High-Throughput Process Development for Biopharmaceuticals.

Area of Science:

• Biopharmaceutical Manufacturing
• Process Development
• Drug Discovery Acceleration

Background:

• Process development is critical for biopharmaceutical candidates entering clinical trials.
• High-throughput process development (HTPD) significantly reduces development timelines.
• HTPD is crucial for late-stage development, commercial processes, and regulatory filings.

Purpose of the Study:

• To review the current state of HTPD methodologies.
• To examine HTPD applications in cell culture, downstream purification, and analytical techniques.
• To propose an integrated HTPD strategy for accelerated biopharmaceutical development.

Main Methods:

• Review of current HTPD methodologies.
• Analysis of HTPD applications across bioprocessing stages.
• Conceptualization of integrated HTPD workflows.

Main Results:

• HTPD significantly shortens biopharmaceutical process development timelines.
• Current HTPD covers cell culture, purification, and analytics.
• Integration of HTPD across disciplines offers substantial acceleration.

Conclusions:

• HTPD is a key enabler for rapid biopharmaceutical development.
• Integrated HTPD strategies can create a powerful process development engine.
• Accelerated development through HTPD facilitates faster drug candidate progression.