生物分析および生物医学ジャーナル

This communication discusses the relevance of immunogenicity in preclinical trials and its importance in the development of biopharmaceuticals. The preclinical and non clinical development of Biopharmaceuticals is reviewed and discussed, with a focus on the specific regulatory requirements for the preclinical and clinical safety assessment of large molecules. Immunogenicity data obtained for Interferon and Rituximab during preclinical safety assessment studies are presented in this communication. Interferon and Rituximab are biopharmaceuticals that have been demonstrated to elicit immunogenic reactions in both preclinical animal models and clinical trials. The production of Anti-Drug Antibodies (ADAs) has several consequences on the systemic exposure and on the toxicity/ pharmacodynamic profile of a biopharmaceutical assessed in the preclinical stage. The impact must be carefully assessed especially when using the preclinical data to establish the Maximum Recommended Safe Starting Dose (MRSD) of the first clinical trials.

A study was conducted to evaluate the insecticidal activity of essential oils obtained from root, stem and leaves of Boenninghausenia albiflora (Sapindales: Rutaceae) against Black garden ant Lasius Niger L. (Hymenoptera: Formicidae). The major compounds in these essential oils were identified using gas chromatography-mass spectrometry and their insecticidal activity was tested at three concentrations i.e. 1, 5 and 10% in ethanol. All essential oils showed similar insecticidal and repellent activity at each concentration but significantly different at p≤0.05 from controls with LC50=12.35 μl, while dose dependent effect was significant with R2=0.803. It can be concluded that the three essential oils in this study have both insecticidal as well as repellent effect.