Antibody or Antibody-Related
With many years of experience in drug product development, Coriolis Pharma is your expert partner from preclinical to commercialization. Specializing in monoclonal antibody therapeutics (mAbs) and antibody-related products, we tailor our services to your specific needs, considering the individual aspects of your development program or analytical challenges to best position your candidate for commercialization.
By choosing Coriolis, you gain a partner dedicated to making future therapies more widely available to patients worldwide.
Your Full Product Lifecycle Partner for Therapeutic Antibody & Antibody-Related Products
Coriolis Pharma’s deep expertise in formulation science and experience with a variety of mAbs and other therapeutic antibodies equip us to support the entire product lifecycle.
Specialized Therapeutic Antibody & Antibody-Related Product Services and Capabilities
Coriolis science-driven solutions are based on our deep understanding of antibody-based therapeutic drug development challenges.
We specialize in the development of a variety of antibody and antibody-like products, including:
- Fab fragments, utilizing only the antigen-binding fragment
- Fc-fusion proteins, where an Fc part is coupled to, for example, 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
High-Concentration Protein Formulation Development
High-concentration formulations (100–200 mg/ml) for subcutaneous and intravitreal injections can be valuable alternatives to intravenous applications. Our experienced formulation scientists develop high-concentration protein formulations for liquid and lyophilized drug products to address challenges like aggregation, viscosity, syringeability and manufacturability.
Binding Affinity
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.
mAbs Accelerator Platforms
Kick-start your program with our developability assessment and preformulation screening services. Leveraging our extensive scientific expertise, we’ve crafted these platforms to help you identify the optimal strategy from the outset and address potential stage-related risks.
Therapeutic Antibody & Antibody-Related Product Resources
Publications
October 8, 2024
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 Antibodies FAQs
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Antibodies, also known as immunoglobulins (Ig), are an important subgroup of therapeutic proteins. They come in several variations—IgA, IgD, IgE, IgG and IgM—of 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 antibody-related products have been developed with diverse designs for therapeutic and diagnostic purposes.
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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. Coriolis applies phase-appropriate and stability testing methods to assess the physical and chemical integrity and binding affinity during drug product development. Our expert scientists apply tailored forced-degradation studies to reveal critical degradation pathways so your drug product remains effective and safe until application.
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Like other proteins, antibodies and antibody-related products are prone to aggregation. While the presence of a small number of aggregates may be uncritical, aggregation and the formation of protein particles indicate a stability problem or issue with the formulation. The presence of aggregates and particles may also negatively impact the therapy’s safety through unwanted immunological side effects. That’s why we include comprehensive analytical techniques during drug product development and troubleshooting.