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.

 

Online Workshop organized by the Working Party for Global Blood Safety (GBS)

 

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.”

 

WHO Guidances

https://www.who.int/publications/i/item/9789240021815
https://www.who.int/publications/i/item/9789240020825

 

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

Discussions

Time will be allocated for exchanges among participants.

 

Programme

Introduction and housekeeping issuesMartin 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 Prevot (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), Nicaragua - René Berrios (MINSA)

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)

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 Bonsdorf (Finland, IPFA)

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