B illustrates an alternative freeze-drying cycle used for the lyophilisation of vaccine compositions comprising AS01 and antigen, as exemplified in example 2; the dotted lines delineate the process acceptable range for the freeze drying of a vaccine composition.
The initial RTS,S freeze-dried formulation used in initial trials contained lactose manufactured from bovine milk. To avoid the use of an excipient of animal origin, sucrose replaced lactose as cryoprotectant. This formulation was used in clinical trials up to the phase III efficacy studies. An increase of the sucrose content allowed reduction of the duration of the lyophilisation cycle. RTS,S phase III consistency FC lots were formulated from commercial scale RTS,S DS lots, whereas RTS,S phase III efficacy FC lots were formulated from small scale DS lots.
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