The MANCO consortium is developing monoclonal antibodies against 2019-nCoV. As one of the consortium partners CR2O BV will coordinate the phase I clinical trial and is in charge for the selection of the vendor responsible for the fill and finish process of the mAbs according to cGMP.
Please use your default fill and finish process (e.g. handfill) with the following assumptions:
— three different concentrations and placebo will be provided;
— a total of 200 to 1 000 vials are expected;
— fill vials aseptic with 0.5 mL;
— storage 4 ºC;
— standard release tests (e.g. endotoxin testing, sterility, etc.);
— labelling and packaging.
Fill and finish activities are expected to start in Jan/Feb 2022. The preparation time (if necessary) for the required activities should also be taken into consideration.