Search results for " knowledge"
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions at the outset and having the depth of experience and knowledge to understand the consequences of the answers are vital to establishing the right specifications during the de…
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Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
…tors to characterize? Historically, figuring which factors to characterize has relied heavily on the knowledge of process experts. MVDA provides tools for summarizing complex process data, which can …
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
…’s “TAG” system for digitally managing the capture, conveyance, and retention of manufacturing knowledge to improve technology transfer, which provides controlled publication and distribution of manu…
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Applying GMPs to the BioPharma Supply Chain
Comprehensive (and electronic) information and knowledge flow
Suppliers need to understand that product and process data over and above that shown on a certificate of analysis are needed by end us…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Conversely, the more novel the protein is, the less opportunity there may be to apply knowledge across products.
After assigning an impact score, the team then evaluates the quantity and relevanc…
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Implementing QbD in Sterile Manufacturing
Even if challenges as previously described appear in the early stages, the gained knowledge will likely result in an economic benefit in the long-term commercial lifecycle.
Benefits of QbD
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The Development and Application of a Monoclonal Antibody Purification Platform
Based on knowledge gained from the implementation of the original process, and modified processes 2 and 3, the load capacities, buffer solutions, and other operational parameters were standardized to …
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Essentials in Quality Risk Management
As we complete development activities, the risk goes down because our knowledge and understanding of the factors associated with unit operations and analytical methods go up relative to product accept…
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Advancing QbD in the EU
This knowledge becomes a basis for achieving quality by ensuring pre-defined quality criteria are met through design rather than ad-hoc testing. However, EMA has not been a strong driving force behind…
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The Lifecycle Change of Process Validation and Analytical Testing
In addition, they provide effective knowledge-management tools, providing information that can be utilized for future validation activities.
Jones (Innopharma Labs): I think PAT technologie…