Flexible Microbial Drug Substance Manufacturing

Overview

Shilpa delivers microbial (E. coli, yeast) upstream and downstream DS solutions with modern stainless-steel platforms, spanning early-stage process development through multi-100L commercial manufacturing. Our Microbial DS suite is housed in a ~1200 sqm facility with stainless-steel fermenters (20–1000 L), high-capacity centrifugation, chromatography, and TFF—enabling high-titre protein, enzyme, peptide, GLP-1, and insulin production.

Microbial DS Capabilities

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Dedicated Facility

~1200 sqm facility with complete infrastructure

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Harvest & Clarification

High-throughput processing capabilities

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Downstream Processing

Large-scale purification systems

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Product Portfolio

Diverse biologics production capability

Microbial DS Process

1. Seed & Fermentation

Seed train → stainless fermenters (20–1000 L); high-density culture for proteins, peptides, hormones

Optimized seed trains
High-density fermentation
Process control systems

2. Harvest & Clarification

Continuous centrifugation (1000 L/h), hollow fiber filtration (15 m²)

High-throughput harvest
Efficient clarification
Product stability

3. Downstream Purification

Chromatography (up to 2000 L/h), TFF (0.5–10 m²)

Multi-step purification
High-capacity systems
Quality optimization

4. Validation & Compliance

Process and cleaning validations throughout

Process validation
Cleaning validation
Regulatory compliance

Strategic Capacity Notes

Industry-Leading Scale:

Microbial fermentation capacity will reach 230,000 L when fully operational
Positioning Shilpa as one of the largest microbial biologics CDMOs in India and globally
Scalable infrastructure from development to commercial production
Support for multiple products and campaigns simultaneously

Regulatory & Strategic Advantages

Hybrid CDMO Model: Integrated mammalian + microbial capacity helps serve diverse biologics projects—from mAbs to peptides and GLP-1s—in both clinical and commercial phases
Scalable Infrastructure: Massive microbial capacity (230,000 L) offers unmatched scale flexibility
Strong Technical Foundations: High-end facility controls, extensive purification pipelines, and regulatory-grade equipment ensure quality and compliance

Deliverables

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GMP Drug Substance

Clinical and commercial batches

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Process Validation

Complete validation documentation & cleaning validation reports

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Certificate of Analysis

CoA with full analytics

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Technical Package

Process records, batch records, QC reports

Drug Substance - Microbial

Our Biologics Process Excellence

Cell Line Development

Upstream Processing

Downstream Purification

Fill & Finish