CDMO Capabilities

ShilpaBio’s team of scientists has significant experience in contract research, development and manufacturing services.

Our research team comprises of experts in molecular biology, biochemistry, process characterization, scale-up activities, and fill-finish developments.

Our best-in-class drug substance/drug product development and manufacturing space, with R&D, analytical development, manufacturing, and quality control labs making us the right size to deliver on all of your project needs. Our expert team has vast experience to help you take your product from concept to commercialization. The Quality and Regulatory teams provide added support during the critical manufacturing processes.

CDMO Capabilities

Clone Development Capabilities

  • Microbial Host Systems: E. coli, Pichia pastoris, Saccharomyces cerevisiae, other microbial systems.
  • Mammalian Host Systems: CHO-S, CHO-K1 and CHO GS, HEK293, SF9, others as required.
  • Construct design and cloning into expression vectors
  • Transformation and Transfection
  • Screening clones for selecting high expression clones
  • Monoclonality confirmation
  • Clonal stability studies
  • Preparation of RCB (Research Cell Bank)

Upstream Process Development Capabilities

General Focus Areas

  • Media Optimization Studies:
    • Using Shake Flasks, Ambr® 15mL Bioreactors, and 2L/10L Fermenters.
    • Tailored for specific cell lines or microbial strains.
  • Scalable Fermentation Process Development:
    • Fed-batch, High-Density (HD) Fed-batch, and Continuous Perfusion for mammalian systems.
    • Batch, Fed-batch, and High-Density fermentation for microbial systems.
  • Scale-Down Studies:
    • Mimic large-scale performance at bench and pilot scale to refine process conditions.
    • Identify bottlenecks and develop titer improvement strategies.

Mammalian Cell Culture Capabilities

Platform and Scale:

  • Media Development:
    • Optimized chemically defined and animal component-free media.
    • Evaluation of feeds for enhanced growth and productivity.
  • Process Modes:
    • Fed-Batch: High titer production with fine-tuned feeding strategies.
    • Continuous Perfusion: Ideal for high-cell-density, long-term culture with constant product harvest.



  • Scalability:
    • Ambr® 15mL Micro Bioreactors for high-throughput screening.
    • 2L and 10L Glass Fermenters for process refinement.
    • 50L Single-Use Bioreactors (SUBs) for pilot-scale production.
    • Scaleup and commercial scale production using 1000L or 2000L SUBs
  • Applications:
    • Monoclonal antibodies
    • Fusion Proteins
    • Complex glycosylated proteins
    • Antibody Drug Conjugates
    • Bispecific Antibodies
    • Recombinant enzymes

Microbial Fermentation Capabilities

Platform and Scale

  • Media Development:
    • Customizable media for rapid growth and high expression.
    • Balance between biomass and product formation.
  • Process Modes:
    • Batch: Suitable for proof-of-concept and simple process needs.
    • Fed-Batch: For high yield and productivity.
    • High-Density Fermentation: Targeting ultra-high titres, especially for inclusion bodies and secretory proteins.

CDMO Capabilities
  • Scalability:
    • 5L Glass Bioreactors for initial development and optimization.
    • 20L SS Bioreactors for consistency batches.
    • 100L or 200L Pilot-Scale Bioreactors for scale-up.
    • 1000L Scale Bioreactors for process validation.
  • Applications:
    • Biosimilars
    • Recombinant proteins
    • Industrial enzymes

Downstream Process Development Capabilities

Platform and Scale

  • General Steps Involved in Purification of Proteins:
    • Harvesting
      • Centrifugation: To separate cells from the culture medium.
      • Filtration: To remove cells and debris, especially when the product is secreted into the culture medium.
      • Cell lysis: If the product is intracellular, using chemical, mechanical, or enzymatic methods.
    • Clarification
      • Centrifugation: Further centrifuging to remove large debris.
      • Microfiltration or Ultrafiltration: Use of semi-permeable membranes to separate particles based on size.
      • Depth filtration: Filters with larger pores are used to capture particulates and debris.
    • Protein Precipitation (if applicable)
      • Precipitation agents (like ammonium sulfate or polyethylene glycol) are often used to selectively precipitate proteins, which can then be separated via centrifugation.




  • Chromatographic Purification
    • Affinity Chromatography
    • Ion-Exchange Chromatography
    • Size-Exclusion Chromatography (SEC)
    • Reverse-Phase Chromatography
  • Concentration
    • Ultrafiltration
  • Polishing Steps
    • Chromatographic polishing
    • Nanofiltration or Reverse Osmosis
  • Formulation and Final Preparation
    • Buffer exchange: The purified product may be exchanged into a buffer that stabilizes the protein or product.
    • Lyophilization (freeze-drying): Often used for biologics and vaccines to increase shelf-life by turning the product into a dry, stable form.
    • Stabilization: The product may require the addition of stabilizers (e.g., sugars, salts, or excipients) to maintain stability during storage.

Analytical Support

General Focus Areas

  • Lot Release Method Development:
    • Identification of active ingredients, impurities, or contaminants.
    • Quantification of the drug substance or drug product – HPLC/UPLC-based titer estimation methods.
    • Purity assessment (e.g., assessing the presence of impurities, degradation products) – HPLC/UPLC – SEC, RP, IEX, Affinity; CE-based methods – CE SDS, CZE, cIEF.
    • Activity Assessment Methods – cell-based assays – proliferation, proliferation inhibition, apoptosis, cytotoxicity assays; ligand binding assays – ELISA, SPR.
    • Stability testing (e.g., determining the stability of formulations under various conditions).
  • Raw Materials, In-Process, Intermediates, Drug Substance, and Drug Product Testing:
  • Product Characterization Method Development:
    • Primary structure analysis by Mass Spectrometry-based methods – intact mass, peptide mapping, disulphide bridge analysis.
    • Higher Order Structure Analysis – Circular Dichroism, Intrinsic and Extrinsic Fluorescence Analysis, Structural changes in product by binding to specific ligands.
    • Impurity Characterization – charge variants, size variants, glycan variants, amino acid modifications.
    • Receptor binding assays - FcγRIa, FcγRIIa, FcγRIIIa, FcγRIb, FcγRIIb, FcγRIIIIb, C1q, FcRn.
  • Comparability Studies
  • Biosimilarity Studies
  • Forced Degradation Studies
  • Stability Studies
  • Method Optimization:
    • Developing a Robust Method: During optimization, the goal is to fine-tune the experimental conditions to achieve the best performance for accuracy, precision, sensitivity, and reproducibility. This step includes:
      • Sample Preparation: Ensuring that the sample is prepared in a way that minimizes interferences and maximizes analyte concentration, including dissolution, extraction, or dilution.
      • Optimization of Instrument Parameters: Adjusting key parameters such as mobile phase composition, column selection, flow rate, temperature, wavelength, etc.
      • Validation of Specificity: Ensuring the method can accurately distinguish the target analyte from potential interferences.
      • Sensitivity and Detection Limits: Ensuring that the method can detect trace amounts of the analyte of interest.
  • Validation of Analytical Methods:
    • Validation parameters typically include:
      • Accuracy: The degree to which the measured value matches the true value or a reference standard.
      • Precision: The degree of agreement between repeated measurements under identical conditions (repeatability and intermediate precision).
      • Specificity: The ability to measure the analyte without interference from other components in the sample (e.g., impurities, degradation products).
      • Linearity: The ability of the method to produce results that are directly proportional to the concentration of analyte within a given range.
      • Range: The interval between the upper and lower concentrations of analyte that can be reliably measured.
      • Limit of Detection (LOD): The smallest concentration of the analyte that can be detected but not necessarily quantified.
      • Limit of Quantification (LOQ): The smallest concentration of the analyte that can be reliably quantified with acceptable accuracy and precision.
      • Robustness: The ability of the method to remain unaffected by small, deliberate changes in experimental conditions (e.g., temperature, pH, column type).
      • System Suitability: Ensuring the analytical system performs adequately before and during analysis (e.g., checking chromatographic system performance in HPLC).