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Biopharmaceutical production is moving toward intelligent and lean manufacturing. The integration of PAT and Digital Twin enables real-time monitoring and optimization of bioreactor processes. This paper reviews their applications, discusses the intelligent closed-loop control for robustness, yield and quality consistency, and analyzes implementation paths and challenges.

Continuous downstream purification is key to modern biomanufacturing, overcoming batch inefficiencies and enabling seamless integration with continuous upstream culture. This paper examines the technologies and strategies of continuous downstream processing (cDSP), analyzes its advantages in productivity, cost and flexibility, and discusses challenges in robustness, compliance and integration.

Perfusion culture, a core upstream bioreactor technology, boosts monoclonal antibody (mAb) productivity and quality. This paper reviews its recent advances, focusing on cell retention device innovations, optimized process control, and key considerations for large-scale commercialization, providing technical guidance for biopharmaceutical companies.

This document is a practical, in-depth guide detailing how bioreactors meet GMP requirements in regulated industries such as pharmaceuticals. It focuses on the equipment validation lifecycle model, covering user requirements specification (URS), design qualification (DQ), performance qualification (PQ), and ongoing maintenance. It also provides a detailed analysis of sterilization in place (SIP), including validation logic and documentation, offering actionable compliance advice.

This document focuses on the regulatory and standard environment of the bioreactor industry worldwide and domestically. It reviews global standardization led by the ISO, especially the standardization process of ISO/TC 276 WG4 in bioprocessing. It also analyzes mandatory requirements of GMP and other key regulations on bioreactor design, manufacturing and validation, providing a framework for global market access and compliance.

Guangdong’s 2026 biomanufacturing policy highlights bioreactors as key to industry bottlenecks. It backs R&D, ISO-aligned standards, and AI/IoT-driven ecosystems. Biomedicine, cell therapy, and bio-based materials boost demand. Enterprises should prioritize standardization, high-growth sectors, and GMP compliance, accelerating the industry’s tech upgrade and global access.