End-to-end continuous bioprocessing: Impact on facility design, cost of goods, and cost of development for monoclonal antibodies

Area of Science:

• Biopharmaceutical Manufacturing
• Process Engineering
• Economic Analysis

Background:

• Traditional batch manufacturing for monoclonal antibodies (mAbs) faces challenges in cost-efficiency and scalability.
• Continuous processing technologies offer potential advantages but require thorough economic evaluation.

Purpose of the Study:

• To systematically evaluate the business case for continuous processing versus batch manufacturing of mAbs.
• To quantify the trade-offs between manufacturing and development costs for different processing strategies.

Main Methods:

• Development of a decision tool integrating cost of goods (COG), development costs, and equipment sizing for batch, hybrid, and continuous processes.
• Analysis of cost of goods (COG) for single-use and stainless steel facilities across various scales (kg to tons).
• Evaluation of project lifecycle costs, considering both development and commercial manufacturing expenses.

Main Results:

• Single-use continuous facilities show substantial COG savings (~35%) over stainless steel batch facilities at 100-500 kg annual demand.
• At larger scales (1-3 tons), savings for continuous facilities decrease (~10%) due to the need for parallel trains.
• Single-use batch facilities are cost-competitive with continuous options only at very low scales (100 kg/year).
• End-to-end continuous facilities, despite higher development costs, are more cost-effective over the project lifecycle.

Conclusions:

• Continuous processing, particularly with single-use technologies, presents a strong economic case for mAb production at moderate annual demands.
• The choice between batch and continuous processing depends on scale, facility type, and lifecycle cost considerations.
• Continuous manufacturing can be more economically viable than traditional batch methods when considering total project costs from development through commercialization.