Late-Phase Drug Development & Commercialization
At Coriolis Pharma, we understand the importance of refining and validating your drug product in vials, syringes and cartridges as it moves closer to market approval. Our comprehensive suite of late-phase services is designed to ensure the highest quality, efficacy and safety standards. From optimizing formulations to conducting rigorous stability studies, our experts are here to support your drug development journey.
Late-Phase and Commercialization Phase
Our Late-Phase Drug Development and Commercialization Services
Our late-phase development services are tailored to address the unique challenges and regulatory requirements of advancing your drug product toward commercialization. We leverage our extensive experience and state-of-the-art facilities to deliver reliable and efficient solutions.
Late-Phase Drug Development and Commercialization Services
Our portfolio of late-phase drug development and commercialization services ensures your product meets the highest quality and efficacy standards. We provide the critical support needed to navigate regulatory requirements and achieve successful market approval of your drug in vials, syringes and cartridges.
Late-Phase and Commercialization Analytical Services
Coriolis Pharma’s analytical services become increasingly comprehensive as your drug product moves toward market approval. We provide the rigorous testing and validation needed for market approval and commercial success. We offer a wide array of validated methods and custom method development to meet regulatory requirements and ensure product quality.
Late-Phase and Commercialization Manufacturing Services
Coriolis offers late-phase manufacturing services and commercialization support focusing on process development and optimization for commercial scalability and regulatory compliance. Our reliable GMP release testing and expert troubleshooting ensure consistent product quality and smooth drug development. Additionally, we provide comprehensive support for biologics license application (BLA) regulatory submissions, ensuring your product meets all market approval requirements.
Your Drug Product
Our experts enable preclinical success, accelerating and derisking drug development programs. We have extensive experience with biopharmaceutical drug products, including highly concentrated protein formulations and active pharmaceutical ingredients (APIs) like live virus vaccines and viral vectors that fall under biosafety level 2.
Late-Phase Development Project Success Story
Identifying In-line Filter as a Source of Particles During Clinical Application
The Challenge
A therapeutic protein product with a good stability profile in the primary packaging showed elevated quantities of visible particles after in-use handling.
Our Solution
An in-use stability study was designed that included the identification of the visible particles. The particles were identified as cellulose fibers originating from the in-line filter. We resolved the issue by changing to an optimized type of in-line filter.
The Coriolis Effect
We assemble interdisciplinary teams of experts specific to each project. In this case, one of our many pharmacists experienced with clinical procedures and product handling was part of the team. Together with experienced analytical scientists performing particle identification, the team could identify the root cause and solve the issue quickly.
Late-Phase Drug Development and Commercialization Resources
Publications
December 2, 2024
Publications
April 1, 2024
Publications
A Model-Based Optimization Strategy to Achieve Fast and Robust Freeze-Drying Cycles
December 1, 2023
