Module 9 2024

03/09/2024

Hazard of biotech products

• rHu Erythropoietin (various): variations in potency

• rHu Erythropoietin (Eprex): red cell aplasia

• rHu factor VIII; suspected penicillium contamination

PEG-rHu MGDF: thrombocytopenia

•

• Gene therapy: Gelsinger, X-linked SCID trials

• mAb TGN1412: CD28 agonist, Phase 1 cytokine storm

The Organisation for Professionals in Regulatory Affairs

39

Hazard of biotech products

• rHu Erythropoietin (various): variations in potency

• rHu Erythropoietin (Eprex): red cell aplasia

• rHu factor VIII; suspected penicillium contamination

PEG-rHu MGDF: thrombocytopenia

•

• Gene therapy: Gelsinger, X-linked SCID trials

• mAb TGN1412: CD28 agonist, Phase 1 cytokine storm

The Organisation for Professionals in Regulatory Affairs

40

20