing conditions to detect fragmentation, non-covalent association and purity percentages.
Confirming biological activity is mandatory for lot release and comparability studies:
Custom-designed cell proliferation, cytotoxicity (ADCC/CDC), apoptosis and reporter-gene assays conducted within cleanroom cell culture suites.
Label-free kinetic binding analysis (kon, koff, KD) evaluating target antigen binding, FcRn affinity for half-life assessment and Fc gamma RIIIa receptor binding for effector activity.
Multi-mode reader-based ELISAs for binding quantification, residual host cell protein (HCP) detection and protein A leaching assays.
Shilpa Biologicals provides comprehensive analytical characterization and ICH stability testing backed by 21 CFR Part 11 compliant systems.
Establishing shelf-life and degradation pathways requires a dedicated stability testing laboratory operating under strict environmental controls. As a leading biopharma stability testing laboratory, Shilpa Biologicals provides ICH Q1A(R2) compliant stability study programs across all global climate zones.
| Stability Program Type | Environmental Storage Condition | Standard Testing Intervals | Primary Study Objective |
|---|---|---|---|
| Real-Time / Long-Term | Environmental Storage Condition2 to 8°C (Refrigerated) 25°C ± 2°C / 60% RH ± 5% |
Standard Testing Intervals0, 3, 6, 9, 12, 18, 24, 36 Months | Primary Study ObjectiveDefining official shelf-life and expiry under recommended storage conditions. |
| Intermediate Stability | Environmental Storage Condition30°C ± 2°C / 65% RH ± 5% | Standard Testing Intervals0, 3, 6, 9, 12 Months | Primary Study ObjectiveEvaluating potential excursions outside standard cold-chain parameters. |
| Accelerated Stability | Environmental Storage Condition40°C ± 2°C / 75% RH ± 5% | Standard Testing Intervals0, 1, 2, 3, 6 Months | Primary Study ObjectiveAccelerating chemical degradation to predict long-term stability trends. |
| Frozen Storage | Environmental Storage Condition-20°C ± 5°C / -80°C ± 10°C | Standard Testing Intervals0, 1, 3, 6, 12, 24 Months | Primary Study ObjectiveSupporting bulk drug substance (DS) long-term intermediate storage stability. |
| Forced Degradation | Environmental Storage ConditionStress (Heat, Light, Acid/Base, Oxidation, Shear) | Standard Testing IntervalsCustom short-term time points | Primary Study ObjectiveIdentifying degradation pathways and proving method stability indication. |
Protecting drug product integrity across retail and clinical supply chains:
Exposure testing using calibrated UV and visible light chambers to evaluate light sensitivity in primary container closure systems.
High-voltage leak detection (HVLD), dye ingress and head-space gas analysis ensuring container sterile barrier maintenance over shelf-life.
Evaluating mechanical stability during transport simulation and freeze-thaw cycle robustness for bulk drug substance.
Whether transferring an existing analytical method or developing a novel assay from scratch, Shilpa Biologicals executes structured, compliant workflows. Our team serves as an expert stability studies biologics CDMO and analytical partner across all phase-appropriate qualification stages.
| Method Parameter | Target Acceptance Criteria | Operational Relevance |
|---|---|---|
| Specificity / Selectivity | Target Acceptance CriteriaNo matrix interference at target retention time. | Operational RelevanceGuarantees accurate analyte identification amidst complex excipients. |
| Linearity & Range | Target Acceptance CriteriaR² ≥ 0.99 across 50% to 150% assay range. | Operational RelevanceConfirms direct proportionality between signal response and sample concentration. |
| Precision (Repeatability) | Target Acceptance Criteria% RSD ≤ 2.0% across replicate injections. | Operational RelevanceDemonstrates internal method consistency under identical operating conditions. |
| Intermediate Precision | Target Acceptance Criteria% RSD ≤ 3.0% across different days/analysts. | Operational RelevanceEnsures robust inter-lab reproducibility and seamless transfer. |
| Accuracy / Recovery | Target Acceptance CriteriaMean recovery 98.0% to 102.0% across spikes. | Operational RelevanceValidates agreement between measured values and known true values. |
| LOD & LOQ Determination | Target Acceptance CriteriaSignal-to-Noise (S/N) ratio ≥ 3:1 (LOD) and 10:1 (LOQ). | Operational RelevanceEstablishes sensitive limits for trace impurity and degradant quantification. |
As a premier provider of biologics QC testing CDMO India services, we handle routine release testing for clinical and commercial batches:
Complete panel execution including appearance, pH, osmolality, content/potency, purity, endotoxin (LAL), sterility and particulate matter.
Head-to-head structural, functional and stability comparability testing demonstrating biosimilarity against global reference products (USFDA/EMA sourced).
Our centralized analytical testing laboratory in Dharwad houses high-resolution analytical platforms supported by continuous environmental monitoring and dual-redundancy power systems:
Central QC & Analytical Infrastructure
| Chromatographic & Electrophoretic Suite | High-throughput UPLC/HPLC systems with UV-Vis, Fluorescence and Refractive Index detectors; icIEF capillary electrophoresis systems; preparative HPLC for impurity isolation. |
| Mass Spectrometry Infrastructure | High-resolution mass spectrometers configured for intact protein analysis, peptide mapping and trace impurity identification. |
| Biophysical & Spectroscopy Lab | Differential Scanning Calorimeters (DSC), Circular Dichroism (CD) spectropolarimeters, Dynamic Light Scattering (DLS) units and Micro-Osmometers. |
| Microbiology & Safety Suite | Dedicated cleanrooms for sterility testing isolators, walk-in BOD incubators, automated kinetic LAL endotoxin readers and mycoplasma testing facilities. |
| cGMP Stability Walk-In Chambers | Walk-in stability rooms configured for -80°C, -20°C, 2 to 8°C, 25°C / 60% RH, 30°C / 65% RH and 40°C / 75% RH with automated 24/7 temperature/humidity data logging. |
Shilpa Biologicals operates state-of-the-art analytical testing laboratories governed by an integrated Quality Management System (QMS). Our infrastructure operates under strict CDSCO regulations, holds WHO-GMP certification and is engineered to maintain compliance with USFDA, EMA, ANVISA and PIC/S standards.
All analytical software platforms, chromatographic data systems (CDS) and stability logging software feature audit trails, multi-level access controls and electronic signature capabilities.
Complete generation of Module 3 Quality (3.2.S and 3.2.P) CTD sections for global IND, NDA and BLA regulatory submissions.
Protocol-driven characterization, qualification, re-qualification and storage of primary and working reference standards.
Shilpa Biologicals provides an analytical and stability testing platform supporting biologics from early characterization through commercial batch release. Featuring high-resolution LC-MS/MS, icIEF, cell-based bioassays and walk-in cGMP stability chambers within an integrated 44,000 sqm campus, we deliver rapid turnaround and method validation. Headquartered in Dharwad, India, we serve biopharmaceutical partners globally, backing our operations with WHO-GMP certification and USFDA/EMA compliance alignment to derisk regulatory pathways.
Our analytical laboratory handles monoclonal antibodies (mAbs), fusion proteins, antibody-drug conjugates (ADCs), biosimilars, recombinant enzymes, cytokines and microbial biopharmaceuticals.
Yes, Shilpa Biologicals provides both standalone analytical method development/validation services and fully integrated analytical support tied to our biomanufacturing programs.
We maintain cGMP walk-in stability chambers covering real-time (2 to 8°C), intermediate (30°C / 65% RH), accelerated (40°C / 75% RH), frozen (-20°C, -80°C) and ICH Q1B photostability conditions.
Yes, all instrument software, data acquisition networks and stability monitoring platforms strictly comply with 21 CFR Part 11 regulations regarding data integrity and audit trails.
Yes, we conduct structural, physico-chemical, functional bioassay and stability comparability studies demonstrating biosimilarity against USFDA- and EMA-approved reference products.
Accelerate your biologic drug development with an experienced CDMO partner. From detailed structural characterization to ICH stability studies, our team delivers high-precision analytical data.
Shilpa Biologicals operates an advanced analytical testing laboratory and dedicated biopharma stability testing laboratory in Dharwad, India, delivering comprehensive biologics analytical testing services to pharmaceutical and biotechnology companies worldwide. Our centralized analytical infrastructure provides complete analytical lifecycle management including structural characterization, purity profiling, cell-based potency bioassays, ICH-compliant stability studies and cGMP QC batch release testing for monoclonal antibodies, biosimilars, fusion proteins, ADCs, recombinant enzymes and microbial biopharmaceuticals. As an integrated stability studies biologics CDMO, Shilpa Biologicals serves partners across the United States, European Union, Canada, Brazil, Japan and other regulated markets with the analytical depth, regulatory alignment and instrumentation infrastructure that global regulatory submissions demand.
A biologics analytical testing laboratory is a specialized facility equipped with high-resolution instrumentation and bioanalytical expertise to characterize, quantify and confirm the quality, safety, potency and stability of complex biopharmaceutical drug substances and drug products. An advanced analytical testing laboratory for biologics performs structural analysis using mass spectrometry, glycan profiling, charge heterogeneity testing, size variant analysis, cell-based bioassays and binding kinetics studies, while a stability testing laboratory executes long-term, accelerated and stress stability programs under ICH Q1A(R2) guidelines to establish shelf-life and degradation pathways. Shilpa Biologicals operates as a biologics QC testing CDMO in India, providing these specialized analytical and stability capabilities both as standalone services and as part of fully integrated biomanufacturing programs.
India has established itself as a strategic destination for biologics analytical testing services and stability studies outsourcing. International pharmaceutical companies increasingly partner with Indian analytical CDMOs for the following reasons:
Shilpa Biologicals is a subsidiary of Shilpa Medicare Limited, a publicly listed pharmaceutical company with over three decades of proven success in drug development, regulatory approvals and global supply across 50+ countries. This parentage provides Shilpa Biologicals with access to established quality management systems, deep regulatory expertise and robust operational infrastructure that underpin every analytical and stability testing engagement. As the dedicated biologics arm of the Shilpa group, Shilpa Biologicals brings this legacy of pharmaceutical excellence to the biologics analytical testing space, combining heritage and innovation to serve global CDMO partners.
Shilpa Biologicals operates a centralized analytical testing laboratory and biopharma stability testing laboratory within its 44,000 sqm biomanufacturing campus in Dharwad, India. Core capabilities include:
Shilpa Biologicals operates under an integrated Quality Management System (QMS) designed to meet the highest international regulatory standards for biologics analytical testing and stability studies. Our analytical testing laboratory maintains the following certifications and compliance alignments:
Regulatory affairs teams at Shilpa Biologicals generate complete Module 3 Quality CTD sections (3.2.S and 3.2.P) for global IND, NDA and BLA submissions, helping partners navigate regulatory pathways across the US, EU, Brazil, Japan and other target markets.
For pharmaceutical and biotechnology companies seeking a reliable analytical testing partner in India with high-resolution instrumentation, ICH-compliant stability infrastructure and global regulatory alignment, Shilpa Biologicals delivers the analytical depth, data integrity standards and integrated CDMO advantage required to advance biologics programs from early characterization through commercial QC release. Whether the requirement is standalone biologics analytical testing services, dedicated stability studies or fully integrated biologics QC testing as part of a CDMO engagement, our advanced analytical testing laboratory in India is engineered to support your regulatory and commercial objectives. Contact Shilpa Biologicals to discuss your analytical and stability testing requirements.