Search results for " characterization"
Article
Preclinical Evaluation of Product Related Impurities and Variants
Second, isolating individual variants in amounts that are sufficient for further analytical characterization that is required for assignment of the modifications or performing a cell based assay for d…
Article
N-Glycan Analysis of Biotherapeutic Proteins
The impact of glycosylation on protein function means that glycosylation can be a critical quality attribute (CQA), making the characterization of N-glycan structures an essential part of the biothera…
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Managing Residual Impurities During Downstream Processing
USP, in collaboration with its Expert Committee and Panel members, develops public standards that support the development, characterization, and release of therapeutics. USP monographs and associated …
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Several spectroscopic non-destructive techniques, including Fourier Transform Infrared (FT–IR), near-infrared (NIR), and Raman spectroscopy have been used for the identification and characterization o…
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Going Small to Achieve Success on the Commercial Scale
Unlike initial processes that are used during the discovery and early development phases to produce material for characterization, efficacy, safety, and other studies, scale-down models are intended t…
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Host-Cell Protein Measurement and Control
Supplementary to HCP ELISA, traditional HCP separation and visualization methods, such as 1D and 2D sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), remain useful tools for HCP ch…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
The purpose of this assessment is to provide a focus for the downstream process characterization work required to complete process validation Stage 1 (process design).
This initial risk assessm…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
As molecules progress through the clinical phase and begin gearing up for commercial submissions, the amount of development and characterization may increase and many experiments must be repeated, add…
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Quality by design for biotechnology products—part 1
This knowledge is gained during development and grows with more manufacturing experience through process characterization, scale-up, technology transfer, and manufacture, as well as through increased …
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
One of the most important strategies manufacturers need to implement is investing significant resources early on for intensive product testing and characterization, including characterization of apher…