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生物制药4.0

融合先进、封闭式加工就绪技术、过程分析技术、数据分析、自动化及控制软件，打造未来工厂

主页完整的产品系列生物制药4.0

生物制药4.0：数字化转型

对新型疗法日益增长的需求、持续的成本削减压力以及创新治疗模式的成功，正推动着生物制药行业的变革。

无论称之为生物技术数字化、生物加工4.0还是未来生物制造工厂，都需平衡多重目标。 为保持竞争力，新兴与成熟生物技术企业及合同研发制造组织（C(D)MO）必须在不牺牲质量与合规的前提下，提升速度、效率、敏捷性及可扩展性。在此基础上，还需创造更高价值并契合企业可持续发展目标——所有这些都需在高度监管的环境中实现。

数字化生物制造：迈向未来封闭式生产设施的进化之路

您的数字化转型将加速全球患者获得生物制药的进程。为助力您在不同制备模式和生产规模下实现雄心勃勃的生物制造目标，我们提供涵盖上游与下游工艺的先进封闭式处理就绪技术，构建融合型端到端解决方案。结合过程分析技术（PAT），我们的数据分析、自动化及控制软件将推动单元、工厂乃至企业层面的数字化成熟度提升。

无论您选择何种发展路径——开发强化或连续生物工艺，抑或打造未来的自主化生产设施——BioContinuum™平台都将提供构建模块与专业知识，助您实现性能与生产力的全新突破。

BioContinuum™平台：助您打造未来生物制造设施的利器！

用于上游强化生产的高级生物制造技术

强化与持续上游（USP）处理

  • 种子列车强化
  • 生产与收获强化
用于下游强化生产的先进生物制造技术

强化与持续的下游处理（DSP）

  • 强化捕获
  • 病毒灭活
过程分析技术（PAT）

过程分析技术（PAT）

  • 拉曼光谱学
  • 自动化无菌采样
两名科学家在实验室里，正通过电脑显示器审阅生物加工数据的可视化呈现。

生物工艺数据分析软件

  • Bio4C ProcessPad™ 软件
身着实验白大褂的女科学家正使用笔记本电脑，通过控制软件对生物工艺单元操作进行自动化处理、监测与控制。
两名科学家站在实验室里，一名男性穿着兔子装，一名女性穿着便装。

生物制造的封闭式处理

  • 生物加工连接/断开
  • 无菌采样
  • 切向流过滤器及系统
  • 最终无菌过滤与灌装

相关视频

Slide 1 of 3
未来先进数字化生物工艺
未来先进数字化生物工艺
Scenarios of digitalized, intensified, and continuous biomanufacturing processes
未来生物加工愿景
未来生物加工愿景
Digital transformation in biotech: innovative technologies for next generation bioprocessing
生物制药领域大数据主题专家访谈
生物制药领域大数据主题专家访谈
BioContinuum™ Platform addressing digital transformation challenges

相关网络研讨会

Slide 1 of 7
Scientist in a lab environment wearing a lab coat and protective gloves sitting at desk

生成式人工智能重塑制药运营：从数据孤岛到智能洞察

GenAI simplifies data analysis, speeds investigations, enables real-time CPV with predictive monitoring, and streamlines APQRs by unifying data across systems.

Bioprocess engineer at her computer using ProcessPad for CPV and APQR

整合CPV与APQR工作流程以减少冗余

CPV data and reporting are used in APQR but the programs are usually not aligned causing duplicate work. Integrating CPV and APQR with unified data, automated data gathering, and analytics improves operational efficiency.

Graphic demonstrating how direct access to on-line high-performance liquid chromatography (HPLC) data can empower advanced process control.

在线高效液相色谱作为生物加工中的过程分析技术工具

Joint webinar with Agilent Technologies: Use case demonstrating the utility of on-line HPLC to monitor and control antibody aggregation levels in bioprocessing. 

Chart showing in-line and real-time measurement of CPPs and CQAs such as TCD, VCD and the concentration of glucose, lactate and ammonium.

拉曼光谱在灌注中关键控制点与关键质量属性监测中的应用

Case studies on the implementation of Raman spectroscopy for monitoring in bench-scale CHO cell intensified seed trains (N-1), steady state and dynamic perfusion (N) cultures. Understand the value of combining automated sampling with Raman spectroscopy for increased sample frequency, leading to more accurate measurement of CPPs and CQAs in upstream bioprocesses.

Scientist in a lab in front of a computer using bio4c processpad.

上游自动化无菌采样：加速获取工艺与质量数据


Automated sampling system and its utilization in perfusion cell culture for upstream process development reducing the time to measure CQAs and manual labor, accelerating access to analytical data, and decreasing risk.

Steps to 3-column capture continuous chromatography principle.

多柱色谱法（MCC）的有效实施

A bioprocessing technique where multiple columns are loaded in series and then cycled for elution, regeneration, and equilibration allowing fuller utilization of the potential resin binding capacity, and rapid cycling of much smaller columns suitable for continuous bioprocessing.

A laboratory setting featuring advanced scientific equipment, including multiple chromatography systems and a computer monitor displaying data. A researcher in a lab coat is actively engaged in an experiment at a workbench, surrounded by various instruments and supplies essential for laboratory analysis.

在灌注细胞培养过程中启用糖基化监测

This webinar explores how automation strategies and control schemes facilitate rapid analytical results, crucial for managing glycosylation variability that affects product quality.

相关资源

Slide 1 of 5

白皮书：劳动力4.0：生物制药行业的长期成功之道


A public-private approach to workforce 4.0 development, transitioning from conventional factories to “smart” manufacturing facilities.

文章：您认为当前最具有颠覆性或变革性的技术或发展是什么？


The use of induced pluripotent stem (iPS) cell–derived therapies has such potential to expand the types of indications that may be treated via cellular therapy.

文章：生物制造的数字化：现状更新

Industry 4.0, conceptualized by the digitalization-led convergence of digital, physical, and virtual assets, brings a paradigm shift in the totality of operations across the value chain.

播客：加速生物制剂发展进程

Medicines derived from biological compounds are the fastest-growing class of drugs. We discuss how to accelerate the production of these biologics to a rapid pace.

新闻稿：与迈赛纳斯生物技术公司签署非约束性谅解备忘录，推动生物加工技术创新


{hcomapny} announces a non-binding MoU with Mycenax Biotech to optimize bioprocessing production of life-changing biological therapies.

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