Table 3.
Description of Sample and the Corresponding In-Process Assay
| Sample No. | Sample Description | In-Process Assay |
|---|---|---|
| 1–10 | passages 1–10 | pH, glucose, lactate |
| 11 | limit of in vitro cell age for production | N/A |
| 12 | unprocessed bulk day 3 PI | sterility, pH, glucose, lactate, ED7R titer |
| 13 | unprocessed bulk day 4 PI | sterility, pH, glucose, lactate, ED7R titer |
| 14 | unprocessed bulk day 5 PI | sterility, pH, glucose, lactate, ED7R titer |
| 15 | pooled unprocessed bulk | N/A |
| 16 | Mustang Q load | ED7R titer |
| 17 | equilibration of Mustang Q | pH and endotoxin |
| 18 | Mustang Q flowthrough | ED7R titer |
| 19 | Mustang Q wash | ED7R titer |
| 20 | Mustang Q elution fraction | ED7R titer |
| 21 | diluted Mustang Q elution fraction | ED7R titer |
| 22 | TFF membrane equilibration | pH and endotoxin |
| 23 | Opticap XL-2, 0.22-μm filter | bubble point test |
| 24 | drug substance | ED7R titer |
| 25 | drug product | 100% weight check |
TFF, tangential flow filtration; PI, post induction; N/A, not applicable.