Drug Product Development

Scientists in a laboratory performing drug product development tasks with pipettes, safety goggles, and masks, ensuring precision and compliance.

Comprehensive Drug Product Development Solutions

Pharmaron offers a full suite of drug product development (DPD) solutions for biologics designed to support your project from the early stages of developability assessment through to the final fill-and-finish process. Our expert team leverages cutting-edge technologies to ensure your biologics are formulated, developed, and manufactured with the highest precision, quality, and compliance.

With a focus on tailored solutions, our biologics drug product development services can be fully integrated into your broader pipeline or delivered as standalone services to address your specific project needs.

Two scientists in protective gear use a Lumos II instrument for analytical testing, supporting comprehensive developability assessment services.
Circular drug product development (DPD) workflow highlighting stages like formulation assessment, filling, particle analysis, and clinical in-use study.

Our Drug Product Development Workflow

A comprehensive drug product development (DPD) workflow ensures that every critical phase of biologics development is addressed, from the initial formulation assessment to the fill-and-finish process. With expertise in liquid and lyophilized product development, this approach guarantees product stability, safety, and efficacy at each stage. Our DPD services focus on the critical aspects of biologics development.

Scientists in a laboratory working on the drug product development process, utilizing advanced equipment and computers in a cleanroom environment.

Developability and Stability Assessment for Biologics

  • Molecule Developability Assessment: Evaluating formulation feasibility
  • Physiochemical Property Characterization: Assessing key biological and chemical properties
  • Stability Assessment: Testing product stability under varied conditions
  • Forced Degradation Studies: Assessing the stability and understanding the degradation pathway under the impact of stress conditions
  • Liquid & Lyophilized Product Development: Developing robust formulations for both formats
  • Pre-filled Syringe Development: Creating pre-filled syringe systems
Scientist operating chromatography equipment for protein purification in a laboratory, ensuring precise downstream process development with PPE compliance.

Biophysical Characterization and Safety Testing Services

  • Container Closure Testing: Ensuring packaging compatibility and integrity
  • Extractable and Leachable Studies: Identifying potential risks from packaging materials
  • Biophysical Characterization: Understanding your product’s physical properties
  • Technology Transfer: Ensuring a smooth transition to manufacturing
  • In-use Stability Studies: Verifying product safety and stability during toxicology and clinical use
  • Forensic Analysis: Solving complex formulation or production issues

Ready to Scale Your Biologics Production?

Partner with our experts to accelerate your biologics development. Learn how our tailored solutions can optimize every stage of your process, from formulation to final product. Contact us today to discuss how we can support your project.

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