Search results for " information" in Articles / App Notes
Article
Automating the Biomanufacturing Process
As a result, data integration is needed to handle the huge increase in product data from this growth to ensure that these raw data become information that can be used to control and improve the proces…
Article
Applying GMPs in Stages of Development
The information documented in change control and as part of an investigation helps ensure that process improvements are efficient and do not repeat strategies that were discounted during earlier stage…
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Reconciling Sensor Communication Gaps
For Kelsey McNeel, market segment manager, process analytics at Hamilton (Reno, NV), the key issue for bioprocess monitoring and controls is reconciling information obtained at bench- or process-devel…
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Efforts Accelerate to Streamline Postapproval Change Process
Varying regulatory and data requirements in each nation means that approximately 140 regulatory bodies review the same core data and information over and over again, following 140 separate timelines, …
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Ligand-Binding Assays and the Determination of Biosimilarity
Physicochemical assays for testing of originator and biosimilar molecules, however, can only assess the actual structure of the molecules, and do not provide information on the functional conformation…
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New Era for Generic Drugs
Block reviews aim to reduce repeated efforts, promote information sharing, and produce more consistent decisions.
CDER also is working hard to cut the massive backlog of some 5000 generic-drug manu…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
By evaluating attribute criticality solely on the basis of impact and uncertainty, the product risk assessment only needs to be revised when new information is discovered regarding the biology or toxi…
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Manufacturers Struggle with Breakthrough Drug Development
Early submission of CMC information will allow for timely review and for FDA to determine if the potential manufacturing site will require inspection, especially when contract manufacturers are involv…
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Regulatory Challenges in the QbD Paradigm
Implementation of quality by design (QbD) in this environment has further contributed to the need to clarify what information needs to be included in a regulatory filing and how it should be presented…
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Digitalization: The Route to Biopharma 4.0
This exercise involves integrating information flow, manufacturing, and automation to deliver an optimal commercial process (1).
Digitalization is fuelling the shift from paper-based records to…