Search results for " techniques"
Article
Reviewing the Importance of Biosimilarity and Interchangeability
“The evaluation of process-related impurities, such as residual solvents, reagents, and by-products, should be performed using appropriate analytical techniques,” he adds.
Meanwhile, stability stu…
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Digitalization: The Route to Biopharma 4.0
As a result, simple data-driven, dynamic process models that are based on various machine learning techniques are more commonly used in the industry. Over the past decade, manufacturers have been incr…
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Fundamentals of hydrophobic interaction chromatography
Hydrophobic interaction chromatography (HIC) is a versatile technique that can be used for capture, intermediate purification, or polishing steps.
This technique separates proteins accor…
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Good Modeling Practice
Standard model calibration techniques may result in unreasonable correlations and unrealistic physical parameter estimates. But how can we mitigate this risk, improve the model’s quality, and reduce t…
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New hydrophobic interaction chromatography (HIC) handbook
Hydrophobic interaction chromatography (HIC) separates biomolecules under mild conditions according to differences in molecular hydrophobicity. HIC is often used as a next step to purify prote…
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Enhancing Resins Addresses Purification Concerns
“There are several purification techniques that are in use, such as precipitation, tangential flow filtration, or chromatographic separations. However, precipitation or size-exclusion chromatography (…
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Assessing Manufacturing Process Robustness
Criticality assignment (Step 2)
Upon identifying the risk factors through cause-and-effect techniques, a risk-rating decision tree (Figure 3) is used to analyze the process upon risk asse…
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Setting Up Bioprocessing Systems for Digital Transformation
This is an area where AI, in conjunction with online and rapid offline PAT techniques and digital twinning, will allow real-time process, Kuerten explains.
Legacy transformation
In terms of a …
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Sharing of best practices and potential new analytical techniques at early stages of development can be very powerful.
All stakeholders in the industr…
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Typical Purification Protocols to Obtain the Right Purity and Yield
Our free digital guide helps you effectively combine the main chromatography techniques to obtain a powerful purification protocol.