A-Mab Case Study a landmark industry document that demonstrates how Quality by Design (QbD)

3.5 Viral Filtration

Bioprocess Development

But having a brilliant molecule is only half the battle. The journey from a discovery in a research lab to a viable drug on the shelf is paved with complex engineering challenges. This is the realm of .

Conclusion

Solution:

Automated pH control using 1M sodium bicarbonate (not NaOH, which would cause localized pH spikes). Additionally, the team adds 50 mM arginine to the harvest hold tank, which acts as a chaotropic agent to stabilize the antibody.

Target Product Profile (TPP)

Product development begins with the , which outlines the desired clinical safety and efficacy. From this, scientists identify Critical Quality Attributes (CQAs) —physical, chemical, or biological properties that must be within an appropriate limit to ensure product quality.

multivariate process model

A linked:

  • Increasing copper sulfate (a cofactor for disulfide bond formation) from 0.5 µM to 5 µM → boosted titer by 40%
  • Adding a chemically defined lipid supplement → reduced cell debris
  • Lowering temperature to 32°C post-exponential phase → extended viability

4.4 Potency (ADCC reporter bioassay)