The Comparability of rFC and LAL in the Absence and Presence of Endotoxin Analyte across 18 Pharmaceutical Products and Excipients
| Sample Type | Result Comparability | Positive Control Comparability | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| LAL Result Lot 1 | LAL Result Lot 2 | LAL Result Lot 3 | rFC Result Lot 1 | rFC Result Lot 2 | rFC Result Lot 3 | LAL %PPC Average | LAL %PPC %CV | rFC %PPC Average | rFC %PPC %CV | |
| Insulin Solution | <60 | <60 | <60 | <20 | <20 | <20 | 110% | 7% | 96% | 6% |
| Insulin Suspension | <60 | <60 | <60 | <20 | <20 | <20 | 110% | 9% | 98% | 3% |
| Insulin Suspension | <20 | <60 | <20 | <20 | <20 | <20 | 105% | 8% | 91% | 2% |
| MAb DS | <0.01 | <0.01 | <0.01 | <0.01 | <0.01 | <0.01 | 144% | 7% | 97% | 2% |
| MAb DP | <0.00883 | <0.0100 | <0.0200 | <0.0042 | <0.0042 | <0.0042 | 74% | 12% | 101% | 4% |
| MAb DS | <0.01 | <0.01 | <0.01 | <0.06 | <0.05 | <0.06 | 84% | 17% | 94% | 1% |
| MAb DP | <0.02 | <0.02 | <0.02 | <0.05 | <0.05 | <0.05 | 120% | 6% | 88% | 8% |
| MAb DS | <1.2 | <1.2 | <1.2 | <0.0250 | <0.0244 | <0.0244 | 106% | 5% | 92% | 3% |
| MAb DP | <0.6200 | NT | <0.6250 | <0.167 | <0.167 | <0.167 | 110% | 32% | 105% | 7% |
| MAb DP | <0.0200 | <0.0200 | <0.0200 | <0.0500 | <0.0500 | <0.0500 | 108% | 14% | 107% | 0% |
| MAb DS | <0.01 | <0.01 | <0.01 | <0.0329 | <0.0329 | <0.0294 | 138% | 11% | 100% | 2% |
| MAb DP | <0.0125 | <0.0125 | <0.0125 | <0.03125 | <0.03125 | <0.03125 | 114% | 13% | 109% | 7% |
| MAb DP | <0.0025 | <0.0025 | <0.0025 | <0.025 | <0.025 | <0.025 | 93% | 22% | 100% | 6% |
| MAb DS | <0.01262 | <0.01267 | <0.01291 | <0.00315 | <0.00317 | <0.00323 | 151% | 23% | 94% | 3% |
| MAb DP | <0.0050 | <0.0050 | <0.0050 | <0.025 | <0.025 | <0.025 | 103% | 13% | 99% | 3% |
| MAb DS | <0.1 | <0.1 | <0.1 | <0.00669 | <0.00656 | <0.00656 | 74% | 14% | 111% | 1% |
| Excipient | 0.0106 | <0.0025 | <0.0025 | <0.01 | <0.01 | <0.01 | 100% | 39% | 117% | 2% |
| Excipient | <0.005 | <0.005 | <0.005 | <0.01 | <0.01 | <0.01 | 109% | 6% | 92% | 3% |
| Water: rFC Supplier 11 | <0.05003 | <0.0500 | <0.0500 | <0.0500 | 112%3 | 12%3 | 106% | 11% | ||
| Water: rFC Supplier 21 | NT | <0.0500 | <0.0500 | <0.0500 | NT | NT | 89% | 1% | ||
| Water: rFC Supplier 12 | NT | <0.0100 | <0.0100 | <0.0100 | NT | NT | 96% | 8% | ||
| Average | 108% | 19% | 99% | 8% | ||||||
↵1 0.05 EU/mL assay sensitivity.
↵2 0.01 EU/mL assay sensitivity.
↵3 Samples comprised of 88 discrete samples.
Insulin sample type result units are EU/100U; Water result units are EU/mL; all others are EU/mg; %PPC criteria is 50–200% per compendia.
NT, not tested; DS, drug substance; DP, drug product; %PPC, product positive control recovery (%).