Shilpa Medicare Limited
FDA Approved • GMP Certified

Drug Product (DP): Aseptic Fill-Finish Excellence — Delivering Safe, Stable & Scalable Biologics

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

Aseptic Fill-Finish

Liquid & lyophilized products in vials, PFS, cartridges

Lyophilization Expertise

Cycle design, optimization & scale-up

Advanced QC & Analytics

Sterility, endotoxin, potency, particulate, CCI

Packaging & Cold Chain

Serialization, labeling, real-time temperature monitoring

Scalable Solutions

From early clinical to commercial supply

Detailed Step-by-Step Process

1

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
5

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

GMP Drug Product Batches

Clinical and commercial batches manufactured under full GMP compliance

Certificates of Analysis (CoA)

Complete analytical data and stability reports for each batch

Batch Records

Full batch documentation and regulatory submission packages

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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