Anti-CR1 monoclonal antibody, clone Cds-NBD-ESD

Beckground: Severe early childhood caries (S-ECC) is a form of dental caries which is very destructive in early childhood since involving several teeth, include the maxillary anterior teeth. Streptococcus mutans (S. mutans) play an etiological integral role of ECC so that S. mutans are considered as the predictor of dental caries. The neutrophil is a key component of the rst line of defense against microbial invasion. The essential function of neutrophil is to kill pathogenic microbes through a phagocytosis process which is mediated by Complement Receptor 1 (CR1)/ (CD35(+)). Aims and Objectives: To analyze the phagocytosis process of the salivary neutrophil which is mediated by innate immunity component, i.e., Complement Receptor 1/CR1 (CD35) on S-ECC. Materials and Methods: his study was an observational analysis with cross-sectional approach using t-test analysis. This study employed the isolation steps of neutrophils saliva of caries-free children and the S-ECC and then conducted phagocytosis of salivary neutrophils test on S. mutans mediated by CD35 using ow cytometry. Results: Phagocytosis of salivary neutrophils on S. mutans mediated by CD35 on caries-free (2.35 +/- 0.56) is higher than that on the S-ECC (1.54 +/- 0.35). Conclusions: It is concluded that there is a decrease of phagocytic on S. mutans mediated by Complement Receptor 1/CR1 (CD35(+)) on S-ECC.

Background E6011, a humanized antifractalkine monoclonal antibody, is under development for the treatment of various inflammatory diseases, such as rheumatoid arthritis. A reproducible assay method has been developed for the determination of E6011 in monkey and human serum by electrochemiluminescence (ECL) assay. Methods E6011 in serum was captured by fractalkine and detected by ruthenium-labeled rabbit anti-E6011 Fab polyclonal antibodies for ECL detection. E6011 in serum was quantifiable from 0.02 and 0.1 mu g/mL in monkey and human serum, respectively, with minimum required dilution of 500. The method was then validated in accordance with bioanalytical guidelines. Results Accuracy and precision of quality control samples at five concentrations in intra- and interbatch reproducibility demonstrated that relative error and relative standard deviation were within acceptable criteria. Recovery of E6011 was 92.9%-121.7% and 85.0%-109.3% in humans and monkeys. Dilution integrity, no prozone effects, and no impacts by antigen were also ensured. Parallelism was also confirmed using incurred clinical sample analysis. Various types of stability were assessed, which confirmed that E6011 in serum was stable for 367 and 735 days in monkey and human sera, respectively, under frozen conditions. Conclusion The developed method was successfully applied supporting pharmacokinetic studies in monkeys and humans.