Survey Results of Historical Bioburden Control Concerns in Biopharma
| Is bioburden a concern for affinity capture processing? | Ten of the 12 respondents consider the affinity capture step to be susceptible to microbial ingress and/or colonization. |
| What are the inherent factors which drive this concern? | 1. Potential presence of nutrients in the charge and buffer solutions to support proliferation. |
| 2. Packing and unpacking are open operations. | |
| 3. Storage solutions with limited bactericidal efficacy. | |
| 4. Limited sanitization options for resin type. | |
| 5. Potential for niche spaces in columns which may not be exposed to sanitization (i.e., difficult-to-clean areas). | |
| 6. Difficult-to-eliminate potential microbial contamination following ingress. | |
| Historical experience with bioburden during processing | Two of 12 respondents have not observed significant bioburden issues and/or special concerns compared to other chromatography steps. |
| All 12 respondents have experienced a bioburden issue historically. These vary from a low-level isolated event to a recurring event. |