Continuous Downstream Processing in Biopharmaceutical Manufacturing: A Review

IF 2.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Journal of Pharmaceutical Innovation Pub Date : 2026-09-16 DOI:10.1007/s12247-026-10914-2

Srinivasulu Katakam, Erik Hefti

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引用次数: 0

Abstract

Purpose

Continuous manufacturing has emerged as a promising alternative to conventional batch processing, offering potential improvements in efficiency, product quality, and sustainability. This review evaluates the economic, quality, sustainability, and scalability implications of continuous downstream processing in biopharmaceutical manufacturing and identifies lessons applicable to life-science industries.

Methods

A literature review was conducted using PubMed, ScienceDirect, and SpringerLink databases to identify peer-reviewed articles, industrial case studies, and regulatory guidance documents published between 2010 and 2025.

Results

Continuous downstream processing reduces manufacturing costs and improves equipment efficiency. Process Analytical Technology (PAT) enables real-time quality control, reducing variability and improving product purity and yields. Continuous systems lower material, water, and energy consumption while improving scalability and operational flexibility across life-science industries.

Conclusions

Continuous downstream processing is a technically viable and cost-effective technology for biopharmaceutical production. Implementation challenges, including validation complexity and workforce readiness, can be mitigated with emerging technologies such as digital twins and AI-enhanced PAT systems. Cross-industry evidence supports modular adoption strategies to accelerate implementation.

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生物制药生产中的连续下游加工：综述

连续生产已经成为传统批量加工的一种有前途的替代方法，在效率、产品质量和可持续性方面提供了潜在的改进。本文评估了生物制药生产中连续下游加工的经济、质量、可持续性和可扩展性，并确定了适用于生命科学行业的经验教训。方法利用PubMed、ScienceDirect和SpringerLink数据库对2010年至2025年间发表的同行评议文章、行业案例研究和监管指导文件进行文献综述。结果连续下游加工降低了制造成本，提高了设备效率。过程分析技术（PAT）实现实时质量控制，减少可变性，提高产品纯度和产量。连续系统降低了材料、水和能源消耗，同时提高了生命科学行业的可扩展性和操作灵活性。结论连续下游加工技术在生物制药生产中具有技术可行性和成本效益。实施方面的挑战，包括验证复杂性和劳动力准备情况，可以通过数字孪生和人工智能增强的PAT系统等新兴技术来缓解。跨行业证据支持模块化采用策略以加速实施。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-

CiteScore

3.70

自引率

3.80%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.