Table 2.
Transfer # | Product | Prior facility experience? | New process? | Risk score | Intensity of TT support effort | # of batches needed to meet expectations |
---|---|---|---|---|---|---|
1 | 1 | No | Yes | 2 | Full Court Press | 2 |
2 | 3 | No | Yes | 3 | Lean | ~ 3 |
3 | 1 | Yes | Yes | 1 | Lean | Never (tried 2) |
4 | 1 | Yes | Yes | 1 | Moderate | 1 |
5 | 3 | Yes | No | 0 | Moderate | 2 |
6 | 1 | Yes | No | 0 | Lean | 1 |
7 | 4 | Yes | Yes | 2 | Heavy | 4 |
8 | 1 | Yes | No | 0 | Lean | 1 |
9 | 1 | Yes | Yes | 1 | Moderate | 8a |
10 | 5 | No | No | 2 | Moderate | 2 |
11 | 6 | Yes | No | 1 | Lean | 1 |
12 | 3 | Yes | No | 0 | Lean | 1 |
13 | 1 | Yes | No | 0 | Lean | 5 |
14 | 5 | Yes | Yes | 1 | Lean | 1 |
15 | 6 | Yes | Yes | 1 | Lean | 1 |
16 | 3 | Yes | Yes | 1 | Lean | 1 |
17 | 7 | Yes | Yes | 2 | Heavy | 2 |
18 | 7 | Yes | Yes | 1 | Heavy | 2 |
19 | 8 | Yes | No | 1 | Lean | 1 |
20 | 9 | No | Yes | 3 | Lean | 1 |
21 | 7 | Yes | Yes | 1 | Heavy | 1 |
a90% of target performance was routinely achieved after three runs. Product #2 was scaled up prior to 2012. At some contract manufacturers, the participation by Amyris staff was limited due to CMO rules (i.e. for Product 9). Additionally, fermentation runs that failed due to equipment failure or contamination are not counted in tallying the number of batches needed to meet expectations