According to the FDA website, the only licensed Lonza facility for vaccines, blood and biologics is Lonza Walkersville, and that is for LAL not cells.
The data you quote are for the adjacent mammalian cell culture facility (for manufacture of monoclonal antibodies), which is licensed by CDER for analysis, API manufacture, label, manufacture and pack.
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-172
-
- There are more pages in this discussion • 104 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
96.0¢ |
Change
-0.010(1.03%) |
Mkt cap ! $1.096B | |||
| Open | High | Low | Value | Volume |
| 98.0¢ | 98.5¢ | 95.0¢ | $2.617M | 2.715M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 5 | 107932 | 95.5¢ |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| 96.0¢ | 34142 | 1 |
View Market Depth
| Last trade - 16.10pm 13/08/2024 (20 minute delay) ? |
| MSB (ASX) Chart |