Early-Phase Drug Development
Coriolis Pharma understands the need to get to the clinic as quickly as possible while derisking late-phase development by laying the groundwork for success. Our team of experts is fast and flexible, tackling issues like bioavailability and stability challenges as they arise, allowing you to meet your milestones and keep your program on track.
Early Phase
Our Early-Phase Services
To begin first-in-human (FIH) studies as quickly as possible, our early-phase development experts leverage their scientific expertise to strategically advance your program, reducing risks and saving time and money as your drug product progresses through its development phases.
Early-Phase Drug Development Services
Our portfolio of early-phase drug development services identifies the most suitable candidates and formulations to build the foundation for success throughout your product’s entire lifecycle, significantly lessening the risks of failure.
Early-Phase Analytical Services
As your drug product moves toward the clinic, Coriolis Pharma’s analytical services become more robust, further characterizing your product and setting the stage for later-phase and commercial success. We utilize more than 200 predesigned and validated methods and conduct method development and qualification for any custom method development your program requires. We begin developing GMP methods and performing GMP compendial method verification at this phase.
Early-Phase Manufacturing Services
Coriolis provides comprehensive early-phase manufacturing services with a phase-appropriate approach to process development, ensuring reproducibility and robust GMP processes. Our expertise in release testing under GMP conditions, non-GMP manufacturing for toxicology studies and lead lot stability material production supports your drug product’s development and stability monitoring.
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.
Early-Phase Development Project Success Story
Changing a Low-Concentration Intravenous to a High-Concentration Subcutaneous Formulation
The Challenge
Changing the application route of a monoclonal antibody (mAb) from intravenous to subcutaneous, thereby increasing the concentration to 200 mg/ml. The client’s initial development efforts resulted in viscosity issues and protein aggregation.
Our Solution
Our scientists developed an innovative self-buffering formulation with only a few amino-acid additives that stabilized the protein and reduced its viscosity. The formulation met the client’s target product profile (TPP).
The Coriolis Effect
Our liquid formulation group has successfully developed multiple high-concentration protein formulations. They applied their knowledge from working with hundreds of drug products to solve this viscosity and protein aggregation issue.
Early-Phase Drug Development Resources
Publications
October 8, 2024
Articles
August 6, 2024
Articles
Streamlining the Path to Approval with Developability and Pre-Formulation Platforms
July 18, 2024
Articles
Partnering with Scientific Excellence to Derisk and Accelerate Drug Development
July 15, 2024
