A Mab A Case Study In — Bioprocess Development

Complete the pipeline from transfection to a frozen robust process within 14 months. 2. Upstream Process Development: Maximizing Productivity

The team adjusts the buffer to 10 mM histidine (pH 6.0) with 150 mM arginine and 5% trehalose. This combination reduces viscosity to 8 cP at 120 mg/mL, allowing efficient TFF.

[Quality Target Product Profile (QTPP)] │ ▼ [Critical Quality Attributes (CQAs)] │ ▼ [Risk Assessment / FMEA] │ ▼ [Critical Process Parameters (CPPs)] │ ▼ [Design Space] │ ▼ [Control Strategy] From Target Profile to Control Strategy A Mab A Case Study In Bioprocess Development

The bioprocess pipeline for mAb A begins with the . The QTPP outlines the clinical performance goals, dosage requirements, and safety standards for the drug.

Process development moved from shake flasks to bench-top bioreactors, then to pilot-scale (e.g., 50 L to 500 L). Complete the pipeline from transfection to a frozen

Bioprocess development isn’t just about "picking the best cell." We optimized the fed-batch culture media . By shifting from a standard glucose feed to a dynamic feeding strategy based on metabolic markers (like lactate and ammonia levels), we reduced metabolic stress on the cells. The result? The cells produced slightly less total protein, but the quality profile was pristine , with aggregation dropping below 1%.

Defines the clinical goals, including safety, efficacy, and dosage. Critical Quality Attributes (CQAs): This combination reduces viscosity to 8 cP at

: It proposes a robust control strategy that includes real-time release testing (RTRT) and risk-based process monitoring. Strengths

The journey began with the selection of a Chinese Hamster Ovary (CHO) cell line expression system, specifically CHO-DG44.

A tangential flow filtration (TFF) system with a 30 kDa regenerated cellulose membrane concentrated the mAb to its final target formulation of 100 mg/mL. It simultaneously exchanged the buffer into a histidine-sucrose formulation stabilizing the drug substance for long-term storage. 4. Analytical Characterization and Quality Control