Preclinical Drug Development
Coriolis Pharma knows how critical it is to get your therapeutic to the clinic as quickly as possible while constructing a robust preclinical drug development program that derisks late-stage development and lays the groundwork for commercial success. Our expertise in navigating the demands of preclinical drug development for ranging biotherapeutic modalities sets programs on the right path right from the start.
Discovery/Preclinical Phase
Our Preclinical Services
Whether comprehensive IND-enabling programs or more targeted preclinical studies, our preclinical development experts leverage their scientific expertise, creativity and commitment to excellence to design the right path for your program, saving time and money.
Preclinical Drug Development Services
Our portfolio of preclinical drug development services identifies the most suitable candidates and formulations and builds the foundation for success throughout your product’s entire lifecycle, significantly lessening the risks of failure.
Preclinical Analytical Services
Coriolis Pharma’s analytical services, designed and delivered by our team of experts, allow us to serve as an early accelerator, thoroughly characterizing your drug product to support successful regulatory filings and late-phase development. We utilize more than 200 predesigned and validated methods and conduct method development and qualification for any custom method development your program requires.
Preclinical Manufacturing Services
Coriolis Pharma’s non-GMP manufacturing services include process development and non-GMP drug product manufacturing. Our services include the manufacturing of liquid and lyophilized products in a wide variety of formats and batch sizes, scale-up batches, robustness testing or support in technical transfer projects combined with tailored analytical testing.
Your Drug Product
Our experts enable early-phase development success, accelerating and derisking drug development programs. We have extensive experience with many different 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.
mAbs Accelerator Platforms
Kick-start your program with our developability assessment and preformulation screening services. Leveraging our extensive scientific expertise, we’ve crafted these platforms to help you identify the optimal strategy from the outset and address potential stage-related risks.
Preclinical Project Success Story
Overcoming Challenges for AAV Analytics
The Challenge
A preclinical adeno-associated virus (AAV) preparation showed a very low titer and high quantities of cell debris. The client needed a detailed characterization and quantification of empty, partially filled and full capsids.
Our Solution
After screening different analytical approaches for their feasibility, including ion-exchange chromatography (IEX) and transmission scanning microscopy, we could successfully develop an analytical ultracentrifugation (AUC) method, which accurately quantified the three species in the samples.
The Coriolis Effect
Coriolis has a large portfolio of 200+ analytical techniques and is also the largest provider of AUC services worldwide. With many analytical experts, we push the limits of our techniques to benefit our clients.
Preclinical Drug Development Resources
Publications
December 2, 2024
Articles
August 6, 2024
Articles
Streamlining the Path to Approval with Developability and Pre-Formulation Platforms
July 18, 2024
