Search results for " HCP assay"
Article
Challenging Host Cell Protein Assays for Improved Risk Mitigation
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This webinar shares Cytiva’s strategy for designing a comprehensive host cell protein (HCP) risk mitigation strategy. We will address how to challenge your assays ea…
Article
Why, Why, Why…ELISA? A Look at the Benchmark HCP Assay
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Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytica…
Article
Host-Cell Protein Measurement and Control
The development cycle for an in-house HCP assay is shown in Figure 2 following the flow of green arrows. Commonly, platform- or process-specific HCPs are generated by growing a null cell culture (mock…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.
By Cynthia A. Challener
Manufacture of protein and other biologic drug substances via …
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Manage HCPs and Enhance Your Route to Market
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Host cell protein (HCP) management is critical to biologics development—and getting it wrong could delay your development cycle. Learn how the right HCP strategy can enhance…
Article
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
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Process analytical technology (P…