Risk Analysis with Cell Therapy Products Related to Input Materials—Donor Selection and Cell Collection
| Input Materials | Risk Identification | Risk Rating | Risk Mitigation/Critical Process Controls |
|---|---|---|---|
| Donor qualification | Autologous donation | Low | Donor interview; Medical examination |
| Allogeneic donation | Moderate to High | Donor interview; Medical examination; Infectious agent screening | |
| Source of the cells | Peripheral blood | Lowa | Skin sanitization; Diversion of the first 10 mL during collection |
| Adipose tissue | Moderate to High | Surgical suite | |
| Bone marrow | High | Surgical suite | |
| Cord blood | Moderate | Maternal risk screening; Vaginal birth; Use of cord retrieval technicians | |
| Collection process | Systems with a high probability of microbial ingress | High | Eliminate “open” systems |
| Systems with a low probability of microbial ingress | Low | Promote “closed” systems |
↵a May be high if the patient has a preexisting microbial infection.