Current status and trends in blood biologicals / 生物工程学报

ABSTRACT

Blood products are those biologicals derived from plasma or obtained by recombinant technologies. This overview covers the characteristics and classification of plasma proteins, the current status of products (albumin, immunoglobulins, coagulation factors and microcontent proteins), as well as the likely trends in the near future. Human serum albumin is one of the earliest, safest and most widely used proteins in the pharmaceutical field. The approval and development of high-purity plasma albumin, recombinant human albumin and HSA fusion proteins provide a favorable prospect for the therapeutic protein. Normal immunoglobulin contains antibodies to all the micro-organisms prevalent in the donor population. The IMIG is relatively simple to prepare and use, and the side effects are acceptable; IVIG is used mainly to treat patients with primary immunodeficiency syndromes; SCIG preparations can be used in selecting suitable patients for home therapy and have occurred fewer adverse systemic reactions; specific immunoglobulins contain concentrations of antibody to an individual organism or toxin at a higher titer than normal immunoglobulin and can not be replaced in clinical use. The plasma-derived or recombinant coagulation factors are used to treat the patients with congenital or acquired factor deficiency. The products such as Fibrinogen, FVII, FVIII, von Willebrand complex, FIX/PCC, FXI, FXIII and so on, have been widely used and proved to be effective. The development of recombinant FVIIa is now as a good bypassing product to haemophilia with inhibitors. The Fibrinogen and thrombin play a very important role in surgery hemostasis. Moreover, microcontent proteins including protein C, antithrombin, alpha 1-AT, tPA have been licensed and used in clinical treatment; a number of other small field proteins are under produced research or pre-clinical investment. The ongoing development of new recombinant plasma proteins is providing alternatives for patients, but the distinct position and the potential impact of plasma-derived preparations are unique, furthermore the development of new plasma protein is still a hot spot in global pharmaceutics. Nowadays, a relative difference exists in the development of blood products between our nation and developed countries, so the domestic manufacturers are faced with chances and challenges.