Lyophilization Process Development
Coriolis Pharma’s team of experts is highly experienced in developing, optimizing, scaling up and transferring lyophilization cycles for biopharmaceutical drug products. To create robust and economical freeze-drying cycles, we conduct a stepwise lyophilization process development program tailored to your product’s characteristics, formulation and the needs of your development phase.
Lyophilization Modeling That Delivers Outstanding Process Understanding
Our Lyophilization Modeling (Lyo-Modeling) capabilities allow us to generate excellent process understandings and can be integrated into our clients’ QbD-based development strategy for regulatory submissions. The model-based approach integrates scientific principles, empirical data and mathematical modeling to optimize and control the lyophilization process. This approach enhances understanding, reduces development time and improves product quality and process efficiency.
From the start, our expert scientists consider the critical variables of each freeze-drying step to maintain the target shelf life, an elegant cake appearance and an economical lyophilization process.
5 Steps for Successful Lyophilization Process Design
We analyze in-process samples using a comprehensive set of process analytical technology (PAT) and physicochemical characterization methods suitable for lyophilizates. This approach ensures the robustness of the freeze-drying processes and enables high-quality, efficient production of lyophilized drug products.
Critical product temperatures
Process development
Process optimization
Process scale-up
Process transfer
Lyophilization Process Development Tailored to Your Drug Product
We operate freeze dryers from lab to production scale and develop processes for many different biopharmaceutical drug products, including highly concentrated protein formulations, organic solvent-containing formulations and drug substances like live virus vaccines and viral vectors that fall under biosafety level 2.
Your Phase
Our expert team has the knowledge and experience to guide your lyophilization development from preclinical to late-phase process development and process optimization. They can support the development in the early phase and give guidance on whether to go for a liquid or lyophilized formulation. In addition, Coriolis can support the conversion from a frozen-liquid to a lyophilized formulation to give our clients an advantage in the market.
Lyophilization Process Development Resources
Publications
December 1, 2023
Publications
November 5, 2023
Publications
January 24, 2023
Publications
Systematic Studies on Stabilization of AAV Vector Formulations by Lyophilization
March 1, 2022
