Shilpa Medicare Limited
FDA Approved • GMP Certified

Small Scale Manufacturing

Life-Changing Medicines

Learn more about our small scale manufacturing services and capabilities.

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Biologics Manufacturing Equipment
99.5%
Purity Standard
24/7
Process Control

Our Biologics Process Excellence

Cell Line Development

CHO/HEK cell line development and optimization for high productivity and robust performance.

Upstream Processing

Fed-batch and perfusion processes across multiple scales with 24/7 process monitoring and control.

Downstream Purification

Multistep chromatography, filtration and UF/DF delivering high-purity drug substance.

Fill & Finish

Aseptic fill-finish support through partners and/or internal drug product capabilities.

Overview

Our small-scale manufacturing platform supports early clinical programs with rapid tech transfer, single-use bioreactors (1–200 L), modular purification skids, and comprehensive analytical support. Designed to accelerate Phase I/II studies, we ensure seamless scale-up to commercial production.

Core Capabilities

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Bioreactors: Single-use 1 L → 200 L (mammalian or microbial)
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Process Development: DoE optimization for media, feeds, chromatography
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Analytics: Method development & validation (ICH Q2 compliant)
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Clinical Supply: GMP batches with full stability studies & QA release
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Tech Transfer: Comprehensive documentation for seamless scale-up

Detailed Step-by-Step Process

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1. Process Development

Design of Experiments (DoE) to optimize critical parameters (feeds, pH, DO, chromatography conditions).

  • Critical parameter optimization
  • Feed strategy development
  • pH and DO control
  • Chromatography optimization
2

2. Pilot-Scale Runs

Execution in 1–200 L single-use bioreactors with scalable seed trains.

  • Single-use technology
  • Scalable seed trains
  • Process characterization
  • Scale-down models
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3. Downstream Purification

Lab chromatography skids for capture/polishing, UF/DF for concentration & buffer exchange.

  • Capture chromatography
  • Polishing steps
  • UF/DF concentration
  • Buffer exchange
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4. Analytical & QC

Development & validation of potency, purity, HCP, DNA, endotoxin, and sterility assays.

  • Potency assays
  • Purity analysis
  • HCP & DNA testing
  • Endotoxin & sterility
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5. GMP Clinical Batches

Produced under QA oversight for Phase I/II clinical studies.

  • Full QA oversight
  • Phase I/II support
  • Batch documentation
  • Release testing

Deliverables

Batch Records

Complete manufacturing batch records with full traceability

Certificate of Analysis

CoA with comprehensive quality testing results

Analytical SOPs

Validated analytical methods and procedures

Stability Reports

Real-time and accelerated stability data

Regulatory Documentation

Complete package for IND/IMPD filings including CMC sections

Quality & Regulatory

  • ICH Q2(R1): Analytical validation
  • ICH Q1A: Stability studies
  • QA oversight: Full GMP compliance for clinical trial materials

Related Content

DS Microbial - Large Scale

Large-scale commercial microbial production up to 15,000L

Drug Substance - Microbial

Comprehensive microbial drug substance manufacturing capabilities

Drug Substance - Mammalian

Mammalian cell culture for monoclonal antibodies and complex proteins

Biologics Overview

View our complete biologics services portfolio

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