Table 3.
Statistical analysis of key stability-indicating assays for etanercept DP presentations over 1 month storage at 25°C±2°C
| Parameter | Change over 1 month (%)
|
|
|---|---|---|
| 25 mg/vial Lyo DPa | 25 and 50 mg PFS DPb | |
| HIC% peak 1 | −0.010 | 0.841 |
| HIC% peak 2 | −0.135 | −0.454 |
| HIC% peak 3 | 0.141 | −0.152 |
| SDS-PAGE Coomassie % LMW | 0.095 | 1.115 |
| SDS-PAGE Coomassie % HMW | −0.011 | 0.270 |
| SDS-PAGE Coomassie % Monomer | −0.082 | −1.110 |
| SE-HPLC % Peak A+A′ | −0.087 | −0.362 |
| SE-HPLC % Peak B | 0.087 | 0.362 |
Notes:
10 mg/vial Lyo presentation was considered to have greater stability than the 25 mg/vial Lyo presentation; therefore, statistical analysis was performed only on the 25 mg/vial Lyo presentation.
Since the 50 mg PFP encloses a single etanercept 50 mg DP solution for injection in PFS, and the PFP components do not have any contact with the DP contained in the PFS or with the needle that is preattached to the syringe, the analysis performed on the etanercept 50 mg DP PFS is considered applicable to the 50 mg PFP presentation.
Abbreviations: DP, drug product; Lyo, lyophilized powder; PFS, prefilled syringe; HIC, hydrophobic interaction chromatography; SDS-PAGE, sodium dodecyl sulfate-polyacrylamide gel electrophoresis; LMW, low molecular weight; HMW, high molecular weight; SE-HPLC, size exclusion high-performance liquid chromatography; PFP, prefilled pen.