A Mab A Case Study In Bioprocess Development -

A Monoclonal Antibody (mAb): A Case Study in Bioprocess Development

Abstract

This paper examines the end-to-end bioprocess development lifecycle for a therapeutic monoclonal antibody (mAb), from molecule selection through commercial manufacturing and regulatory considerations. It integrates upstream cell line development, bioreactor process design, downstream purification, analytical characterization, formulation, scale-up, process validation, quality-by-design (QbD), risk assessment, and techno-economic analysis. Emphasis is placed on decision points that balance product quality, manufacturability, cost, and regulatory compliance, illustrated with data-driven examples and recommended best practices.

2. Upstream Process Development

Host & Vector: CHO-K1 cells transfected with a glutamine synthetase (GS) expression system. A Mab A Case Study In Bioprocess Development

Strategies to reduce cost of goods (COGs): titer improvement, continuous processing, high-capacity resins, single-use systems.

3. Downstream Processing (DSP) Development

3.1 Harvest & Clarification

• Primary recovery: Centrifugation (disk-stack, 10,000 ×g) + depth filtration (Pall Supracap 60).
• Yield: 92%, turbidity < 10 NTU.