Drug Product Manufacturing

Rows of sealed vials move along an automated production line in a cGMP drug substance manufacturing facility, ensuring compliance and quality control.

Drug Product Manufacturing Services for Biologics

Pharmaron’s biologics manufacturing facilities offer a full range of drug product (DP) services for biologics, including vial and pre-filled syringe (PFS) production for both liquid and lyophilized products. With advanced fill/finish lines and global brand devices, we deliver high-quality, reliable solutions tailored to meet the needs of clinical trial materials and market-ready products. Our expertise ensures performance, scalability, and compliance with global quality standards.

From small clinical batches to large commercial lots, Pharmaron’s facilities are equipped to handle diverse biologics manufacturing needs. With a focus on precision and sterility, we offer customizable solutions that streamline production while maintaining product integrity at every stage.

Sterile manufacturing equipment with glove ports and conveyor system for flexible drug product production in a controlled cleanroom environment.

Filling Line Capacity:

  • Automatic Vial Filling Line:
    • Filling speed: 10,000 vials/hour (10R)
    • Vial sizes: 2R-50R
    • Features: Filling speed check, Class B and Class A open restricted access barrier systems (oRAB)
  • Automatic PFS Filling Line:
    • Filling speed: 8,000 PFS/hour
    • System: Peristaltic pump with single-use filling system
    • Features: Filling weight check, Class B and Class A open restricted access barrier systems (oRAB)
Advanced drug manufacturing isolator system with integrated lyophilization and pre-filled syringe (PFS) solutions in a sterile production setup.

Advanced Technology

Lyophilization Expertise

Pharmaron’s lyophilization capabilities ensure precise temperature control and process consistency for sensitive biologics. Our freeze-drying technology maintains product stability and extends shelf life, which is essential for biologics requiring long-term storage or specialized transportation.

Pre-Filled Syringe (PFS) Solutions

Our pre-filled syringe manufacturing is designed for filling accuracy and patient safety. We utilize single-use parts and consumables for optimal product integrity, which reduces contamination risks and enhances product sterility throughout the fill/finish process.

Isolator-based manufacturing system with integrated glove ports and touchscreen interface, designed for custom drug product production in sterile conditions.

Integrated Sterility and Quality Control

Pharmaron’s DP manufacturing incorporates stringent quality control measures to ensure sterility and product safety at every stage of the fill/finish process. Key features include:

  • Real-Time Filling Weight Checks: Precise monitoring during production to maintain consistency and accuracy
  • Advanced Barrier Systems (oRAB): Ensures aseptic conditions, minimizing contamination risks
  • Global Compliance Standards: Processes aligned with regulatory requirements to safeguard product integrity
Gloved hand handling sealed vials arranged in a tray, emphasizing integrated sterility and rigorous quality control processes in the lab.

Custom Solutions for Every Phase

Flexibility

Pharmaron offers complete flexibility for drug product manufacturing, from clinical trial materials to market-ready biologics. Whether you require standalone fill-and-finish services or support throughout multiple stages of development, we can accommodate our client’s project’s unique needs.

Tailored Services Include:

  • Vial and Pre-Filled Syringe (PFS) Filling
  • Lyophilization for Biologics
  • Scalable Fill and Finish Solutions with Adjustable Line Speeds
  • Integrated Quality Control and Sterility Assurance

Partner with Pharmaron for Excellence in Drug Product Manufacturing

Ready to ensure your biologics achieve the highest quality standards? Contact our experts today to discuss tailored solutions for your drug product manufacturing needs.

A scientist in sterile blue attire operates large bioprocess equipment in a cGMP drug substance manufacturing facility, managing tubing and machinery.