Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk

Merve B Adali,Gianluca Boccardo,Antonello A Barresi,Roberto Pisano

doi:10.3390/pr8060709

Abstract

Pharmaceutical manufacturing is evolving from traditional batch processes to continuous ones. The new global competition focused on throughput and quality of drug products is certainly the driving force behind this transition which, thus, represents the new challenge of pharmaceutical manufacturing and hence of lyophilization as a downstream operation. In this direction, the present review deals with the most recent technologies, based on spray freeze-drying, that can achieve this objective. It provides a comprehensive overview of the physics behind this process and of the most recent equipment design.

Highlights

The current worldwide problems with the coronavirus pandemic have demonstrated the fragility of the pharmaceutical supply chain
The spray freeze-drying (SFD) process has attracted a keen interest as a potential continuous technology for pharmaceutical manufacturing
Most of the SFD technologies have been designed to operate in batch mode and their application in a real industrial environment is critical due to the strict requirements of sterility and accurate dosage of pharmaceutical manufacturing

Summary

Introduction

The current worldwide problems with the coronavirus pandemic have demonstrated the fragility of the pharmaceutical supply chain. The implementation of continuous manufacturing of biopharmaceuticals would offer tremendous benefits, providing a more agile and reliable supply chain for both existing and new products, that can rapidly address emergencies. Despite having witnessed the development of continuous technologies for the manufacturing of specific products, many barriers remain to the formation of an overall strategy [1,2]. The transition from the consolidated batch technology to a completely new strategy is hindered by the lack of personnel expertise and training. There is a great opportunity in the adoption of continuous platforms for the new generation of drug products, i.e., biopharmaceuticals [3]. The relatively short shelf-life stability of liquid biomolecular-based drugs, as well as cold chain storage and transport costs, makes it necessary to remove water by drying

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Conclusion