Search results for " risk assessment"
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The fact that a highly critical attribute is easily controlled through the process, even to the point of not requiring routine testing, should be captured separately in process risk assessments and in…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The genetic stability studies are performed in two phases: the mid-phase study, referred to as the “genetic stability risk assessment,” which evaluates the integrity and stability of the expression co…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
An initial risk assessment was then completed to determine a preliminary continuum of criticality for process parameters.
In Part II, the preliminary risk levels of process parameters provid…
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Eliminating Residual Impurities Starts with a Strategic Plan
“The risk assessment should aim at identifying and assessing those molecules where an element of risk may remain even at very low concentration, with potential risk evaluated in a multi-stage approach…
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Quality by design for biotechnology products—part 1
Prior product knowledge plays a key role in the risk assessment and consists of the accumulated laboratory, nonclinical, and clinical experience for any specific product quality attribute. It also can…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
This initial risk assessment is performed prior to the baseline characterization work and can be used as the primary means of determining the criticality of process parameters under the following cond…
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Application of Quality by Design to Viral Safety
Ensuring safety from such contaminations can involve risk assessments, testing raw materials for viral contaminants, and treating raw materials to reduce the risk of viral contaminants.
Each biolo…
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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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Being Thorough When Transferring Technology
If risk assessments have been performed on the process, these are a good starting point for understanding where the risks lie during tech transfer. However, the tech transfer process itself presents n…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Hutchinson: A suitable risk assessment tool should be used to assess the likelihood of bioburden becoming problematic. Process maps showing process inputs can be constructed and the risk of these cont…