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Cytokine Release Assay Based on Whole Blood Samples
Antibody Stability Assay Based on Serum Samples: serum, as a sample matrix that more closely resembles the human microenvironment, is one of the ideal choices for in vitro drug stability evaluation. Serum contains a variety of hydrolases; if the compound under investigation has affinity for one of these enzymes and carries a hydrolyzable group at an appropriate position, the compound can be degraded in serum, thereby compromising the accuracy of bioassay results or preventing it from reaching an effective therapeutic concentration in vivo. Leveraging its strengths in clinically characterized sample resources, SailyBio provides in vitro stability testing for drug candidates.
Industrialized cell isolation and preparation workflows with full-process quality control management; stable and compliant immune cell sourcing that shortens experimental cycles and ensures consistency of conclusions; access to a donor pool of more than 2,000 donors, enabling pre-screening of donors with stronger immune responses to accelerate development and reduce R&D costs; safe and compliant project services that satisfy the documentation requirements for new drug application regulatory submissions; and customized services tailored to client needs with guaranteed delivery timelines.
Service Scope (Developability Assessment):
• Efficacy Evaluation (whole blood, serum): flow cytometry screening, cell killing, cellular internalization, proliferation inhibition, cytokine detection, ELISPOT cellular immune response assay, enzyme activity assay, etc.
• Safety Evaluation (whole blood, serum): cytokine release, FACS binding assay, etc.
• Stability Evaluation (whole blood, serum): binding ELISA, half-life and degradation rate assays
SailyBio provides customized in vitro efficacy evaluation services based on whole blood/serum samples, covering modules such as whole blood efficacy evaluation, serum antibody stability assays, and CD bispecific antibody binding assays, meeting the full-process developability assessment requirements of small-molecule, antibody, and vaccine drug candidates.
Antibody Stability Assay Based on Serum Samples: the drug molecule under test is incubated in serum for a defined period of time, after which its intrinsic properties are assessed. As determined by a binding FACS assay, the test antibody remains stable in serum for at least 14 days.
Figure: Schematic illustration of whole blood sample-related assays
Figure: Cytokine release assay data from whole blood samples
Figure: Antibody stability assay data in serum samples
Small-molecule drugs, antibody therapeutics, immunomodulators, and vaccines can all undergo pharmacodynamic evaluation, either directly or through surrogate biomarkers, by using specific cell subsets or components present in human whole blood. SailyBio provides customized services using whole blood samples in accordance with client requirements, ensuring both sample timeliness and assay stability.
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