At Creative Biolabs, we are well-aware of the challenges of biopharmaceuticals development and the opportunities for non-IgG therapeutic antibodies development. Our rich experience and expertise in pharmacokinetics/pharmacodynamics (PK/PD) evaluation and customized solutions will help you get the useful information you need about your therapeutic antibody. With the advent of novel technologies, considerable advances have been made at Creative Biolabs in terms of PK/PD evaluation.
Why PK/PD Evaluation of mAbs Is Needed?
PK is an approach of exploring the mechanism through which organism affects a drug, while, PD aims to analyze the process that drug functions and affects the organism, both of which are of great importance in drug discovery and development, even in clinical applications. Therapeutic monoclonal antibodies (mAbs) are quite an important class of bioactive molecules with complex pharmacology and interdependent PK/PD properties. Compared to other small pharmaceutical molecules, mAbs have the advantages of high specificity, targeting, and low side effects, etc. Definitely, the structures, unique characteristics, and function modes of mAbs make their PK/PD evaluations different, which are more complex. Additionally, non-IgG therapeutic antibodies are a new class of biomolecules with tremendous therapeutic potential against various diseases, especially for tumors. Compared to widely utilized monoclonal IgG antibodies, their PK/PD tests are similar but also different. Meanwhile, understanding the PK/PD of mAbs and their biological and mechanistic underpinnings are crucial to their design and selection, evaluating appropriate efficacy and toxicity studies, translating PK/PD parameters to humans, and optimizing dose and regimen to maximize success in the clinic.
Fig.1 The alignment of major PK/PD-related studies with the decision points of mAb development in both objectives and recommended studies. (Ovacik, 2018)
PK/PD Evaluation of Non-IgG Antibodies at Creative Biolabs
As expected, non-IgG antibodies and their drug conjugates exhibit dramatic therapeutic effects on a number of Non-IgG Antibody Application for Disease Therapy with favorable characteristics, such as high selectivity and specificity, good stability, special anatomical site targeting, etc. Creative Biolabs conducts PK/PD assays to analyze and evaluate therapeutic non-IgG antibodies immediately after they are produced, purified and characterized by our comprehensive technique platform. Integrally understanding PK/PD characteristics of non-IgG therapeutic antibodies, including exposure of action site, target occupancy, and performance of pharmacological activity, is of great significance in improving the success for further applications.
We evaluate the PK/PD of therapeutic non-IgG antibodies provided by customers or produced by us, either via model-dependent or independent analysis. Available animal models in our company extensively comprise rodents, non-human primates, dogs, and so forth. Our well-constructed non-IgG antibodies technique platform will successfully accomplish your evaluation of PK/PD characteristics, which mainly include but are not limited to:
- Antibody absorption
- Dose proportionality
- Translation PK/PD across species
- Prediction of human PK/PD
Fig.2 Framework for translation of PK/PD of mAbs from in vitro and animal data to humans. (Kamath, 2016)
Fig.3 Strategy for predicting human PK. (Lavé, 2007)
Creative Biolabs offers ligand binding assays (LBA), enzyme-linked immunosorbent assay (ELISA), or electrochemiluminescence assay (ECLA) to analyze samples, to develop and validate assays to measure blood concentrations of non-IgG therapeutic antibodies. In addition, we can also evaluate the PD of biopharmaceuticals by developing analytical methods specific to the characteristics of the drug, such as the receptor occupancy of antibody drugs. If you are interested in our PK/PD characterization services, please contact us for more information.
- Ovacik, M.; Lin, K. Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development. Clinical and Translation Science. 2018, 11(6): 540-552.
- Kamath, A.V. Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies. Drug Discovery Today: Technologies. 2016, 21: 75-83.
- Lavé, T.; et al. Challenges and opportunities with modeling and simulation in drug discovery and drug development. Xenobiotica. 2007, 37(10-11): 1295-1310.
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