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生物制药 4.0

融合先进的封闭式加工技术、PAT、数据分析、自动化和控制软件，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

对新疗法不断增长的需求、降低成本的持续压力以及新型模式的成功，正在推动生物制药行业的变革。

无论是生物技术数字化、生物加工 4.0 还是未来的生物制造设施，都有许多目标需要平衡。为了保持竞争力，新兴和成熟的生物技术公司以及 C(D)MO 都需要在不影响质量或合规性的前提下提高速度、效率、灵活性和可扩展性。在这些要求的基础上，还必须提供更大的价值，并与企业的可持续发展目标保持一致，而这一切都必须在高度规范的环境中实现。

数字化生物制造：

您的数字化转型可加快全球患者获得生物制药的速度。为了帮助您取得成功，并帮助您在不同模式和生产规模下实现雄心勃勃的生物制造目标，我们提供了先进的端到端融合产品组合为上游和下游的技术。与过程分析技术（PAT）相结合，我们的 数据分析、自动化和控制软件推进装置、工厂和企业级数字化成熟度。

无论您是开发强化或连续生物工艺，还是开发未来的自主设施，BioContinuum™ 平台都能为您提供构建模块和专业知识，帮助您将性能和生产率提升到新的水平。

BioContinuum™平台：未来生物制造设施的推动者！

促进上游强化的先进生物制造技术

强化和连续上游加工（USP）

  • 种群强化
  • 生产和收获强化
  • 种群强化连续上游 (USP) 加工
    • 种子列车强化
    • 生产和；收获强化
用于下游强化的先进生物制造技术

Intensified &连续下游 (DSP) 处理

  • 强化捕获
  • 病毒灭活
过程分析技术（PAT）

工艺分析技术 (PAT)过程分析技术 (PAT)

  • 拉曼光谱
  • 自动无菌采样
两名科学家在实验室查看计算机显示器上的生物处理可视化数据

生物处理数据分析软件

  • Bio4C ProcessPad™ 软件
身着白大褂的女科学家使用笔记本电脑，使用控制软件自动监测和控制生物处理装置的运行

生物处理自动化和控制软件

  • 生物 4C ACE™ 软件
两名科学家站在实验室里，一名男性穿着兔子服，一名女性穿着便装

用于生物制造的封闭处理

  • 无菌取样
  • 切向流过滤支架和系统
  • 最终无菌过滤和灌装

相关视频

Slide 1 of 3
未来先进的数字化生物工艺
未来先进的数字化生物工艺
Scenarios of digitalized, intensified, and continuous biomanufacturing processes
未来生物处理的愿景
未来生物处理的愿景
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

利用生成式人工智能改变制药运营：从数据孤岛到智能洞察

Transforming Pharma Operations with Generative AI: From Data Silos to Intelligent Insights

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 和 APQR 工作流程，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过程中的 PAT 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.

利用拉曼光谱监测灌注中的 CCP 和 CQA

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：加速获取工艺和质量数据

自动化无菌采样：上游：加速获取工艺和质量数据


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.

有效实施多柱色谱 (MCC)

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.

在灌流细胞培养过程中实现糖基化监测

。

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 4

文章：您认为未来最具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：生物制造数字化：最新进展

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：让生物制剂驶上快车道

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Mycenax生物技术公司签署非约束性谅解备忘录，推动生物处理技术的创新


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

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