Therapeutic protein products developed with scientific excellence
Coriolis is the expert partner for the biopharmaceutical industry. Since our foundation, we support our clients in developing innovative protein therapies as well as biosimilar drug products and help to improve the lives of patients around the world.
Therapeutic proteins are still the largest class of biopharmaceuticals. More than 200 therapeutic proteins are currently on the market and used to treat a large variety of medical needs. Yet there are many more promising therapeutic proteins in pre-clinical and clinical development. As a trusted partner, Coriolis is delivering outstanding biopharmaceutical research, development, and analytical services to bring safe and effective therapies to the patients.
Therapeutic proteins are very diverse
Therapeutic proteins are extremely 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, physico-chemical properties, stability profiles and potential degradation pathways.
No matter how special or delicate your protein might be, Coriolis can draw from many years of experience in working on several hundred different therapeutic proteins and apply it to the benefit of your development program. We tailor our services to your needs and help you obtain an effective and safe therapeutic drug product.
No matter how special or delicate your protein might be, we tailor our services to your needs and help you obtain an effective and safe therapeutic drug product.
Antibodies and related products
Antibodies, also known as Immunoglobulins (Ig), are an important subgroup of therapeutic proteins. Coriolis offers a variety of research, development, and analytical services dedicated to full size antibodies (e.g., IgG or IgM), as well as antibody related products, such as Fab fragments, Fc-fusion proteins, bi- or tri-specific antibodies, single-chain variable fragments (scFv) and nanobodies (also called single domain antibodies, sdAb).
Sub-unit vaccines contain purified proteinaceous or sometimes polysaccharides of the infectious pathogen as antigens for immunization. These include soluble protein, protein nanoparticle and virus-like particle vaccines. The structural and chemical integrity of the protein is – just like for therapeutic proteins – critical for the effectivity and safety of the vaccine. As such, the stability of the protein subunit against chemical of physical degradation should be assured through a dedicated formulation development and verified during stability and forced degradation studies. In close interaction with our clients, we address aspects like antigen-adjuvant interaction, how and when to combine antigen with adjuvant and the required characterization strategy.
Coriolis supports the development of vaccines with a large portfolio of dedicated services. Our team includes expert scientists, who are specialized in the development of vaccines and our scientific advisory board with distinguished academic experts in the vaccine field.
Specialized services for your therapeutic protein
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 for e.g., subcutaneous injection can be a valuable alternative to intravenous application. For some applications, such as intravitreal injection, high concentration formulations are the only viable option.
We develop high concentration protein formulations for liquid as well as lyophilized drug products. Our formulation scientists are experienced in overcoming the challenges related to 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 or ng/ml or µg/ml. The development of such products comes with certain challenges such as surface adsorption during manufacturing and clinical application, as well as the need for high-sensitivity analytical characterization.
Coriolis has many years of experience in developing low-dose drugs and a large portfolio of specialized analytical techniques for formulation development and clinical in-use studies. We develop robust formulations and sensitive analytical methods specific for your therapeutic protein.
Drug product development for biosimilars
Patent protection of many therapeutic proteins are about to expire, and Coriolis actively supports clients developing biosimilar drugs with a dedicated drug development program.
We conduct, for example, comparability studies with the originator product to assess stability and physico-chemical characteristics. We also develop innovative formulations considering the competitive IP landscape 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 important aspects: protein content determination and the identification and quantification of impurities such as aggregates or particles.
Our experts develop tailored methods for content and purity analysis of your product or transfer and apply existing procedures to our laboratories. We optionally perform method optimization and qualification to assure the highest data quality.
Development services for your therapeutic protein
Explore our large portfolio of development services. In a unique collaborative approach, we individually design each study to meet your expectations and the needs of your current development phase. You will benefit from the scientific experience and advise of our expert scientists to achieve your development goals faster and with a higher chance of success.
Analytical services for your therapeutic protein
Choose from a large set of analytical techniques in a variety of categories or get our expert opinion on the most suitable methods for your analytical challenge. We offer standardized analytical methods for many common sample types and perform dedicated method development specific for your analytical challenge and drug product. Explore our analytical portfolio ranging from discovery phase analysis to lot release testing methods.
Our know-how related to therapeutic proteins
Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles and webinars.
Other product types
We tailor our services to your specific product type and development phase. In a unique collaborative approach, our expert scientists focus on your scientific question or development milestone and support your drug development program with their many years of experience. Select your product type to learn more about our services.