生物工艺数据分析软件

Data Visualization and Analytics Software for Biotech

生物制药企业会生成并收集海量数据——涵盖原料信息、质量控制结果、实验室信息管理系统（LIMS）、质量管理体系（QMS）、制造执行系统（MES）以及单元操作传感器的数据。然而，由于数据孤岛、格式不统一、数据治理问题等因素，70%的生物加工数据未能得到有效利用。

为深化工艺认知、提升产品质量，行业正积极采用数据可视化与分析工具，并结合数据湖、云计算、增强现实/虚拟现实（AR/VR）及预测分析等技术手段。

提出一个数据分析问题

数据管理、可视化与分析软件

为避免耗时的手动操作，生物技术公司需要智能数据管理工具，能够自动从手动记录、电子表格、外部数据库和机器数据等分散来源收集数据，并将其整合为可直接分析的格式。生物制造商现可对这一统一数据集应用数据分析、可视化及过程监控技术，从而提升产品质量并优化生产流程。

Bio4C ProcessPad^™ 软件

Bio4CProcess Pad^™软件是一款数据可视化、分析与工艺监控平台，可让您轻松获取、整合并分析生物加工数据。

相关资源

White Paper: Workforce 4.0: The Long-Term Success of the Biopharmaceutical Industry
A public-private approach to workforce 4.0 development, transitioning from conventional factories to “smart” manufacturing facilities.
Data Sheet: Bio4C ProcessPad™ Software
Bio4C ProcessPad™ software is a data collection, visualization, and analytics platform that enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).
Article: Continued Process Verification
Continued process verification is critical to maintain the strength, quality, and purity of the final drug product. It is a regulatory expectation as manufacturers are instructed to ensure their process remains in a continual state of control. Learn more in this technical article.
Article: Bioprocess Monitoring and Control with Multivariate Data Analysis
Manual monitoring of CPPs and CQAs is time-consuming, labor-intensive, and may delay informed decisions on process performance. Multivariate data analysis (MVDA) makes possible a proactive, near real-time approach to monitoring, controlling, and predicting quality and productivity in biomanufacturing processes.
Article: Software Simplifies Compliance with 21 CFR Part 11 and EudraLex Volume 4 Annex 11
Regulatory agencies wish to ensure electronic records and signatures are equivalent to paper-based records and handwritten signatures. Beyond proving equivalency, software used for electronic records and signatures offers benefits like access control, audit trials, data integrity, and easy search and retrieval of information.
White Paper: Next-Generation Monitoring of Bioprocessing to Enable Smart Data Management and Analysis
The bioprocess lifecycle for any therapeutic protein includes a complex series of upstream and downstream activities starting with drug development followed by manufacturing, quality release and finally shipping the drug to the market.
Brochure: Process Development and Drug Manufacturing: Support Services
We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.