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…