Search results for " risk mitigation"
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Risk Mitigation Strategies
BioPharm: What strategy does your company use to mitigate risk in the manufacture of biopharmaceuticals?
AstraZeneca: To obtain the most valuable risk mitigation pla…
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…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
This article proposes integrated solutions for systemic and proactive viral risk mitigation.
By Mark Plavsic
Use of continuous cell lines in the manufacture of biological therapeutic products, …
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
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Securing the Single-Use Supply Chain
Thus, risk mitigation can be achieved by using one vendor that has two plants or by using two separate vendors. “The latter option also provides some commercial leverage and tends to be the preferred …
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Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
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Application of Quality by Design to Viral Safety
Once the relative risk is established, then testing and other risk mitigation measures can be established.
The variety of potential contaminants for a given raw material should be understood in or…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
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Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
The platform can also formulate risk mitigation strategies for new or existing processes throughout the manufacturing lifecycle. The platform can be customized to meet specific customer needs.
“The…