Two Examples of Potential LAL False Positives in Biopharmaceutical Drug Substance Manufacturing and the Insensitivity of rFC toward Suspected Beta Glucans from Cellulosic Filter Material
| Sample | Site 1 LAL Result (EU/mL) | Site 2 LAL Result (EU/mL) | rFC (EU/mL) | GB Buffer +LAL (EU/mL) | PTS™ (beta glucan pg/mL) |
|---|---|---|---|---|---|
| 1 | 0.141 | 0.0946 | <0.08 | <0.04 | 2265 |
| 2 | 0.12 | 0.0712 | <0.04 | <0.04 | 1254 |
| 3 | 0.105 | 0.0748 | <0.02 | <0.04 | 970 |
| 4 | 0.132 | 0.157 | <0.02 | <0.08 | 3173 |
| 5 | 0.176 | 0.109 | <0.04 | <0.08 | 2798 |
| LRW Negative Control | Below detection limit | <10 | |||
| 1 | 0.737 | 0.187 | <0.100 | <0.500 | 1379 |
| 2 | 0.681 | 0.171 | <0.100 | <0.500 | 1382 |
| 3 | 0.669 | 0.134 | <0.100 | <0.500 | 1076 |
LRW, LAL reagent water; GB Buffer, glucan blocking buffer.