(337as) Continuous Crystallization of Monoclonal Antibodies

Research Interests: Precipitation/crystallization of monoclonal antibody, Biological testing, Analytical testing, Process Development

Monoclonal antibodies (mAbs) have gained considerable recognition as effective and targeted therapeutic agents in recent years. However, challenges in downstream processing, particularly in terms of purification capacity and cost-effectiveness, remain. This study aims to address these challenges by investigating the potential of continuous crystallization as alternative methods to chromatography for mAb purification. The main objective is to enhance purification efficiency and reduce associated costs.

While precipitation and crystallization techniques have shown promise in purifying mAbs, further research is needed to develop technologies that can effectively purify a wide range of mAbs. The study focuses on improving purification capacity, reducing costs, and optimizing yield, purity, and the preservation of biological activity through the implementation of batch, semibatch, or continuous experiments.

To achieve these goals, the study explores the use of continuous precipitation and crystallization methods. Precipitation and the utilization of tangential flow filtration, is being investigated as a pretreatment process to enable crystallization of mAbs from the clarified bioreactor sample. Continuous operation is particularly advantageous due to the slow kinetics typically observed in mAb crystallizations, leading to higher productivity compared to batch methods. To ensure precise process control and monitoring, in-line data acquisition is employed, capturing key parameters such as pH, conductivity, and protein concentration. These parameters play a crucial role in optimizing the precipitation and crystallization processes, ensuring consistent and reliable outcomes.

In summary, this study aims to advance mAb purification by exploring continuous precipitation and crystallization techniques as viable alternatives to chromatography. By integrating in-line process control data and optimizing experimental conditions, the objective is to increase purification capacity, reduce costs, and enhance yield, purity, and the preservation of biological activity. The research holds significant potential in developing efficient and cost-effective downstream processing strategies for mAbs.