TABLE 3.
Quality control analysis of accession lot physical properties
| Lot | Strain | Clumpinga |
Uniform biomassb |
Liquid culturec |
Purity resultd | Mean CFU/OD (×108)e |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Score | Result | Avg | SD | CoV (%) | Result | Day OD >0.2 | Result | Avg CFU | CoV (%) | CFU/OD | Result | |||
| 036 | SL521 | 15.60 | Pass | 1.23 | 0.01 | 1 | Pass | 1.00 | Pass | Pass | 4.78 | 7 | 3.90 | Pass |
| 039 | SL524 | 19.00 | Pass | 6.50 | 0.46 | 7 | Pass | 0.85 | Pass | Pass | 18.50 | 17 | 3.25 | Pass |
| 040 | SL525 | 14.00 | Pass | 5.70 | 0.10 | 2 | Pass | 1.10 | Pass | Pass | 9.67 | 48 | 1.49 | Pass |
| 062 | SL547 | 14.00 | Pass | 5.93 | 0.15 | 3 | Pass | 0.85 | Pass | Pass | 18.70 | 24 | 3.15 | Pass |
Particle sizes of rBCGD ΔleuCD clumps visualized by microscopy were assigned a clumping score. A passing score was <40.
Consistency of optical density between three vials was assessed by OD600 covariance (CoV). The target OD600 for lot 036 was 1 and the target for lots 039, 040, and 062 was 5. A passing covariance was <15%.
Recovery of thawed accession lot material in liquid culture was examined by daily monitoring of the optical density. A passing lot achieved OD600 of >0.2 in <7 days of growth.
The accession lot material was streaked on chocolate agar, and plates were observed for contaminating organisms. A passing lot yielded no contaminating colonies after 28 days of incubation.
The accession lot material was diluted and plated to measure the ratio between the number of CFU and optical density. A passing lot possessed a CFU/OD ratio of >0.1.