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.

We’ve worked with more than 930 compounds, and that number is growing by the day.

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. We’ve worked with more than 930 compounds, and that number is growing by the day.

Antibody or Related Product Development

Peptide

Therapeutic Protein

Gene & Cell Therapy

Viral Vector

Nucleic Acid

Vaccine

Nanoparticulate Delivery Systems

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.

Preclinical

Early Phase

Late Phase & Commercialization

Commercial Services

Coriolis Effect

See how our expertise and comprehensive services accelerate biologics development from preclinical 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.