Formulation Development
Our experts develop robust formulations from early research to late-phase development, effectively managing and stabilizing often inherently unstable biopharmaceutical molecules. Advanced formulation development services enable robust biopharmaceutical drug products for manufacturing, storage, handling and patient administration.
Liquid, Frozen and Lyophilized Biologics Formulations Tailored to Your Needs
We develop phase-appropriate formulations for liquid, frozen and lyophilized drug products, focusing on your target product profile (TPP) and designing the study to meet your requirements. We consider drug substance availability, relevant deadlines and your overall development strategy when conducting a project. You and your team will benefit from the advice of our distinguished scientific advisory board. Additionally, our comprehensive capabilities offer the flexibility to readily switch from a liquid to a lyophilized formulation or explore formulation types in parallel.
With considerable biologics formulation development experience and expertise, we offer the following:
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Studies designed to identify suitable formulation corridors and compositions (pH, ionic strength, protein concentration, excipients, etc.) identify degradation products and develop and select stability-indicating methods. Additionally, using high-throughput formulation approaches based on the design of experiments reduces the required material and time.
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Liquid, frozen or freeze-dried formulations are commonly developed for toxicological studies and can be produced under aseptic conditions.
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We can transfer your formulation to our process development team or to your chosen contract manufacturing organization (CMO). This flexibility reduces costs and helps to minimize risks.
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Our biologics formulation experts will help you quickly reach the clinic. We can address formulations in different primary packaging materials such as vials, prefilled syringes or cartridges and tackle challenging tasks like high-concentration formulations.
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We will ensure your formulation is scalable and can meet the demands of late-phase development and commercial production.
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.
Formulation Development Designed for Your Drug Product
Coriolis Pharma’s deep expertise across many biologic modalities and input from world-leading external advisors offer the knowledge and experience to solve even the most complex formulation and drug development challenges.
Your Phase
Our expert team has the knowledge and experience to guide your program from discovery to preclinical drug development, through clinical phases and to the market.
Formulation Development Resources
Publications
August 1, 2023
Publications
Reversed Phase Liquid Chromatography for Recombinant AAV Genome Integrity Assessment
May 23, 2023
