Biopharmaceutical Process Development
Our expert team takes a phase-appropriate approach to biopharmaceutical process development. While reproducibility is paramount and good manufacturing practice (GMP) considerations are kept front and center, processes become increasingly robust throughout development, derisking your path to a successful commercial product launch.
Drug Product Process Development Derisking Your Path to Market
Ensuring successful manufacturability—including clear paths to preclinical, clinical and commercial drug products—is the heart of Coriolis Pharma’s drug product process development programs under non-GMP.
We implement a phase-appropriate approach to help you efficiently reach your next milestone without compromising future requirements for a clinically and commercially viable process.
Stakeholder Collaboration Creates Robust Processes
We establish the baseline process under non-GMP, identify manufacturability gaps and collaborate with our clients or their contract development and manufacturing organizations (CDMOs) to define the scope of the process development program to establish GMP manufacturing processes at our clients’ or their CDMOs’ manufacturing sites.
Develop and Scale Drug Product Manufacturing Processes
Our team supports phase-appropriate drug product process development and analytical optimization based on process specifications and critical quality attributes. In collaboration with our clients and/or their CDMOs, we develop commercially viable drug product manufacturing processes to support successful clinical and market delivery.
Robust Process Development for Your Drug Product
We conduct non-GMP process development for many biopharmaceutical drug products, including highly concentrated protein formulations and active pharmaceutical ingredients like live virus vaccines, viral vectors or cell therapies under biosafety level 2.
Your Phase
Coriolis offers phase-appropriate drug product process development programs throughout the phases of development.
Biopharmaceutical Process Development Development Resources
Live Webinars
Developability Assessment and Early Formulation Studies for Biologics
February 27, 2025
Publications
December 2, 2024
Articles
Partnering with Scientific Excellence to Derisk and Accelerate Drug Development
July 15, 2024