Antibody or related product
Science-driven solutions for your antibody or antibody-related drug product
Antibodies, also known as Immunoglobulins (Ig), are an important subgroup of therapeutic proteins. They come in several variations - IgA, IgD, IgE, IgG and IgM - among which, IgG is the most frequently used for therapy today. While classical antibody drug products comprise the entire antibody including its antigen-binding site and the Fc part, other types of antibody-related products have been developed with diverse designs, for therapeutic and diagnostic purposes. These include:
- Fab fragments, utilizing only the antigen binding fragment
- Fc-fusion proteins, where an Fc part is coupled to e.g., a receptor
- Bi- or tri-specific antibodies, which can bind to multiple antigens
- Single-chain variable fragments (scFv), employing only the variable part of the Fab fragment
- Nanobodies, also called single domain antibodies (sdAb), which only use the variable part of one antibody domain
Binding affinity and specificity
The fundamental function of an antibody and antibody-related product is to bind a designated target with high specificity and affinity. The structural and chemical integrity of the molecules are crucial for their function. During drug product development, Coriolis applies phase-appropriate and stability indicating methods to assess the physical and chemical integrity as well as binding affinity. Our expert scientists apply tailored forced-degradation studies to reveal critical degradation pathways, so your drug product remains effective and safe until application.
Aggregation and particle formation
Antibodies and antibody-related products are –like other proteins – prone to aggregation. While the presence of a small number of aggregates may be uncritical, aggregation and the formation of protein particles indicates a stability problem or issue with the formulation. The presence of aggregates and particles may also negatively impact the safety of the therapy through unwanted immunological side effects. That’s why we include a comprehensive set of analytical techniques during drug product development and trouble shooting.
Coriolis is your partner with scientific excellence
With 14+ years of experience in drug product development for full-size antibodies as well as antibody-related products, Coriolis is your expert partner of choice. We consider the individual aspects of your development program or analytical challenge and tailor our services to your need. Together, we can make future therapies available to patients and improve the quality of life for humankind.
Specialized services for your antibody or antibody-related product
Coriolis science-driven solutions are based on our deep understanding of the specific challenges of developing an antibody-based therapeutic drug product. Our expert scientists will devise dedicated study designs tailored to the needs of your product 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.
Determining the binding affinity
A fundamental feature of antibodies and antibody-related products is the ability to bind a specific epitope. The binding kinetic is, thus, one of the most crucial aspects of such products.
Coriolis offers several analytical techniques to characterize the binding affinity and related kinetics including surface plasmon resonance (SPR, Biacore), enzyme linked immunosorbent assay (ELISA) and analytical ultracentrifugation (AUC). We can also perform cell-based binding and activity assays.
Development services for your antibody or antibody-related product
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 antibody or antibody-related product
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 antibodies and antibody-related products
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.
Dominik Brandstetter, Constanze Helbig, Kentaro Osawa, Hiroyuki Minemura, Yumiko Anzai, Tetsuo Torisu, Susumu Uchiyama, Tim Menzen, Wolfgang Friess, Andrea Hawe
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.