바이오공정 데이터 분석 소프트웨어

관련 자료

• 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.