Search results for " analysis"
Article
Unifying Continuous Biomanufacturing Operations
A 1998 analysis found that perfusion cultures can be in operation for up to six months (4). But that is just the upstream part of the process stream, so how long could end-to-end production processes …
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
This is commonly accomplished by nucleotide sequence analysis of the transgene-specific PCR products amplified from pooled cDNA.
• Assessment of integration patterns, which provides insight into p…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
While many analysis instruments can measure particle size distribution, to identify the nature of particulates in protein therapeutics, information about particle shape and morphology is necessary, sa…
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Predicting Progress in Protein Aggregation
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deuterium exchange mass spectrometry (HDX MS), are enabling the improved design, production, and …
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
… various methods such as previous experience, literature information, consultants, and knowledge gap analysis. Efforts will be made to close the knowledge gap. This process helps in identifying the c…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
…ors must manipulate by automating sample collection, preparation, method implementation, and results analysis (inline or online), enabling automated and continuous process control—sometimes thought o…
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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…
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Leveraging Data for Better Biopharmaceutical Process Control
…s in upstream processing, with mid- or near-infrared (MIR or NIR) spectroscopies, or some transition analysis and performance studies with ultraviolet (UV) and NIR spectroscopies used in downstream p…
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QbD Improves Cell-Culture Process Control
Using a QbD strategy that implements PAT offers the advantage of real-time process monitoring and, subsequently, quality control based on the application of multivariate data analysis and mathematical…
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Avoiding Investigational Failures and Discrepancies
An investigation equation has three essential and interdependent components: clarification, decision making, and plan analysis.
Clarification. An investigation should start by thoroughly examin…