Stepwise Access to Safe Plasma Proteins in Resource-Constrained Countries: Local Production & Pathways to Fractionation
September 21-23, 2021 (daily 3-hour online sessions)
Registration is free of charge.
Organized by the Working Party for Global Blood Safety (GBS) of ISBT
The program will feature presentations by experts from international organizations and associations (WHO, WFH, IPOPI, IPFA, PPTA) and suppliers of pathogen reduction technologies & plasma processing devices and equipment.
Scope and Purpose
The workshop will identify pragmatic technical options for stepwise access to safe plasma protein therapies in resource-constrained countries to support implementation of recent WHO guidance on “Increasing Supplies of Plasma-derived Medicinal Products in Low- and Middle-income Countries through Fractionation of Domestic Plasma” and “Centralization of Blood Donation Testing and Processing.”
Topics Covered
Unmet clinical needs in safe plasma protein therapies for treatment of bleeding disorders and immunodeficiencies
Robust quality and safety criteria of plasma for fractionation and plasma derived products, including coagulation factors and immunoglobulins
Stepwise measures to avoid wasting recovered plasma and to increase availability of plasma for plasma protein manufacture
Considerations to implement a contract/toll plasma fractionation program and to address technical and financial issues
Cost considerations in plasma collection and fractionation
Interim alternatives to fractionation through local production by blood establishments of safe therapeutic plasma proteins: quarantine/retested plasma; pathogen-reduced plasma, cryo-poor plasma, and cryoprecipitate; pathogen-reduced mini-pool plasma products (cryoprecipitate, IgG, and other products)
Single-use processing for local plasma protein purification and virus inactivation
Technical solutions from the suppliers of single-use devices for local processing and virus inactivation of plasma, cryoprecipitate, cryoprecipitate poor plasma and immunoglobulins
Role of suppliers in training of personnel and local implementation of technologies
Regulatory considerations for validation of small/medium scale plasma processing
Programme