Therapeutic Protein
Coriolis Pharma specializes in the development and stability of therapeutic proteins. Our deep understanding of protein chemistry and advanced analytical capabilities ensures your therapeutic proteins are formulated and tested to meet the highest standards.
From antibodies and antibody-related products to alternative scaffold proteins, proteases, hormones, cytokines, growth factors, enzymes and protein-based vaccines (such as the hepatitis B vaccine), Coriolis employs a comprehensive approach to liquid and lyophilized therapeutic protein formulations.
Therapeutic Protein Services
No matter how unique your protein might be, Coriolis can draw from many years of experience working on several hundred therapeutic proteins and apply them to benefit your development program.
Specialized Therapeutic Protein Services and Capabilities
Coriolis science-driven solutions are based on our deep understanding of the specific challenges in developing a protein-based therapeutic drug product. Our expert scientists will devise dedicated study designs tailored to the needs of your protein and development phase.
High-Concentration Protein Formulation Development
High-concentration formulations of 100–200 mg/ml, subcutaneous injection, for example, can be a valuable alternative to intravenous application. High-concentration formulations are the only viable option for some applications, such as intravitreal injection.
We develop high-concentration protein formulations for liquid and lyophilized drug products. Our formulation scientists are experienced in overcoming the challenges of high concentrations, including aggregation, viscosity, syringeability and manufacturability.
Low-Concentration Protein Formulation Development
Highly potent therapeutic proteins, including bispecific antibodies, hormones and peptides, require a low-concentration formulation in the range of ng/ml or µg/ml. The development of such products comes with specific challenges, such as surface adsorption during manufacturing and clinical application and the need for high-sensitivity analytical characterization.
Coriolis has many years of experience developing low-dose drugs and an extensive portfolio of specialized analytical techniques for formulation development and clinical in-use studies. We develop robust formulations and sensitive analytical methods specific to your therapeutic protein.
Drug Product Development for Biosimilars
Patent protection of many therapeutic proteins is about to expire, and Coriolis actively supports clients developing biosimilar drugs with a dedicated drug development program.
For example, we conduct comparability studies with the originator product to assess stability and physicochemical characteristics. Considering the competitive intellectual property landscape, we also develop innovative formulations to achieve optimal freedom to operate with a stable and effective final drug product.
Content and Impurity Analysis
Analytical characterization of therapeutic proteins includes two essential aspects: protein content determination and identifying and quantifying impurities such as aggregates or particles.
Our experts develop tailored methods for analyzing your product’s content and purity or transfer and apply existing procedures to our laboratories. We optionally perform method optimization and qualification to ensure the highest data quality.
Therapeutic Protein Resources
Publications
April 12, 2024
Publications
April 1, 2024
Comprehensive Biotherapeutic Expertise
Our deep-rooted academic background, drug development and commercialization expertise keep us at the cutting edge of formulation science and analytical method development. This expertise enables us to support a wide range of modalities.
Talk to Our Experts or Request a Quote
Our expert team is ready to answer your questions and guide you to the services best suited to your program’s modality, stage and challenge. If your needs are well-defined, we’ll begin the quotation process.
Therapeutic Protein FAQs
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Therapeutic proteins are highly diverse and comprise antibodies, antibody-related products, hormones, cytokines, growth factors, enzymes and protein-based vaccines (such as the hepatitis B vaccine). A therapeutic protein may be as small as 20 kDa or be a multimeric protein complex of several MDa, and there can be substantial differences in their higher-order structure, physicochemical properties, stability profiles and potential degradation pathways.
Therapeutic proteins are still the largest class of biopharmaceuticals. More than 200 therapeutic proteins are currently on the market and used to treat a wide variety of medical needs. Yet many more promising therapeutic proteins are in preclinical and clinical development.
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We provide cutting-edge solutions for the formulation of therapeutic proteins, addressing issues such as aggregation, stability and delivery. Our formulations are designed to enhance the bioavailability and efficacy of your protein-based drug products. Our comprehensive analytical services include stability testing, forced degradation studies and characterization of protein interactions. These techniques ensure your therapeutic protein’s structural integrity and functionality throughout development.
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Coriolis offers end-to-end support for therapeutic protein development, from initial formulation to final product validation. Our expertise in handling complex proteins and robust analytical methods facilitates a streamlined development process, minimizing risks and accelerating your product’s path to market.