Biosorption of process-equipment-related leachables (PERLs) in biomanufacturing: A quantitative approach to study partitioning of PERLs in a cell culture system.

The assessment and potential risk of process equipment-related leachables (PERLs) in the production of biopharmaceuticals and cell therapeutics using single-use (SU) equipment has been discussed previously. However, potential interactions of cells with PERLs have not yet been considered. Here, we present a quantitative adsorption study of neutral, organic small-molecule leachable compounds - known for extractables & leachables (E&L) analysis of SU equipment - in aqueous suspensions of CHO and T cells. The solid-water partition coefficient Kd was obtained for all compounds that showed adsorption. The findings implied that hydrophobic interactions are dominant; however, there was no unambiguous correlation between the derived adsorption coefficient Kd and the octanol-water partition coefficient Kow. Interestingly, a maximum affinity of both cell types to the leachable bis(2,4-di-tert-butylphenyl)phosphate, which is known to be detrimental to cell development, was observed. A comparison of both cell types revealed that they generally interact with the same compounds in most cases but to different extents. Using partition coefficients enables estimation of the concentrations of leachable compounds associated with the biomass phase and in the aqueous suspensions and could be used for risk assessment of SU systems in biopharmaceutical and cell therapy (CT) manufacturing processes.

[Investigations on the influence of different mouth and nose protection masks on the evidential breath alcohol measurement]. / Untersuchungen zum Einfluss verschiedener Mund-Nase-Schutzmasken auf die beweissichere Atemalkoholmessung.

On the occasion of a judicial expert opinion on the question of whether wearing a face mask can lead to a falsification of the breath alcohol value leading to detriment of the accused, an experimental series of tests was carried out under pandemic conditions on six healthy test subjects (four men, two women), who practiced low-risk recreational alcohol consumption. On each day of the study one specific mask type (surgical mask, textile mask, FFP2 mask) was examined. After ingestion of an individually calculated amount of alcohol and a 30-min absorption phase, 6 consecutive breath alcohol measurements were carried out at 30-min intervals, with one mask or no mask worn between measurements. Subsequently, pairs of values for periods with and without a mask were formed and the hourly breath alcohol elimination rates were calculated. As a result, the breath alcohol elimination rates with and without masks did not differ from each other. There were no error messages from the breathalyzer that can be attributed to the previous wearing of a mask.

Inpatient and outpatient cocaine abusers: clinical comparisons at intake and one-year follow-up.

Given controversy about the comparative utility of inpatient and outpatient treatment for substance abusers, we compared samples of cocaine-abusing inpatients (n = 149) and outpatients (n = 149) regarding a range of clinical characteristics both at entrance into treatment and one year following this initial assessment. We wished to assess (a) whether inpatient treatment appeared justified on the basis of more severe clinical problems in this group of patients and (b) the comparative one-year outcome of patients treated in the two conditions. Regarding the presenting clinical picture, inpatients had more severe ratings in numerous areas, with heavier drug use, social impairment, and psychopathology. At one-year follow-up, the direction of clinical ratings had reversed in the two groups, with inpatients showing lower problem severity in several areas, particularly cocaine use and psychopathology. Thus, results of this nonrandomized study of inpatient and outpatient treatment suggest that decisions to hospitalize were made on a rational basis and that inpatient treatment had better long-term efficacy.

Psychiatric diagnoses of treatment-seeking cocaine abusers.

In a sample of 298 cocaine abusers seeking inpatient (n = 149) or outpatient (n = 149) treatment, rates of psychiatric disorders were determined by means of the Schedule for Affective Disorders and Research Diagnostic Criteria. Overall, 55.7% met current and 73.5% met lifetime criteria for a psychiatric disorder other than a substance use disorder. In common with previous reports from clinical samples of cocaine abusers, these overall rates were largely accounted for by major depression, minor bipolar conditions (eg, hypomania, cyclothymic personality), anxiety disorders, antisocial personality, and history of childhood attention deficit disorder. Affective disorders and alcoholism usually followed the onset of drug abuse, while anxiety disorders, antisocial personality, and attention deficit disorder typically preceded drug abuse.