Table 2.
The impact of serum-like redox conditions on incorrect disulfide bridging and potency.
| Sample (batch number) | % C78–C88 (untreated) | % C78–C88 (redox) | % Potency (untreated) | % Potency (redox) |
|---|---|---|---|---|
| GP2015 DP (30986553) | 1.2 | 1.5 | 98 | 103 |
| GP2015 DP (30986557) | 1.8 | 1.3 | 97 | 101 |
| GP2015 DP (31161503) | 1.2 | 1.7 | 100 | 98 |
| GP2015 DS (B280815) | 1.0 | 1.2 | 99 | 103 |
| Enbrel® (J13793) | 2.3 | 1.6 | 92 | 100 |
| Enbrel® (1040542) | 2.6 | 1.7 | 89 | 107 |
| Enbrel® (1062728) | 2.5 | 1.8 | 85 | 98 |
| Enbrel® (1034018) | 2.8 | 1.8 | 81 | 96 |
| Enbrel® (1034842) | 2.5 | 1.8 | 85 | 95 |
| GP2015 process intermediate (CAP.E) | 3.4 | 1.6 | 76 | 98 |
| GP2015 late eluting HIC fraction | 5.5 | 2.0 | 58 | 93 |
| 1.6 | Mean | 99 | ||
| 14 | RSD | 4 |
The degree of potency and the relative amount of C78-C88, as determined by non reducing peptide map analysis, was assessed in selected GP2015 (Erelzi®) and Enbrel® reference product samples before and after exposure to serum-like redox conditions (see methods section for details). Following exposure, a concomitant elimination of incorrect disulfide bridging and restoration of potency was observed in all samples. Mean values of C78-C88 and potency following redox treatment are indicated along with the relative standard deviation (RSD).