Once the original drug vial is received at Evidentic, the product undergoes a first quality control at our GDP-certified storage facility. In a second step, this quality control step is repeated at our GMP-certified aliquotation laboratory.
The product then undergoes a standardized aliquotation procedure. Following a specially designed aliquotation procedure, the therapeutic molecules are stored at the conditions as recommended by the original manufacturer or alternatively stored at -80°C.
Regular drug aliquots are used as starting material for the diluted drug aliquots (dDA) diluted to 1 mg/ml. They are diluted in our GMP-certified laboratory to a final concentration of 1.0 mg/ml. A phosphate buffered saline buffer (PBS) pH 7.4 is used as diluent. The samples contain no preservatives (NaN3) and no additional BSA. After dilution, all samples are stored and frozen at -80°C.How many milligrams of therapeutic molecule does an drug aliquot or diluted drug aliquot contain?
Most drug aliquots contain between 0.1 – 12 mg of the original drug product (RMP). The concentration of the RMP remains unchanged and the original drug buffer is also transferred during the aliquoting process. Typically, the volume of a drug aliquot is between 40 – 400 µl.For diluted drug aliquots, the concentration is fixed at 1 mg/mL, for a 0,1 mg quantity of therapeutic molecule.