No abstract

The biopharmaceutical industry has invested considerably in the implementation of single-use disposable bioreactors in place of or in addition to their stainless steel-counterparts. This new wave of construction materials for disposable bioprocess containers encompass a plethora of uncharacterized secondary compounds that, when in contact with the culture media, can leach, contaminating the bioprocess. One such cytotoxic leachable already receiving attention is bis(2,4-di-tert-butylphenyl)-phosphate (bDtBPP), a breakdown product of the secondary antioxidant Irgafos 168 in polyethylene-film based bags. This compound has been demonstrated to inhibit cell growth at concentrations ranging from 0.12 to 0.73 mg/L across an array of cell lines. Here we demonstrate that a further two CHO cell lines exhibit sensitivity to bDtBPP exposure at concentrations lower than that previously reported (0.035-0.1 mg/L). Furthermore, these inhibitory concentrations reflect bDtBPP levels found to leach early into the bioprocess, exposing reactor inoculums to serious risk. Quantitative label-free LC-MS/MS revealed that irrespective of cell line or concentration of bDtBPP, 8 proteins were found to be commonly differentially expressed in response to exposure to the compound highlighting biological processes related to cellular stress. Although the glycoprofile of the recombinant antibody remains primarily unchanged, we demonstrate that this compound when spiked at meaningful concentrations 72 h into culture considerably reduces the maximum cell density achieved. Studies like this reinforce the requirement for the complete characterization of all potential leachable compounds from disposable materials to assess their risk not only to the patient but also to the production pipeline itself. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1547-1558, 2016.

Using a large item pool, participant, and expert input, as well as factor and Rasch analysis, we designed a valid and reliable assessment to measure vision-related IADL performance in persons with severe vision loss. This assessment tool can be used in clinical sight restoration trials.

The O&M-VLV was designed to capture key elements of O&M performance in persons with severe vision loss, which is a population not often studied previously. Performance on these tasks was associated with both binocular visual acuity and visual field. This new protocol includes assessments of orientation, which may be of benefit in vision restoration clinical trials.

No abstract

The psychometric properties of the IMQ were promising. Our findings are useful for researchers evaluating the effectiveness of novel treatment technologies on mobility in a severely visually impaired population from the participant's perspective. However, further validation studies in larger samples are required to confirm our results.

Attachment and Biobehavioural Catch-Up" (ABC) is a 10 session home visiting program, grounded in attachment theory. It aims to improve child emotion regulation, attachment and behavioral outcomes through changing caregivers' attachment related behaviors. There is increasing evidence with respect to the effectiveness of ABC in producing positive child outcomes, but the intervention's direct effect on parent outcomes remains unclear. This review examined the association of ABC with attachment related parent outcomes. The PubMed, EMBASE, PyschINFO and SCOPUS databases were searched for relevant studies in August 2021, and again in April 2022. The eligibility criteria for included studies were (1) infants aged 0-27 months at time of the ABC intervention,(2) "at risk" parents, (3) controlled trials published in peer-reviewed journals and (4) utilized a measure of attachment related parent outcomes. Eleven eligible studies were included. The findings showed ABC had a significant small to medium effect on a variety of attachment related parent outcomes among parents presenting with multiple psychosocial risk factors. "Sensitivity" was measured most frequently, with small to medium main effect sizes recorded at follow-up, compared to controls. Implications for the clinical effectiveness of the ABC program in community settings are discussed. Future research should clarify who ABC is most effective for and how it compares to similar interventions.