Table 1. Demonstration of NGS for virus detection.
Figure 1. Gen1 and Gen2 overall workflow with
SSI technology. SSI pools are employed for toxicology and early GMP
production runs. The final clone MCB is used for the rest of GMP
production.
Figure 2. Toxicology production from several COVID-19
molecules. (A): The titer data of some representative toxicology
production of COVID-19 mAb molecules. (B-F): Viability, VCD, glucose
level, lactate level and osmolality of Molecule D.
Figure 3. Comparable product quality among different batches of
pool production. One representative COVID-19 pool to support toxicology
run and two consecutive GMP runs with similar titer (A) and product
quality (B-D) as its 3L bioreactor evaluation.
Figure 4. Clone selection from SSI pools. The titer
(A), critical glycan species (B) and charge variants (C) data of
toxicology, GMP and top clone candidates are charted. Key product
quality attributes of Gen1 and Gen2 are comparable (D).
Figure 5. Preliminary cell line stability study.Expression levels (blue and orange bars) and titer variation (grey line)
between RCB and PDL30 cells.
Figure 6. Representative product quality comparison. (A) SEC
(B) charge variants (C) glycan comparison of one molecule among
transient expression, toxicology, Gen1 GMP production, top clone
candidates in AMBR, the final clone in 50L pilot, 500L pilot and 2000L
GMP production. (D) Titer (E) SEC (F) charge variants (C) glycan
comparison of one another molecule among toxicology, Gen1 GMP
production, Gen2 clonal bioreactor runs at different scales (3L, 15L and
500L GMP).
Figure 7. Representative timeline comparison. (A) A classical
accelerated 12-month CMC timeline illustration. (B) The envisaged
6-month CMC timeline illustration.