Search results for "risk analysis"
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
A risk analysis can help determine which components and equipment may introduce the largest amount of risk. Steps with higher risks may also warrant an on-site audit to truly understand all facets of …
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Finally, a qualitative risk analysis or a formal failure mode effects and criticality analysis (FMECA) was conducted for each of the identified process parameters. The purpose of this assessment is to…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
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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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Application of Quality by Design to Viral Safety
Risk analysis and scientific characterization identify those components that will have the biggest effect on process consistency and CQA.
Identification of a multivariate design space in which dat…
Article
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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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…
Article
Selecting a Comprehensive Bioburden Reduction Plan
During a risk analysis, the process or environment is assessed for potential types of contamination. If components or equipment are different for processes, such as microbial fermentation and mammalia…