A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum.

Immunogenicity assays are required to evaluate anti-drug antibody (ADA) responses that can be generated against biotherapeutic modalities. Regulatory guidelines focus on clinical requirements, yet it has become apparent that industry has applied these clinical recommendations for immunogenicity assessment to nonclinical studies in varying degrees. ADAs are an anticipated outcome of dosing a humanized or fully human biotherapeutic into an animal. However, a nonclinical ADA response is rarely predictive of the immunogenic potential in humans. The addendum to ICH S6 recommends that immunogenicity should be explicitly examined where there is: evidence of altered pharmacodynamic activity; unexpected changes in exposure in the absence of a pharmacodynamic marker or evidence of immuno-mediated reactions. The European Bioanalytical Forum has extensively discussed and reached a consensus on a minimal strategic approach of when and what to include for nonclinical immunogenicity assessments. Additionally, this paper recommends a strategy for ADA assay validation and sample analysis for those cases when it is considered necessary to include an immunogenicity assessment in nonclinical toxicology studies.

A Phenomenological Study of the Lived Experience of Roman Catholic Sisters and Successful Aging.

Purpose: To gain an understanding of how religious and spiritual practices might enable Catholic Sisters to age successfully. Design: A purposive sample of 12 retired Roman Catholic Sisters aged 75 years and older from two convent settings were interviewed. Method: Using a semistructured recorded interview, the Roman Catholic Sisters shared their lived experiences of aging, and practices of religion, spirituality, and meditation. Data analysis utilized thematic analysis of the interview texts. Findings: Thematic analysis identified the following themes: daily engagement in religious and spiritual practice and meditation; self-contentment and positivity regarding the meaning of successful aging; life acceptance; sense of faith and positivity regarding the afterlife; and intersection of meditation, prayer, spirituality, and cognitive engagement. Conclusion: This research contributes to the body of aging research and presents successful aging as understood and more specifically as experientially influenced. The findings of the study provided insight regarding the meaning and experience of successful aging, and the role of everyday religious and spiritual practices in the lives of the Catholic Sisters which influenced their individual life experiences as they age.

Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective.

Microsampling has the 3R benefits of refining blood collection techniques while reducing the number of animals required for rodent safety assessment studies. There are significant scientific benefits of correlating study findings with systemic exposure and consequently, there is an industry drive to utilize microsampling in regulatory toxicology studies. This article will focus on capillary microsampling and will discuss the initial considerations before using capillary microsampling, study design and some practicalities of sample collection. From a bioanalytical perspective, the impact of different sample collection and storage workflows on the design of method validation experiments, the suitability of using microsampling for unstable analytes and aspects supporting analysis of peptides, large molecules and for biomarker applications will be discussed.