TBPP_introduction to derivatives of plasma as therapeutics

most complex human-derived proteome containing other tissue proteomes as subsets. Collected in huge amounts for protein therapeutic products. Big diversity of proteins, difficult for isolation but isolation is important. Bright spectrum of molecular masses of proteins.

classical proteins secreted by liver and intestines. Immunoglobulins: unique class of proteins because of their complexity. Long distance receptor ligands: classical hormones. Local receptor ligands: cytokines and others. Temporary passengers: lysosomal proteins. tissue leakage products: enzymes etc.. aberrant secretions: from tumours and other diseased tissues. foreign proteins: infectious organisms or parasites

Cohn method: 5 crude plasma fractions (1. fibrinogen, 2. antibodies, 5. albumin). Residual impurities depending on fractionation conditions. Subfractions: EtOH fractionation or alternate processes.

in special cases. Immunized for anti-D/tetanus/rabies for immune globulin. Screened for: CMV, measles, zoster, hepatitis A and B

more than 1/2 from US. Source Plasma: >65%, FDA-licensed, plasma obtained by apheresis, red cells returned to donor, more frequent donations possible (easier for the body to replace only the proteins, 1 donation per week/two weeks), 600-800ml plasma per donation, higher in FVIII. Recovered plasma: <35%, plasma remaining after whole blood collection used to make red cell concentrate, 450ml whole blood and max. 250ml plasma per donation, longer donor frequencies: 3 months, higher in immune globulins.

1. donor selection, 2. donation and plasma pool testing, 3. manufacturing process to reduce potential pathogens, 4. vigilance (screening)

risk goes down dramatically with each step, many factors for risk definition.

donor health, plasma safety. Diseases transmissible by blood: HIV, Hepatitis A/B/C, parvovirus B19