Formulation screening is critical in optimizing protein colloidal, conformational and chemical stability to ensure the safety and efficacy of biotherapeutic medicines. Tangential flow filtration (TFF) is commonly utilized in development and manufacturing to exchange buffer and excipient components in order to arrive at the final formulation. The TFF process can be labor-intensive and time-consuming when manually regulating pump/membrane/scale/sensor systems. In addition, TFF systems with high surface area membranes have large hold-up volumes that require significant drug substance, which is a constraint when screening large design spaces and particularly during early development stages where material is limited. As a result, dialysis and centrifugal filtration techniques are often utilized for small volume (1 to 25 mL) formulation screening. These methods can require several days and significant analyst time and are non-representative of commercial processes and stresses. The Sartorius ambr® Crossflow, an automated TFF system, has been evaluated to address these limitations. The system is a low volume, automated buffer exchange system. The system features parallel processing of 1 to 16 channels, low volume requirements of 5 to 100 mL, flexible sequence setup and online conductivity and pH monitoring. The data presented will describe the capabilities and process and product quality comparability evaluation relative to the traditional, larger scale (50–5000 mL) TFF system.

Increasing the efficiency of drug product development by automation of the tangential flow filtration system for early formulation screening

2019 Spring National Meeting

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