Optimization of Clarification Step in Pneumococcal Polysaccharide Conjugate Vaccine Manufacturing: Evaluating the Performance of Depth Filters

Peer-Reviewed

Article submitted: September 13, 2023.
Article accepted: January 4, 2024.

Abstract

Pneumococcal infections, stemming from Streptococcus pneumoniae, present a substantial health risk, especially among vulnerable populations. To counter this, vaccines employing bacterial capsular polysaccharide (CPS) have been developed. However, the purification of CPS is a pivotal vaccine manufacturing step, with the clarification process playing a crucial role in achieving optimal product yield and purity. This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes. Evaluation criteria include hydraulic performance, throughput, and filtrate turbidity. Employing the constant flow rate sizing method for scale-up, the study determines that synthetic depth filters with suitable pore sizes demonstrate low resistance and high throughput, suggesting their efficiency in impurity removal. Overall, optimizing the clarification step is crucial for improving downstream processing of pneumococcal polysaccharide conjugate vaccines, and this study provides valuable insights into selecting and optimizing depth filters for efficient clarification, ensuring high product quality and process efficiency in vaccine manufacturing.

About the authors

Swapan Kumar Jana* is director, R & D and Production, PPCV at Serum Institute of India Pvt Ltd, skjana@seruminstitute.com.
Amol Dattatraya Mahajan is manager, R & D and Production, PPCV at Serum Institute of India Pvt Ltd.
Vishal Vijayan is MSAT specialist; Praveen Kumar Ravichandran is MSAT specialist; Subhasis Banerjee is technical consultant; and Sourabh Kumar is manager, MSAT, all at Merck Life Science Pvt Ltd, India.

*To whom all correspondence should be addressed.

Article details

BioPharm International®
Vol. 37, No. 5
May 2024
Pages: 17-23

Citation

When referring to this article, please cite it as Jana, S.K. et al. Optimization of Clarification Step in Pneumococcal Polysaccharide Conjugate Vaccine Manufacturing: Evaluating the Performance of Depth Filters. BioPharm International 2024 37 (5).