生物工艺数据分析软件

Data Visualization and Analytics Software for Biotech

生物制药企业会从进料信息、质量控制结果、LIMS、QMS、MES系统和单元操作传感器生成和收集海量的数据。不过，由于数据孤岛、数据格式不一、数据治理问题等影响因素，70%的生物工艺数据被弃之不用。

鉴于加强工艺认知和提高产品质量都需要更多数据，业内开始采用数据可视化和分析工具，同时结合数据湖、云计算、增强现实或虚拟现实（AR和VR）和预测分析等技术来处理数据。

数据管理、可视化和分析软件

为了避免费时费力的人工操作，生物科技公司需要智能化的数据管理工具来自动采集手动记录、电子表格、外部数据库和设备数据等异质来源的数据，并整合为一种分析就绪格式。汇总后的单一数据集可用于数据分析、可视化和工艺监测技术，从而提高产品质量和优化工艺过程。

Bio4C ProcessPad™软件

Bio4C ProcessPad^™软件是数据可视化、分析和工艺监测平台，可帮助您轻松采集、聚合与分析生物工艺数据。

相关资源

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.

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