Search results for " knowledge"
Article
Eliminating Residual Impurities Starts with a Strategic Plan
While building a knowledge base on residual impurities requires investment, that investment pays off in the long term because it enables risk-based residual impurity control and minimizes the need for…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
“The knowledge level for some of the required production techniques, such as the formulation of lipid nanoparticles, is still limited within the pharmaceutical industry. We can expect to accrue even m…
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
The inability to effectively manage process data and knowledge across the product lifecycle is arguably one of the biggest hurdles to progress across the industry as a whole. While this may seem surpr…
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Being Thorough When Transferring Technology
During tech transfer, methods, skills, technologies, and importantly, knowledge is transferred from the drug developer to another site or group, often a contract manufacturing organization (CMO). It’s…
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Tackling Analytical Method Development for ADCs
“The availability of analytical methods and product-specific knowledge that may lead to the addition of new assays (or replacement of older technologies) as a clinical candidate approaches licensure,”…
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Continued Process Verification for Biopharma Manufacturing
Preparation of the CPV plan has provided a basis upon which to build and share knowledge and initiate further clarifying discussion across the industry.
What is Continued Process Verification?
…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
Design space and design of experiments
The goal is to increase process knowledge by providing a mechanistic understanding of the relationship between process parameters, raw material attributes,…
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Assessing Manufacturing Process Robustness
The assessment process results in a heightened level of product and process knowledge, while substantially reducing the risk of potential failure.
Documents and methods
Based on the 20…
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Lessons Learned Accelerate Vaccine Development
…tigens that confer protection and, in the meantime, make sure bioprocess and analytical experts have knowledge of all existing and new platforms, according to D’Amore. He also notes that efforts are …
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Biopharma Advances Demand Specialized Expertise
The knowledge gap
BioPharm: In what areas do you see knowledge or expertise gaps in current biopharmaceutical companies? Why do these gaps exist?
Lorimer (Patheon Biologics): There is a gap in t…