Services Peptide & Protein biosimilars Antibody Biosimilar Team Contact

R&D-driven manufacturing delivered globally

Scaling complex biosimilar development through deep chemical expertise, integrated software, and high-precision manufacturing capacity.

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Service Domains

How we can help you

We provide comprehensive end-to-end solutions for biosimilar development, from analytical characterization to process optimization and regulatory support. Our services include:

Monoclonal Antibody (mAb) Biosimilars

End-to-End Bioprocess & Characterization

Regulatory Framework

Regulatory mAb guidelines · ICH Q5E (Comparability) · ICH Q6B · Quality Considerations · Totality-of-Evidence framework

A. CHO Cell Line Development
  • Vector design & transfection
  • Stable clone selection
  • Clone screening & productivity ranking
  • Genetic stability assessment
  • Cell banking (MCB/WCB support)
Electroporation systems Clone screening platforms Automated cell counters Flow cytometer Incubators (CO₂ controlled) Controlled-rate freezers Bioreactor systems (Ambr / bench-scale)
B. Upstream Process Development
  • Media optimization
  • Feed strategy development
  • DoE-based process optimization
  • Scale-down models
  • Perfusion modeling
Benchtop bioreactors (2L-10L) Ambr micro-bioreactor systems Bioprocess analyzers (glucose, lactate) pH/DO monitoring systems Cell viability analyzers
C. Downstream Process Development
  • Protein A purification
  • Ion exchange chromatography
  • Hydrophobic interaction chromatography
  • Ultrafiltration / Diafiltration
  • Viral clearance model studies (collaborative)
AKTA purification systems Chromatography columns TFF systems SEC-HPLC Fraction collectors
D. Analytical & Bioanalytical Characterization (mAbs)
  • 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
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
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Peptide & Protein biosimilars

Analytical & Bioanalytical Services

Regulatory Framework

Regulatory Biosimilar Guidance (351(k)) · ICH Q6B · Scientific Considerations in Demonstrating Biosimilarity · Peptide sameness evaluation principles

Peptide Sameness & Structural Characterization
  • Primary structure confirmation
  • Amino acid sequencing
  • Mass accuracy determination
  • Disulfide bond mapping
  • Impurity profiling
UPLC-MS/MS Orbitrap HRMS Amino acid analyzers Peptide sequencers
Higher Order Structure (HOS) Analysis
  • Circular Dichroism (CD) spectroscopy
  • Fourier-Transform Infrared (FTIR) spectroscopy
  • Nuclear Magnetic Resonance (NMR) spectroscopy
  • X-ray crystallography support
  • Thermal shift assays
CD spectropolarimeter FTIR spectrometer NMR spectrometer DSC DSF
Bioanalytical & Functional Characterization
  • Receptor binding assays
  • Cell-based potency assays
  • Enzyme activity assays
  • Immunogenicity risk assessment
  • PK/PD studies
Instrumentation
SPR (Biacore equivalent) BLI (Octet) Flow cytometers ELISA readers Cell culture facilities
Formulation & Stability Studies
  • Pre-formulation screening
  • Excipient compatibility studies
  • Forced degradation studies
  • Accelerated stability studies
  • Real-time stability studies
Stability chambers (ICH conditions) HPLC systems UPLC systems LC-MS/MS UV-Vis spectrometers
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Our Team

Meet Our Experts

Our team combines decades of experience in biosimilar development, regulatory strategy, and analytical characterization. We are committed to delivering high-quality, cost-effective solutions tailored to your needs.

Ms. Akanksha Sail

Ms. Akanksha Sail

Business Development and Finance

Dr. Dhruv Soni

Dr. Dhruvkumar Soni

Project Manager

Dr. Aswani Kancherla

Dr. Aswani Kancherla

Group Leader: Biophysics

Dr. Giriraj Acharya

Dr. Giriraj Acharya

Head-Analytical Science & Partnerships

Ms. Nikita Jambhale

Ms. Nikita Jambhale

Senior Lead- Quality & Lab Operations

Mr. Aditya Achar

Mr. Aditya Achar

Lead-Analytical Science & Partnerships

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Partner with Us for Your Biosimilar Development Needs

Whether you're developing a new biosimilar or optimizing an existing process, our team is ready to support you with world-class expertise and state-of-the-art facilities.

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