Search results for " method" in Articles / App Notes
Article
Biosimilar Quality Requirements
Effective Analytical Methods
High-resolution mass spectrometry (HR–MS) is the go-to method for primary structural analysis and characterization of complex protein molecules, particularly following…
Article
Witnessing Major Growth in Next-Generation Antibodies
For next-generation products, delivery methods that give the best therapeutic effects, safety profiles, and convenience for the patient, the latter becoming increasingly important, should be the goal,…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
A written emergency (contamination) response plan is an important part of the SbD method. The objective of a viral response plan is to specify necessary steps in the response process, delineate clear …
Article
Lessons Learned Accelerate Vaccine Development
Early bioprocessing challenges
The diversity of viruses that cause diseases, the number of different vaccine products, and the variety of vaccine production methods all contribute to the complexit…
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Use of Multivariate Data Analysis in Bioprocessing
COadReS and ACO are variable selection methods that are used to enhance the predictive ability of the chemometric model by removing unnecessary spectral information. In yet another application, resear…
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Single-Domain Antibodies for Brain Targeting
…th binding activity using phage libraries, such as in the case of human VH domain antibodies (21), a method that enables also cost-effective production (see Table I).
Given their high affinity an…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
For process validation Stage 1 process characterization studies, analytical methods for measuring CQAs may not yet be fully validated, but still, must be scientifically sound.
The level of accur…
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Reviewing the Importance of Biosimilarity and Interchangeability
Analytical methods should thus be chosen or developed to compare critical quality attributes (CQAs) between the biosimilar and the reference product. “This involves assessing the physicochemical prope…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
This method also eliminates any on-site powder kitting process steps while reducing hours required per buffer batch to almost a third of the typical process.
An equally effective approach l…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Novel techniques including Raman spectroscopy and other advanced monitoring methods have the potential to reduce the reliance on discrete sampling points for off-line analytics such as titer measureme…