In-use stability of ready-to-administer daratumumab subcutaneous injection solution in plastic syringes.

Objective: In multiple myeloma patients, daratumumab is preferably injected subcutaneously. The summary of product characteristics of daratumumab subcutaneous injection solution specifies physicochemical stability for the prepared syringe for 24 hours at 2-8°C protected from light, and another 12 hours at room temperature (15-25°C) in ambient light conditions. The aim of this study was to determine the in-use stability of ready-to-administer daratumumab subcutaneous injection solution in different types of syringe and different conditions over a 28-day period.

Quality Control of Personalized Drug Products - Identity and Quantity of Monoclonal Antibodies as Active Pharmaceutical Ingredient.

Deliberate underdosing occurred in personalized preparations of drugs such as monoclonal antibodies as the active pharmaceutical ingredient in the past. To ensure the required quality standard and to prevent future fraud attempts at an early stage, a HPLC-DAD-HRMS method was established. Thereby, identity and quantity of the active ingredients bevacizumab, rituximab and trastuzumab were determined.

Pollutant load and ecotoxicological effects of sediment from stormwater retention basins to receiving surface water on Lumbriculus variegatus.

The overflow of stormwater retention basins during intense and prolonged precipitation events may result in the direct input of particulate pollutants and remobilization of already sedimented particle-bound pollutants to receiving freshwater bodies. Particle-bound pollutants may cause adverse effects on aquatic biota, particularly sediment dwellers. Therefore, we investigated the sediment pollution load of a stream connected to the outfalls of two stormwater basins to determine the impact of the basins' discharges on the metal and organic pollutant content of the sediment.

Development and validation of a method for airborne monoclonal antibodies to quantify workplace exposure.

Modern therapy strategies are based on patient-specific treatment where the drug and dose are optimally adapted to the patient's needs. In recent drugs, monoclonal antibodies (mAbs) are increasingly used as active ingredients. Their patient-specific formulations are not part of the pharmaceutical industry's manufacturing process but are prepared from concentrates by pharmaceutical personnel.