Antibody Biosimilar Development

Comprehensive capabilities from CHO cell line development through regulatory strategy for clinical waiver in semi-regulated and regulated markets.

Capabilities & Instrumentation

Explore our end-to-end infrastructure for biosimilar characterization and development

01 CHO Cell Line Development

Capabilities

Vector design & transfection
Stable clone selection
Clone screening & productivity ranking
Genetic stability assessment
Cell banking (MCB/WCB support)

Instrumentation

Electroporation systems Clone screening platforms Automated cell counters Flow cytometer Incubators (CO₂ controlled) Controlled-rate freezers Bioreactor systems (Ambr / bench-scale)

02 Upstream Process Development

Capabilities

Media optimization
Feed strategy development
DoE-based process optimization
Scale-down models
Perfusion modeling

Instrumentation

Benchtop bioreactors (2L-10L) Ambr micro-bioreactor systems Bioprocess analyzers (glucose, lactate) pH/DO monitoring systems Cell viability analyzers

03 Downstream Process Development

Capabilities

Protein A purification
Ion exchange chromatography
Hydrophobic interaction chromatography
Ultrafiltration / Diafiltration
Viral clearance model studies (collaborative)

Instrumentation

AKTA purification systems Chromatography columns TFF systems SEC-HPLC Fraction collectors

04 Analytical & Bioanalytical Characterization

Capabilities

Intact mass analysis
Peptide mapping
Glycosylation profiling
Charge variants (cIEF)
Aggregation (SEC-MALS)
Thermal stability (DSC)
Binding affinity (SPR / BLI)
ADCC / CDC assays
Fc receptor binding
Potency bioassays
PK bioanalysis
ADA assay development support
Aggregation-related immunogenicity risk profiling

Instrumentation

LC-MS/MS (HRMS) SPR (Biacore equivalent) Octet/BLI cIEF system DSC SEC-MALS Flow cytometry ELISA readers Cell culture biosafety cabinets Real-time PCR Stability chambers

05 Regulatory Strategy for Clinical Waiver

Capabilities

Analytical similarity strategy design for semi-regulated and regulated markets
Reference product selection strategy
Statistical similarity assessment (equivalence / quality range approach)
Totality-of-Evidence dossier building
Clinical waiver justification based on analytical and functional similarity
CMC module preparation (Module 3)
Gap analysis for regulatory submission
Pre-submission consultation support

Instrumentation

Statistical analysis platforms Regulatory intelligence databases Documentation management systems

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Contact the ICT Mumbai Nanomedicine Research Group for collaboration, bioanalytical support, or characterization services.

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