Search results for "analytical" in Articles / App Notes
Article
Q&As with Industry Leaders
…ity
Jeanne Linke Northrop, Biopharm International
Mary Szorik, Senior Manager of Analytical Services, Cytiva
Alice Elwood, Analytical Services Product Manager, Cytiva
Chrom…
Article
Climate Change in Outsourcing
Strategic partnering opportunities in analytical services, clinical trial materials (CTM) manufacturing and clinical supplies management are still in their early stages, and the larger analytical labs…
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QbD and PAT in Upstream and Downstream Processing
As a result of major advancements in analytical science, direct measurements of CQAs are performed in bioprocessing today. These would be product-quality related parameters, including host-cell impuri…
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Quality by design for biotechnology products—part 1
Thus, to implement QbD, it is critical to have a fundamental understanding of the functional relationships between patient needs, product quality attributes, analytical capabilities, and the manufactu…
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Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
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Report from the 12th Plasma Product Biotechnology Forum
The general trend was considered more interesting than specific values predicted, as scale-up and variability of analytical methods were not considered.
Another aspect of technical development …
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Interest rose in innovative clinical research methods, such as master protocols, adaptive trial designs, and Bayesian analytical methods to reduce study size and duration. Digital technology was adopt…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
The company’s Accelerator Process Development Services group can, she says, provide robust industrial-scale processes, including the development of a process analytical technology (PAT) approach, in s…
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Emerging Therapies Test Existing Bioanalytical Methods
Challenges remain for development of these therapies, particularly in the bioanalytical method approach required. Questions include the following:
· How much of a dosed gene therapy is present in …
Article
Protein Analysis with Size Exclusion Chromatography
This white paper presents fundamentals about analytical SEC and describes how our new-generation agarose-based SEC columns are used in analysis of biomolecules.
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