Search results for "modeling" in Articles / App Notes

Article Optimizing Late-Stage and Commercial Cell-Culture Processes
Modeling and leveraging platform knowledge; extensive platform knowledge is enabling more efficient process validation as one study can support multiple products. A platform culture process also ena…

Article CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain Certificates of analysis can be used to monitor the reliability of products and their suppliers. By Susan J. Schniepp, distinguished fellow at…

Article Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…

Article Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins This study outlines methods for an alternative protein-polishing process for challenging proteins. …

Article Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…

Article Reconciling Sensor Communication Gaps
With those changes, process modeling to ensure product quality and smooth operation becomes crucial. Quality by design and its enablers—process analytics and advanced control strategies—move to the fr…

Article Biopharma Advances Demand Specialized Expertise
Jun 15, 2015 By BioPharm International Editors BioPharm International eBooks Volume 28, Issue 13 Contract service providers share insights on biopharma market developments and the impl…

Article Continuous Manufacturing: A Changing Processing Paradigm
Apr 01, 2015 By Randi Hernandez BioPharm International Volume 28, Issue 4 Although continuous manufacturing is well established for bulk chemicals, complex automation and validation …

Article Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain. Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…

Article A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
First is the industry’s interest in mechanistic modeling of biotech unit operations and the gradual move away from the traditional empirical models. Second is the focus on creating tools that can faci…

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