Chapter 12 – Blood Products

Products from human blood were among the earliest biologics developed as drugs for human therapy. Since the approval of the first recombinant factor VIII (rFVIII) in 1992, they also include recombinant biotechnologies-derived products, as well as blood and plasma for transfusion and biotherapeutics purified from human blood (e.g. immunoglobulins, coagulation factors, hyperimmune products, or antitoxins). During the last 25 years new generations of plasma-derived and recombinant coagulation factors and other recombinant hemostatic agents have addressed the need for more pure proteins and improved therapies. The nature and composition of the nonclinical drug development plan can vary greatly for biologics in general, and blood products are no exception. A key difference between plasma protein-derived therapies and other biologics is that multiple interdependent products are manufactured from a single starting material. The complex and multifaceted nature, as well as the human origin of this starting material, makes the need for emphasis on pathogen safety and viral inactivation a key focus for both the industry and regulatory agencies. Recombinant blood proteins may follow nonclinical development plans comparable to other recombinant proteins based in ICH S6(R1) and ICH S3(R2).