Social determinants and mental health needs of Palestine refugees and UNRWA responses in Gaza during the COVID-19 pandemic: a qualitative assessment.

Background: Due to pre-existing difficulties, refugees are especially susceptible to the negative effects of the pandemic; nonetheless, the pandemic's effect on this group is still unclear. The purpose of this study was to determine the effects of the COVID-19 pandemic on the mental health of Palestine refugees in Gaza by identifying the role of social determinants. During the pandemic, the United Nations Relief and Works Agency for Palestine Refugees in the Near East (UNRWA) enacted a number of policies and measures.

Allogeneic somatic cell therapy: process development challenges and future opportunities.

Cell-replacement therapy has emerged during the past decade as a potential solution for many diseases. However, for this promise to be fulfilled, numerous process development challenges specific to these products need to be overcome. This editorial overview highlights some key observations derived from research on an allogeneic somatic cell therapy product for the treatment of Parkinson's disease.

Development of parallel line analysis criteria for recombinant adenovirus potency assay and definition of a unit of potency.

Parameter settings of a parallel line analysis procedure were defined by applying statistical analysis procedures to the absorbance data from a cell-based potency bioassay for a recombinant adenovirus, Adenovirus 5 Fibroblast Growth Factor-4 (Ad5FGF-4). The parallel line analysis was performed with a commercially available software, PLA 1.2.

Proteomic analysis for the assessment of different lots of fetal bovine serum as a raw material for cell culture. Part IV. Application of proteomics to the manufacture of biological drugs.

Fetal bovine serum (FBS) is the most widely used growth supplement for cell cultures, primarily because of its high levels of growth stimulatory factors and low levels of growth inhibitory factors. Maintaining successful and consistent cell fermentations can be difficult, as FBS is a complex natural product and may vary from lot to lot even from a single manufacturer. The quality and concentration of both bulk and specific proteins can affect cell growth.

A potency assay for a replication incompetent adenovirus type 5 carrying a human fgf-4 gene.

A bioassay that measures the potency of the FGF-4 transgene carried by a replication incompetent adenovirus type 5, Ad5FGF-4, was developed on ARPE-19 cells. The assay is carried out in a microtiter plate format and measures cellular proliferation following infection of ARPE-19 cells with a serial dilution of Ad5FGF-4. Proliferation is measured as a percentage increase in absorbance reading in relation to a mock-infected control.

Common structure of rare replication-deficient E1-positive particles in adenoviral vector batches.

The use of the PER.C6 adenovirus packaging cell line in combination with a designated vector plasmid system, whereby the cell line and vector with E1 deleted have no sequence overlap, eliminates the generation of replication-competent adenovirus during vector production. However, we have found cytopathic effect (CPE)-inducing particles in 2 out of more than 40 large-scale manufacturing lots produced in PER.