Immunogenicity Assessment of Pegfilgrastim in Patients with Breast Cancer
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Bibliographic record
Abstract
Introduction . Neutropenia, which is an abnormally low concentration of neutrophils in the blood, is one of the common side effects in patients receiving radio- or chemotherapy. Neutropenia usually leads to higher risks of severe bacterial and fungal infections. Such medicines as colonystimulating factor filgrastim (and its conjugates) are used to prevent and treat neutropenia in oncology patients. Immunogenicity is a potential concern for any biological product, thus, its assessment is one of the most critical necessities during the development and registration of such products. Aim . The main aim of this study was to validate the ELISA method for anti-pegfilgrastim antibodies detection in human serum samples and to apply the validated method to pegfilgrastim drugs immunogenicity assessment. Materials and methods . To assess pegfilgrastim immunogenicity, the commercial ELISA kit «PEGylated Filgrastim (Neulasta®) ADA ELISA» was used for screening, confirmatory and titer assay. Moreover, to confirm the chosen commercial kit suits the study aims it was revalidated. The absorbance values were obtained using plate immunoassay analyzer Stat Fax 3200, plate washing was performed using an automatic twochannel plate washer. Results and discussion . The ELISA method for anti-pegfilgrastim antibodies determination in human serum samples was validated and applied to the analytical part of the comparative, multicenter, blind, randomized study of pegfilgrastim efficacy and safety in patients with breast cancer, receiving myelosuppressive chemotherapy. Human serum samples were first screened for anti-drug antibodies, then «screening positive» samples were analyzed in confirmatory assay with % inhibition calculation for each sample. The «confirmed positive» samples were further characterized in titer assay. Conclusions . The ELISA method for anti-pegfilgrastim antibodies determination in human serum samples was successfully validated and applied for pegfilgrastim drugs immunogenicity assessment.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it