As part of our Pharmaceutical Development & Manufacturing organization, we operate a specialized department - Biosimilar Development. We provide end-to-end, research- and development-centric CMC services to design, develop, and characterize monoclonal antibody (mAb) biosimilars with phase-appropriate rigor and manufacturability in mind.
Overview of Monoclonal Antibody Biosimilars
Monoclonal antibody biosimilars are recombinant immunoglobulins intended to match a reference product's critical quality attributes (CQAs) within predefined ranges, thereby achieving highly similar structure, function, and performance under prescribed conditions. Their complexity arises from large molecular size, heterogeneous glycosylation, higher-order structure, charge variants, and micro-heterogeneities introduced during expression and purification. Establishing analytical similarity requires orthogonal, state-of-the-art methods spanning intact and subunit mass spectrometry, peptide mapping, glycan profiling, higher-order structure analytics, impurity characterization, and sensitive functional bioassays reflecting target binding and Fc-mediated effector functions (e.g., ADCC and CDC) as applicable. A robust CMC approach links the quality target product profile (QTPP) to process design so that biosimilar lots consistently express the desired attribute space with appropriate stability, ensuring reliable performance throughout development and commercialization pathways.
Our Services
Our services are built around analytical similarity, process understanding, and manufacturability—without drifting into discovery-stage activities. Below is an overview of our core service categories; each can be engaged as a standalone module or as a coordinated package.
Reference & CQA Mapping Service
We establish a CQA blueprint by extensively profiling multiple reference product lots. Using quantitative multi-attribute methods (MAM), intact/subunit MS, peptide mapping, released and site-specific glycan analysis, charge/hydrophobic variants, aggregation/particles, and higher-order structure, we define attribute criticality and similarity acceptance ranges. We then translate the blueprint into assay panels and process design targets, creating a living CQA map that guides all subsequent development.
Cell Line & Upstream Alignment Service
We generate biosimilar-ready production cell lines and upstream processes tuned to the CQA blueprint. Clone selection prioritizes glycan distribution, impurity background, and productivity compatible with downstream polishing. Fed-batch and perfusion prototypes are screened for glycosylation, charge profile, and fragmentation propensity. DoE-driven media/feed strategies control galactosylation, fucosylation, and sialylation as applicable, enabling attribute steering without compromising robustness.
Purification & Impurity Control Service
We develop platform-informed yet product-specific downstream trains—Protein A capture, low-pH viral inactivation, and orthogonal polishing (ion exchange, HIC, mixed-mode) tuned to reduce process-related impurities and align charge/glyco variants. Host cell protein (HCP) clearance is monitored via LC-MS and immunoassays; DNA and leachables are minimized through resin selection, cycling studies, and step qualification. The outcome is a purification strategy that reproducibly centers the biosimilar in the target attribute space.
Analytical Similarity & Bioassay Development Service
We configure a tiered similarity plan with sensitive, orthogonal analytics. Biophysical characterization covers DLS, AUC, SV-AUC as needed, DSC, FTIR/CD for higher-order structure, and stress-response fingerprints. Functional comparability uses binding kinetics (SPR/BLI) and qualified cell-based assays mirroring Fc and Fab mechanisms where relevant.
Formulation & Stability Engineering Service
We design formulations for both development and scale-up suitability, balancing colloidal/chemical stability with viscosity and process compatibility. Excipients are screened for oxidation/deamidation control, interfacial stress tolerance, and freeze–thaw resilience. Accelerated, stress, and long-term stability studies define degradation kinetics and attribute drift; data feed into a risk-based control strategy and support high-concentration presentations when needed.
Similarity Study Design & Data Package Service
We plan and execute analytical similarity studies across lots, sites, and scales, including statistical justification of acceptance ranges and predefined equivalence approaches. Comprehensive reports integrate CQA rationale, orthogonal assay concordance, and stability/forced-degradation concordance. The package is prepared to dovetail with subsequent phases of development and tech-transfer readiness, while staying firmly within the R&D and CMC scope.
Our Monoclonal Antibody Biosimilar Portfolio
We focus on widely adopted mAb formats and isotypes, ensuring that development aims remain conventional, reproducible, and aligned with platform knowledge. We provide development services, including—but not limited to—the following categories:
- IgG1 biosimilar development
- IgG2 biosimilar development
- …
- IgG4 biosimilar development
- Effector-modulated mAb development
We integrate reference profiling, CQA mapping, upstream/downstream alignment, orthogonal analytics, and formulation science into a coherent CMC pathway for monoclonal antibody biosimilars. Our phase-appropriate programs prioritize analytical similarity, manufacturability, and stability. We welcome collaboration to translate your biosimilar concept into a robust development package.
Our products and services are for research use only.
