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Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing
Hayato Ishimoto1, Manabu Kano2, Hirokazu Sugiyama3
1Formulation Research, Pharmaceutical Science & Technology Core Function Unit, Medicine Development Center, Eisai Co., Ltd.
Chemical & Pharmaceutical Bulletin
|December 10, 2020
Summary
This document outlines a control strategy for continuous manufacturing of oral solid dosage forms, adapting existing batch manufacturing methods. It highlights differences in process development for continuous versus batch manufacturing.
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Process Control
Background:
- Continuous manufacturing is an emerging paradigm in pharmaceutical production.
- Established batch manufacturing principles offer a foundation for continuous processes.
- Adapting existing methodologies is crucial for successful implementation.
Purpose of the Study:
- To present an approach for establishing a control strategy for continuous manufacturing of oral solid dosage forms.
- To identify similarities and differences between batch and continuous manufacturing processes.
- To provide a framework for developing control strategies in pharmaceutical manufacturing.
Main Methods:
- Leveraging existing drug development, technology transfer, process control, and quality control methods.
- Analyzing process development differences between continuous and batch manufacturing.
- Illustrating a thought process for control strategy establishment.
Main Results:
- Existing batch manufacturing methods are largely applicable to continuous manufacturing.
- Process development requires specific considerations for continuous manufacturing.
- A structured approach to control strategy is feasible.
Conclusions:
- A robust control strategy can be developed for continuous manufacturing by adapting current practices.
- Understanding process development nuances is key to successful continuous manufacturing implementation.
- This work provides a foundational approach for the pharmaceutical industry.
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