Search results for "modeling"
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…
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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…
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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
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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…
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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. …
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ADC Development Robust Despite Lackluster Performance
ADC Development Robust Despite Lackluster Performance
Despite the disappointing therapeutic performance of ADCs thus far, the pipeline still boasts promising prospects.
By Feliza…
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Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
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Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…