Analysis of the Shear Stresses in a Filling Line of Parenteral Products: The Role of Tubing

Author:

Moino Camilla1ORCID,Scutellà Bernadette2,Bellini Marco2,Bourlès Erwan2,Boccardo Gianluca1ORCID,Pisano Roberto1ORCID

Affiliation:

1. Department of Applied Science and Technology, Politecnico di Torino, 24 Corso Duca degli Abruzzi, 10129 Torino, Italy

2. GSK, 89 Rue de l’Institut, 1330 Rixensart, Belgium

Abstract

Parenteral products appear to be sensitive to process conditions in bioprocessing steps, such as interfacial stress and shear stress. The combination of these elements is widely believed and proven to influence product stability, but the defined roles of these players in the product damage process have not yet been identified. The present work addresses a current industrial problem, by focusing on the analysis of shear stress on protein-based therapeutics flowing in tubing by means of Computational Fluid Dynamics simulations. The purpose of this article is not to pinpoint the mechanism triggering the damage of the product, but it represents the first step towards wider experimental investigations and introduces a new strategy to quantify the average shear stress. The field of scale-down approaches, used to scale the commercial process down to the laboratory level, is also explored. Since quality control is critical in the pharmaceutical realm, it is essential that the scale-down approach preserves the same stress exposure as the commercial scale, which in the present work is considered to be that resulting from shear effects. Therefore, a new approach for scaling down the commercial process is proposed, which has been compared with traditional approaches and shown to provide greater representativeness between the two scales.

Funder

GlaxoSmithKline Biologicals SA

Publisher

MDPI AG

Subject

Process Chemistry and Technology,Chemical Engineering (miscellaneous),Bioengineering

Reference61 articles.

1. Kovarcik, D.P. (2016). Critical Factors for Fill–Finish Manufacturing of Biologics. Bioprocess Int., Available online: https://bioprocessintl.com/manufacturing/fill-finish/critical-factors-for-fill-finish-manufacturing-of-biologics/.

2. Protein formulation and fill-finish operations;Patro;Biotechnol. Annu. Rev.,2002

3. Current perspectives on stability of protein drug products during formulation, fill and finish operations;Rathore;Biotechnol. Prog.,2008

4. Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality;Das;J. Pharm. Sci.,2022

5. Buxbaum, E. (2007). Fundamentals of Protein Structure and Function, Springer.

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