Regulatory Decision Summary for SSP+

Platelet transfusion products are procured from donors either by preparation from a whole blood donation or through an automated apheresis procedure. Currently in Canada, platelets for transfusion, after their collection, are stored in the plasma of donors.

SSP+ is a platelet additive solution intended to partially replace plasma in their preparation and storage.

Platelet products are intended for transfusion, and the targeted patient population are those with blood-related disorders or cancer patients requiring platelet transfusion. There is no direct therapeutic effect to be expected from the formulation.

Since SSP+ is a solution for the storage of platelet concentrates and has no medical indications on its own, it should never be infused directly into a patient.

Leukocyte-reduced Platelet Additive Solution products are usually stored in a mix of up to 80% SSP+ / 20% plasma. These solutions enable platelets to be stored at 22°C ± 2°C, under gentle agitation, for up to 7 days following collection and according to local regulations.

Toxicology studies conducted on the SSP+ solution itself and biocompatibility testing of the leachable/extractable plastic materials from its container bag were assessed and found acceptable.

There was a sponsored study that examined the recovery and survival of platelets in plasma versus in SSP+ additive solution for 7 days, then transfused into healthy subjects. Another study compared transfusion efficiency of platelet concentrates preserved in plasma versus those in SSP+ in adult patients. In addition, four in vivo studies that investigated the transfusion efficiency of platelet concentrates (PCs) stored in SSP+/plasma mixture in patients were identified in the literature.

To date, there has been no indication that PAS solutions may be a cause for adverse reactions. All the reported adverse events were attributed to the platelet component and the residual plasma. Moreover, several randomised clinical studies of platelets prepared with PAS solutions demonstrated a reduced rate of adverse reactions compared to platelets suspended entirely in plasma.

Additionally, this additive platelet storage solution was CE certification marked in the EU since 2005 and classified as a Class III medical device in Europe. It is also marketed in a number of other countries. The evaluation of available European hemovigilance data revealed no alarming safety issues that would preclude approval of the product.