The scope and requirements related to preclinical and clinical studies of a new medicinal product, including biotechnological and biosimilar products.

The article presents an outline of the requirements concerning the planning of preclinical and clinical studies, necessary for the legal approval of a medicinal product. It describes the clinical research plan of innovative and generic pharmaceutical products, taking into account the specific situations in which the assessment of biological equivalence of a generic product is not possible based on pharmacokinetic parameters. The article also discusses the guidelines which determine the scope of studies which are necessary in the process of registration of biotechnological and biosimilar products.

Human plasma fractionation and the impact of new technologies on the use and quality of plasma-derived products.

Recent years brought several important changes in the domain of human plasma derived products. High purity and effective anti-viral treatment became a reality. This radically improved the quality of patient treatment.

Large-scale preparation of a highly purified solvent-detergent treated factor VIII concentrate.

Large-scale adaptation of a recently reported glycine precipitation method for the production of factor VIII (FVIII) concentrate is described. Scaling up of the method required some modification including the addition of aluminum hydroxide to the glycine buffer to reduce the level of contaminating proteins in the final preparation and the use of centrifugation to replace filtration by glass beads. Furthermore, the resultant product was virus inactivated by incorporation of the organic solvent and detergent technique.

The interaction between human blood-coagulation factor VIII and von Willebrand factor. Characterization of a high-affinity binding site on factor VIII.

The interaction between human Factor VIII and immobilized multimeric von Willebrand Factor (vWF) was characterized. Equilibrium binding studies indicated the presence of multiple classes of Factor VIII-binding sites on vWF. The high-affinity binding (Kd = 2.

Modified glycine precipitation technique for the preparation of factor VIII concentrate of high purity and high stability.

A modification of the glycine precipitation method for the production of factor VIII concentrate is reported. In this procedure, cryoprecipitate was prepared, washed and dissolved in buffer. Contaminating fibrinogen was precipitated by the addition of 2.