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.

  • Development of transient and stable cell lines
  • Development and qualification of analytical methods for complete characterisation of proteins
  • Invitro Bioassay development, qualification
  • Characterisation of RCB and protein generated at small scale.
  • Development and qualification (and validation where needed) of in-process and lot release methods for process / product.
  • Media optimisation studies in shakeflasks, AMBr 15ml bioreactors and 2/10L glass bioreactors/fermenters
  • Development of scalable fermentation process (Fed batch / HD Fed batch / Continuous perfusion)
  • Development of scalable purification process (Batch / continuous)
  • Hold time studies.
  • Primary packaging compatibility studies
  • Formulation development and stability studies (Accelerated, Real time/Long term studies) of Drug substance and Product.
  • Freeze thaw studies and characterisation/mapping of protein behaviour at different temperatures.
  • Degradation / aggregation studies on intermediate product, drug substance and drug product.
  • Filter validation studies
  • Scale-down studies and titer improvement studies
  • Validation of analytical methods
  • Scaleup/Engineering batches (Drug Substance / Product) from 10L / 50L scale to 1000L / 2000L production scale and characterisation of the process, drug substance and Drug product.
  • Process validation batches at clinical and commercial scale
  • Secondary/tertiary packaging development
  • Conduct of Commercial batches (Drug Substance & Drug Product) at 50L, 200L, 1000L & 2000L bioreactor scale

Our DS Capabilities

Small Volume manufacturing
50Ltrs and 200Ltrs bioreactors (with and without perfusion)

Large Volume manufacturing
2 x 2000Ltrs Bioreactors and 4 x 1000Ltrs Bioreactor (total 8000 Ltrs)

Planned expansion
16000 Ltrs capability

Our DP Capabilities

Small Volume manufacturing
20 units/m (PFS and vial)

Large Volume manufacturing
40 units/m, Isolator (PFS and vial)

High Volume manufacturing
300 units/m vial filling (Size 2R to 100R)

Packaging Capabilities

PFS Plunger rod assembly& labelling machine
80 units / min.

PFS/vial blister packing machine
80 units / min.

Vial Stricker labelling machine
130 units / min.

CDMO Capabilities

Proprietary Technologies

  • Vector constructs
  • Media components
  • Continuous process for Mabs, fusion proteins and Glycoproteins
  • Engineered yeast strain, Engineered CHO cell line
  • High concentration liquid formulations for MAbs and fusion proteins

Technical Strengths: Backward Integrated – Clone Development to Manufacturing

  • Own cell lines, vectors, process development strengths
  • Complete inhouse characterisation of biologics with high end, high throughput analytical instrumentation
  • Own Cell banking, cell line characterisation facility

CDMO Capabilities