Workshop Stepwise Access to Safe Plasma Proteins in Resource-Constrained Countries: Local Production & Pathways to Fractionation

Introduction and housekeeping issues: Martin Smid (The Netherlands, Chair of the ISBT Global Blood Safety Working Party) 
Welcome from ISBT: Erica Wood (Australia, ISBT President)

Moderators:    Jean-Claude Faber (Luxembourg – ISBT WP GBS) and Cesar Garrido (Venezuela - WFH)

13:10-13:30    Coagulation factors (FVIII, VWF, FIX, PCC, fibrinogen, others) - Saliou Diop (Senegal, WFH)

13:30-13:50    Immunoglobulins (polyvalent) - Johan Prévot (Belgium, IPOPI)

13:50-14:05    Discussion/Q&A

Moderators:   Thierry Burnouf (Taiwan, ISBT GBS WP) and Junping Yu (Geneva, WHO)

14:05-14:25    Wastage of plasma in LMIC - Yuyun Maryuningsih (Geneva, WHO)

14:25-14:45    Key steps to improve quality of plasma for further processing - Vee Armstrong (Australia)

14:45-15:05    Plasma fractionation technologies: benefits and limitations; technical issues - Jan Bult (The Netherlands, PPTA)

15:05-15:25    Oversight of contract plasma fractionation - Françoise Rossi (France, IPFA)

15:25-15:45    Country experiences: Thailand - Narin Kijkriengkraikul (Thai Red Cross), Argentina - Andrea Corina Zucchi (UNC)

15:45-16:00    Discussion/Q&A

Moderators:    Jean-Claude Faber (Luxembourg, ISBT GBS WP) and Jay Epstein (USA, ISBT GBS WP)

13:00-13:20    Recruitment and retention of safe Donors Giuliano Grazzini (Italy, FIODS)

13:20-13:40    Quarantine of plasma as a means to reduce the risk of transfusion-transmitted infection: logistics and feasibility Pierre Tiberghien (France, EFS)

13:40-15:20    Technologies for pathogen reduction (PR) of single-donor or mini-pools of plasma, cryoprecipitate, and immunoglobulins: experience from suppliers and users:

• Strategies to move safe plasma products into low resource areas: overview and experience with Riboflavin/UV Jeffrey McCullough (USA)
• Psoralen/UVA Hans Vermeij (Brazil, Cerus)
• Methylene blue/light Stefan Reichenberg (Germany, Macopharma)
• Pathogen reduction of COVID-19 convalescent plasma Salwa Hindawi (Saudi Arabia, King Abdulaziz University)     
• Mini-pool solvent/detergent of plasma, cryoprecipitate & caprylic acid fractionation of immunoglobulins (VIPS) Magdy El-Ekiaby (Egypt, Shabrawishi Hospital)

15:20-15:40    Viral safety of plasma derived components Johannes Bluemel (Germany, PEI)

15:40-16:00    Discussion/Q&A

Moderators:    Micha Nuebling (Germany, WHO/PEI) and Thierry Burnouf (Taiwan, ISBT GBS WP)

13:00-13:15    Potential contribution of single-use technologies for processing domestic plasma components Prity Bengani-Lutz (USA, Sartorius)

13:15-13:30    Domestic scalable plasma processing: technological approaches and solutions for LMIC Josephine Cheng (Taiwan, Merck Millipore) and Jian-Fei Shou (China, Merck Millipore)

13:30-13:45    Potential contribution of nanofiltration to the virus safety of domestic plasma components Tomoko Hongo-Hirasaki (Japan, Asahi Kasei Medical)

13:45-14:00    SARS-CoV-2 immunoglobulins in India as an example for domestic production of immunoglobulins: Safety, efficacy and quality attributes Suma Ray (India, Intas Pharmaceuticals)

14:00-14:20    Plasma fractionation of animal-derived immunoglobulins in LMIC: lessons to be learned for human plasma IgG production Mariángela Vargas (Costa Rica, Instituto Clodomiro Picado)

14:20-14:40    Regulatory considerations for authorization of plasma processing devices: example of an EU CE marking Mohamed Ghonim (Switzerland, QSE Consulting) 

14:40-15:00    Discussion/Q&A

Moderators:    Martin Smid (The Netherlands, ISBT GBS WP) and Jay Epstein (USA, ISBT GBS WP)

15:00-15:20    Models for technology transfer and technical assistance Leni von Bonsdorff (Finland, IPFA)

15:20-16:00    Panel discussion: Lessons learned and next steps Yuyun Maryuningsih (WHO), Giuliano Grazzini (FIODS), Cesar Garrido (WFH), Saliou Diop (WFH), Johan Prevot (IPOPI), Johannes Bluemel (PEI), Leni von Bonsdorff, (IPFA), Jan Bult (PPTA)