Search results for " Lifecycle"
Article
Modular Manufacturing Platforms for Biologics
Traditional structures are designed for one product lifecycle, whereas pods have a lifespan of more than 20 years and can be repurposed or relocated, he attests. Other benefits of pods include compact…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
OPQ’s lifecycle review initiative and its team approach for integrating quality review and compliance aim to support accelerated review of a growing cadre of breakthrough drugs.
Changes in OPQ’s O…
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Quality by Design and Extractable and Leachable Testing
Finally, there is lifecycle management and continual improvement. It is important to partner with the material supplier to understand potential changes in their processes. A vendor quality agreement w…
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Viral Clearance Challenges in Bioprocessing
This discussion is additionally stimulated by the fact that viral clearance studies are required at different stages of the product lifecycle, from before the clinical phase through more comprehensive…
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Application of Quality by Design to Viral Safety
QbD functions across the lifecycle of the product and integrates sound science with risk management. This approach uses the concepts laid out in the International Conference on Harmonisation of Techni…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Challenges in Analytical Method Development and Validation
Quality by Design
BioPharm: How can method validation benefit from a QbD approach?
Krause (MedImmune): For a QbD approach for analytical methods, the analytical method lifecycle stages should co…
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Quality by Design—Bridging the Gap between Concept and Implementation
…technology, perceptions of high regulatory hurdles, and the absence of a procedure to manage complex lifecycle management changes, said the speakers. Above all, they added that there is “a lack of an…
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Manufacturers Struggle with Breakthrough Drug Development
The plan should consider how estimated market demand would relate to manufacturing facilities, lifecycle process, methods validation, and stability studies. Early submission of CMC information will al…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
More than ever, they will need to make sure that prospective assets address unmet needs, and offer meaningful differentiation that is sustainable over the product’s lifecycle.
• R&D will need to de…