Shilpa Medicare Limited
FDA Approved • GMP Certified

Drug Product - Fill & Finish

Life-Changing Medicines

Learn more about our drug product (dp): aseptic fill-finish excellence 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 Drug Product (DP) services cover aseptic fill-finish, lyophilization, sterile packaging, and analytical release for vials, prefilled syringes, and cartridges. With state-of-the-art isolator/RABS technology and stringent quality systems, we ensure patient safety and regulatory compliance for both clinical and commercial programs.

Our Capabilities

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Aseptic Fill-Finish

Liquid & lyophilized products in vials, PFS, cartridges

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Lyophilization Expertise

Cycle design, optimization & scale-up

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Advanced QC & Analytics

Sterility, endotoxin, potency, particulate, CCI

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Packaging & Cold Chain

Serialization, labeling, real-time temperature monitoring

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Scalable Solutions

From early clinical to commercial supply

Detailed Step-by-Step Process

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1. Formulation & Sterile Filtration

Final formulation prepared under ISO-classified suites with pH and osmolality checks. 0.22 µm sterile filtration with validated filters and integrity testing (pre/post).

  • ISO-classified suites
  • pH & osmolality optimization
  • 0.22 µm sterile filtration
  • Filter integrity testing
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2. Aseptic Filling & Closing

Filling in isolators/RABS with automated systems. Supports liquid fills (vials, syringes, cartridges). Automated stoppering, sealing & capping with CCI checks.

  • Isolator/RABS technology
  • Automated filling systems
  • Multiple container formats
  • Container closure integrity
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3. Lyophilization (if required)

Optimized freeze-dry cycles (freezing, primary & secondary drying). Ensures long-term stability of proteins, peptides & mAbs.

  • Customized cycle development
  • Primary & secondary drying
  • Protein stability optimization
  • Real-time monitoring
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4. Visual Inspection & In-Process Controls

Automated & manual visual inspection for particles, fill volume, and integrity. In-process QC including bioburden, sterility checks, and filter integrity.

  • Automated inspection systems
  • Manual visual inspection
  • In-process bioburden testing
  • Real-time quality control
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5. Release Testing

Comprehensive testing including sterility (USP <71>), bacterial endotoxins (USP <85>), potency assays, purity, particulates, and extractables/leachables testing. Container Closure Integrity (CCI) validated methods.

  • USP Sterility testing
  • USP Endotoxin testing
  • Potency & purity assays
  • CCI validation
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6. Packaging & Logistics

Secondary packaging, serialization, and global cold-chain distribution. Temperature-controlled shipments with monitoring & deviation management.

  • Track & trace serialization
  • Cold-chain management
  • Temperature monitoring
  • Global distribution network

Regulatory & Quality Alignment

Our facilities and processes align with global regulatory standards:

  • EU GMP: Annex 1 - Manufacture of Sterile Medicinal Products
  • FDA Aseptic Processing Guidance: Current Good Manufacturing Practice for Sterile Drug Products
  • ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
  • USP Standards: USP <71> Sterility Tests, USP <85> Bacterial Endotoxins Test, USP <788> Particulate Matter
  • ISO 13408: Aseptic Processing of Health Care Products

Deliverables for Clients

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GMP Drug Product Batches

Clinical and commercial batches manufactured under full GMP compliance

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Certificates of Analysis (CoA)

Complete analytical data and stability reports for each batch

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Batch Records

Full batch documentation and regulatory submission packages

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Tech Transfer Packages

Comprehensive documentation for global regulatory submissions

Why Choose Our DP Services?

  • End-to-end integration: Seamless transition from drug substance to drug product
  • Flexible capacity: From small clinical batches to large commercial campaigns
  • Advanced technologies: State-of-the-art isolators, RABS, and automated systems
  • Quality assurance: Robust quality systems with zero tolerance for contamination
  • Regulatory expertise: Proven track record with FDA, EMA, and other global agencies
  • Supply chain reliability: On-time delivery with cold-chain integrity maintained

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