Search results for "modeling" in Articles / App Notes
Article
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
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Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
Article
Scalable Viral Vector Manufacturing
The interest for robust and scalable viral vector manufacturing is rapidly increasing, with the recent developments of both cell and gene therapy and oncolytic virus-based therapies. As cost pressur…
Article
Digital Technologies Aid Productivity and Growth
By applying remote monitoring solutions, advanced modeling, and optimization of manufacturing processes, digitalization can offer improved process reliability and product quality through the unlimited…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Molecular modeling with a core fucosylated RapiFluor-MS labeled N-glycan suggested that rigidity of the label likely caused steric clashes within the BKF active site (13). However, this problem has be…
Article
Process Economic Simulation for Scalable Production of Adenovirus
This application note discloses the process economic modelling of a modern start-to-finish adenovirus production process. The novel process was compared with a reference process in both stainless-st…
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
Article
Industry Adoption of Single-Use Systems Remains Low
Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
By Feliza Mirasol
zli…
Article
FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
Article
Performance of Single-Use Xcellerex™ XDR‑500 MO and XDR‑50 MO Stirred-Tank Fermentor Systems
This application note describes the performance of the XDR‑500 MO fermentor system in comparison with the XDR‑50 MO fermentor. Domain antibody production in E. coli was used as the model process. …