Drug Product Development
Coriolis Pharma’s extensive drug product development experience across a broad range of modalities allows us to serve as an expert guide throughout all phases of the drug development lifecycle. Additionally, our comprehensive capabilities empower us to solve the most complex drug product formulation, process development, characterization, stability and many other challenges right from the start.
Drug Product Development Services
Coriolis Pharma’s comprehensive drug product development services allow us to serve as an early accelerator, risk mitigator and problem solver for CMC and process development demands. We are also a reliable partner supporting late-phase development and commercialization activities related to your drug product.
Accelerator Platforms
Preclinical drug development solutions allow you to go from molecule to formulation within a few weeks, reducing time to market, decreasing costs and mitigating risk.
Preformulation Studies
Select the most promising lead molecule(s) by conducting a developability assessment or identify the most stable formulation by executing preformulation screening. Holistically, preformulation studies allow you to characterize the physicochemical properties of your lead molecule(s) and determine the impact of environmental factors.
Formulation Development
Formulation development services create robust biopharmaceutical products for manufacturing, storage, handling and patient administration.
Lyophilization Process Development
Lyophilization process development services are tailored to your specific drug product development needs from phase I clinical trials through late-stage and commercial manufacturing, considering process development, scale-up and tech transfer.
Comparability Studies
Understand how slight changes in formulation conditions or the production process impact critical quality attributes of the drug product. Additionally, robust comparability studies are vital for successful biosimilar development programs.
Stability Studies
Critical quality attributes (CQA) and relevant degradation pathways are monitored to ensure your drug product’s efficacy, quality and safety over its intended shelf life.
In-Use Stability Studies
Comprehensive studies allow you to understand the clinical and commercial environment’s impact on drug product stability.
Forced Degradation Studies
From preformulation to late-stage formulation development, our experts allow you to understand the impact of stressors on your drug product. They can design forced degradation studies for the intended purpose and development phase.
Biopharmaceutical Process Development
Our proven process development approaches enable the transition of the selected formulation from non-GMP to GMP facilities (in-house/CDMO). The manufacturing of non-GMP tech batches confirms the suitability of the drug product manufacturing process by utilizing representative or equivalent equipment.
Your Drug Product
Coriolis Pharma’s deep expertise across many biologic modalities, combined with input from world-leading external advisors, offers the knowledge and experience needed 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.
Drug 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 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 the knowledge from working with hundreds of drug products to solve this viscosity and protein aggregation issue.
Drug Product Development Resources
Publications
Stability of Jurkat cells during short-term liquid storage analyzed by flow imaging microscopy
April 7, 2025
Press Releases
March 11, 2025
Drug Product Development Frequently Asked Questions (FAQs)
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Drug product development refers to the process of transforming a drug substance into a finished dosage form suitable for clinical or commercial use. This includes formulation development, stability studies, process development, and manufacturing considerations.
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Coriolis Pharma supports a wide range of biologics, including antibodies, peptides, therapeutic proteins, viral vectors, gene and cell therapies, nucleic acids, vaccines, and nanoparticulate delivery systems.
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Yes. Coriolis offers accelerator platforms and preclinical development solutions that rapidly move your molecule to formulation in just a few weeks, saving time, reducing costs, and mitigating risk early in the development process.
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Coriolis develops robust formulations optimized for manufacturability, stability, and patient use. Services span from preformulation screening and forced degradation studies to high-concentration formulation and lyophilization process development.
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Absolutely. Coriolis designs and executes ICH-compliant stability studies, in-use stability testing, and comparability studies to evaluate the impact of formulation or process changes, which is critical for regulatory success and lifecycle management.
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Yes. Coriolis has extensive experience developing high-concentration formulations, including subcutaneous delivery systems for monoclonal antibodies, helping clients reduce injection volume while maintaining stability and viscosity targets.
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Our process development strategies ensure a seamless transition from non-GMP to GMP manufacturing. Coriolis supports tech transfer, scale-up, and production of non-GMP technical batches using representative equipment to confirm process suitability.
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Yes. Coriolis provides full CMC support from early phase through commercialization. We are a strategic partner for formulation refinement, comparability, and scale-up, helping clients navigate regulatory and manufacturing milestones.
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With expertise across 930+ modalities and collaboration with global scientific advisors, Coriolis combines scientific rigor, flexible problem solving, and a deep understanding of complex biopharmaceutical systems to drive success at every phase.
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Contact us to discuss your specific needs. Our team will evaluate your molecule, development goals, and phase of development to recommend a customized program aligned with your regulatory and commercialization strategy.
