Paul W. Eldridge, Ph.D.

Dr. Eldridge has over 40 years of experience in immunology and cellular therapy fields. Roles have included Laboratory Director in clinical and research cellular therapy facilities at academic medical centers including most recently as Research Professor and Facility Director at Levine Cancer Institute | Atrium Health. Scope of activity has included oversight and management of manufacturing of minimal and more-than-minimal manipulated products for standard of care and research applications in hematopoietic cell transplantation and immune effector cell therapy. Product types include HPC, Apheresis, HPC, Bone Marrow, T cell, Apheresis, CAR-T, NK cells, and CAR-NK cells, mesenchymal stromal cells (MSC), gene modified hematopoietic cells and pancreatic islet cells.

Experience includes multiple projects involving laboratory renovation and construction.

Professional activity has included FACT inspector (since 1995), FACT Board member, past-Chair FACT Standards Committee. Additional service involves ISCT (Chair, North America Region; Board member; Co-Chair 2015 Annual Meeting), ASTCT, AABB Standards Committee, Co-chair- WBMT Graft Processing & Cell Therapy Committee, and AABB HCT/P Circular of Information Task Force.

Areas of Expertise

Technical expertise in cell processing, cell separation, and cell culture. Knowledgeable in regulatory compliance, quality management, Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) compliance, standards development, audits, SOP/Policy development, clinical trial and IND development, qualification and validation practices, and laboratory design and construction (including classified spaces).

Scope of Experience

35 years working as laboratory director for cell processing field in clinical service and research facilities at academic medical centers. Professional service as FACT inspector since 1995 and participation in standards development with multiple groups (FACT, AABB, WBMT).

Market Sector Focus

Hematopoietic stem cell collection and processing (bone marrow, apheresis products and cord blood) for standard of care and research therapies.
Cellular collection and processing for novel indications, clinical trials
Onboarding licensed and investigational cellular therapy products.

Relevant Assignments

Performed 30 FACT inspections of minimal and more-than-minimal processing laboratories
Former Chair ISCT North America Region
Past Chair FACT Standards Committee
Member, FACT Accreditation Committee
Former Member of FACT Board of Directors
Past Co-chair, WBMT Graft Processing and Cell Therapy Committee
Former member, AABB HCT/P Circular of Information Task Force