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Table 2 Cell culture platform evolution from conventional to intensified fed-batch production

From: Development of an intensified fed-batch production platform with doubled titers using N-1 perfusion seed for cell culture manufacturing

Category

Parameter

Process A

Process B

Process C

Media

Seed expansion

B1 + MSX

B1 + MSX

B1 + MSX

Production basal

B1

B1 or B1 enriched

B2 or B2 enriched

Feed

F1

1.3 × F1 or 1.3 × F1 enriched

F2 or F2 enriched

Process mode

N-2 seed

Batch

Batch

Perfusion or batch

N-1 seed

Batch

Enriched batch or fed-batch

Perfusion

Production (N)

Conventional fed-batch

Intensified fed-batch with non-perfusion N-1

Intensified fed-batch with perfusion N-1

Production process parameters

Inoculation density (× 106 cells/mL)

0.3–1.5

3.0–6.0

10–20

Feeding strategy

Fixed at 3.6% of initial volume from Day 3

Variable

Variable

Temperature shift

No

Variable

Variable

Harvest

Day

Day 14

Day 10–14

Day 10–14

Process yield

Final normalized titer

0.1–0.3

~ 0.5

~ 1.0

  1. The Process C final titer was normalized as 1 for each of mAb1, mAb3 and mAb4, while the Process C titer on Day 10 was normalized as 1 for mAb2