Process Design of CDMO Aseptic Formulation Workshop for PD-1 Antibody and Protein Products

Jinjie Zhu; Songzhi Li; Siwen Wang; Chengyu Chen; Xiaochao Zhen

doi:10.62051/gewhn079

Authors

Jinjie Zhu
Songzhi Li
Siwen Wang
Chengyu Chen
Xiaochao Zhen

DOI:

https://doi.org/10.62051/gewhn079

Keywords:

biopharmaceuticals; CDMO mode; GMP requirements; Sterile preparation workshop; Liquid preparation process.

Abstract

With the rapid development of biotechnology and the improvement of global health awareness, the biopharmaceutical industry has developed rapidly. The CDMO model has become an important means for many biopharmaceutical enterprises to optimize resource allocation and improve research and development efficiency. The aim of this study is to provide a scientific and cost-effective sterile formulation workshop design scheme that meets GMP requirements. The study aims to avoid potential risks to materials during the CIP process by conducting an overall CIP/SIP process with the filling machine after material filling in the liquid mixing process. Based on the first law of thermodynamics, energy balance is calculated to determine the thermal load of the equipment or device, and further determine the type, quantity, and main process dimensions of the heat transfer equipment. This study aims to ensure product quality, improve production efficiency to cope with global market competition and the complexity of supply chains, as well as the development of personalized and precision medicine.

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