Source Plasma for Further Manufacture and Transfusion Medicine – Finding Common Ground

Monday, October 21, 2024

8:15 AM - 9:15 AM

Location: 320

CE: 1 CME (AMA Physician Credit) / 1 CE (Non-Physician Credit)

Speaker(s)

TS

Toby Simon, MD (he/him/his)

Senior Medical Consultant
Self employed
Albuqerque, New Mexico, United States

Disclosure(s): CSL Behring: Consultant/Advisory Board (Ongoing)
James Knowles, PhD (he/him/his)

Senior Director, Head Global Regulatory Policy
Plasma Protein Therapeutics Association, Maryland, United States

Disclosure(s): Grifols Biomat USA: Full-time/Part-time Employee or Owner (Terminated, July 21, 2023)

Program Chair(s)

Michelle Fransen, MPH, MPS (she/her/hers)

Director, Lead for Study Management
Plasma Protein Therapeutics Association
Annapolis, Maryland, United States

Disclosure(s): No financial relationships to disclose

PDF

Disclosure(s):

Toby Simon, MD: CSL Behring: Consultant/Advisory Board (Ongoing)

James Knowles, PhD: Grifols Biomat USA: Full-time/Part-time Employee or Owner (Terminated, July 21, 2023)

Michelle Fransen, MPH, MPS: No financial relationships to disclose

Session Desription: Plasma-derived therapies (PDTs) constitute an ever-expanding segment of biotherapeutics that support or impact various transfusion medicine and therapeutic apheresis interventions. Despite many similarities in US regulatory requirements, as well as donor and collection safety issues, there is opportunity for enhanced awareness and education within transfusion medicine about Source Plasma (SP) for further manufacturing. While collection and transfusion of blood has remained largely stable in recent years, SP collection has grown from more than 18 million liters in 2010 to more than 38 million liters in 2021, a 4.9% annual growth rate, compared to 1.7 million liters of recovered plasma in 2021, a 3% annual growth rate. Globally, SP from North American donors provides more than 63% of plasma for further manufacture. This translates to more than 40 million paid US SP donations per year. Utilization of Immunoglobulin (Ig) for an increasing number of indications has largely driven demand, but many specialty products for other uses are manufactured, including all Rh-Ig used in the US.

We will introduce PDTs beginning with the invention of plasma fractionation and the field’s evolution to its current structure. Regulations, standards, and quality complexities both in and outside the US which govern plasma collection and its manufacture into product will be compared to those governing whole blood collection. Further discussion of regulatory complexities and the opportunity for collaboration between plasma and whole blood industries will be explored. Remunerated plasma donor characteristics, recent donor safety publications, and the plasmapheresis process, including donor recruitment, testing, and plasma collection practices will be outlined and compared to non-remunerated plasma donations. Common PDTs in clinical applications will also be discussed. This session, by highlighting these key elements of the plasma industry’s history and current practices, will raise awareness of the commonalities between these two different yet complementary sides of the blood component industry.

CABP CE Eligible

Learning Objectives:

Summarize the collection and manufacture of source plasma to plasma derived therapies.
Discuss the clinical applications of plasma derived therapies.
Explain the differences in regulatory complexities between whole blood and US and global plasma collections.
Compare remunerated and non-remunerated source plasma donor characteristics and safety considerations.
Describe ways the plasma and whole blood industries can collaborate in the care of patients.