Search results for " analyze"
Article
Elucidating Biosimilars Characterization
Glycans are traditionally analyzed using either liquid-phase separation techniques such as liquid chromatography or capillary electrophoresis with optical or fluorescence detection or mass spectrometr…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
Following a manual deprotection of the siRNA product, reversed-phase high-performance liquid chromatrography (RP-HPLC) and liquid chromatography–mass spectrometry (LC/MS) are used to analyze the quali…
Article
PDA's Technical Report for Biotech Cleaning Validation
49: Points to Consider for Biotechnology Cleaning Validation, well–designed laboratory-scale studies can be performed using design of experiments, and the data analyzed to understand the cleaning proc…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
Article
Setting Up Bioprocessing Systems for Digital Transformation
Plant operators are applying AI and machine learning to analyze and predict equipment as well as plant health and performance using data from traditional sources and these new sources. “This multivari…
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Remote Monitoring and Big Data Advance Upstream Automation
“These systems integrate with metabolite analyzers and cell counters and can be used for fraction collection for product quality or direct integration with high-performance liquid chromatography instr…
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Reimagining Affordable Biosimilars
…ch as matrix-assisted laser desorption/ionization, electrospray ionization (ESI), and nano-ESI; mass analyzers such as quadrapole-time of flight (QTOF), triple quadrapole (QqQ), Fourier transform-ion…
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Methods Accelerate Biosimilar Analysis
With the introduction of more advanced software to analyze HDX–MS data, such as Deuteros (5), it is expected that HDX–MS will become a more widely used tool in the analysis of biosimilars for demonstr…
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Moving PAT from Concept to Reality
“Microfluidics-based analyzers require a small sample volume and provide higher resolution than existing PAT technologies,” he explains. He points to three additional microfluidics technologies—partic…
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…phy (RP–UHPLC), and normal phase (NP) or hydrophilic interaction chromatography (HIC), are used to analyze CQAs and detect impurities that are introduced by deamidation, isomerization, oxidation, and…