Implementation of a New Membrane and the Re-use in a Tangential Flow Filtration System

Abstract

Tangential Flow Filtration (TFF) is commonly used as the last steps in protein purification processes at Biopharmaceutical Plants for clarification and concentration of the target protein. Since the membranes are expensive, the industries should maximize its use in order to minimize associated costs. A common membrane is made Polyethersulfone. As specified from the manufacturer, it can be cleaned using Sodium Hypochlorite (NaOCl). Since TFF is the last step in the manufacturing process, a Biopharmaceutical Plant have the concern of using this cleaning agent since this solution can alter adversely the safety, identify, strength, purity and quality of the product. For this reason, it was chosen not to validate a cleaning strategy for Polyethersulfone TFF cassettes in a specific industry. Instead, new membranes are installed for the manufacturing process per production lot. A typical cost of membrane ranges between $5,000 and $7,000. For a process that requires eight membranes, the cost for a biotechnology plant is approximately $40,000 per lot. This proposed project consists in changing Polyethersulfone membranes to Regenerated cellulose, which can be easily cleaned with sodium hydroxide, commonly used in pharmaceutical industry. By demonstrating the effectiveness of membrane reuse via cleaning validation, a typical biotechnology industry can save more than $2 million in an annual basis. Key Terms - Biopharmaceutical, Cleaning, Membranes, Tangential Flow Filtration.