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.
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
Our DS Capabilities
Small Volume manufacturing 50Ltrs and 200Ltrs bioreactors (with and without perfusion) Large Volume manufacturing2 x 2000Ltrs Bioreactors and 4 x 1000Ltrs Bioreactor (total 8000 Ltrs) Planned expansion16000 Ltrs capability
Our DP Capabilities
Small Volume manufacturing20 units/m (PFS and vial) Large Volume manufacturing40 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 machine80 units / min. PFS/vial blister packing machine80 units / min. Vial Stricker labelling machine130 units / min.
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
