Search results for " validation" in Articles / App Notes
Article
Securing the Single-Use Supply Chain
Qualification and validation are, in fact, the critical criteria that must be met to achieve dual sourcing, according to Acucena. “To achieve dual sourcing, one must have documented evidence that a ch…
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Essentials in Establishing and Using Design Space
Preliminary understanding of the design space may occur at any time; however, it must be defined prior to Stage I validation (2). Waiting to develop the design space until Phase II assures the specifi…
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Developing a Robust Bioprocess Using Mechanistic Models
Regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) demand strict requirements on process characterization and validation studies and ask for a deep …
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Single-Use Technologies Prove Effective for Viral Vector Process Development
These technologies provide several advantages over stainless-steel systems, including reduced capital investment, elimination of cleaning in place (CIP), and cleaning validation. These advantages, acc…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
As process characterization and validation is not done at production scale but typically with bench-top systems, arguments must be found why a bench-top model should be representative for the producti…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Manufacturing change validation/product comparability studies:Necessary to re-validate process with starting material that is essentially indistinguishable from original material in terms of quality, …
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Addressing the Complex Nature of Downstream Processing with QbD
Malmquist believes designing viral safety into processes from the beginning is of “high value … delaying the testing to comprise validation and at the same time reducing the risk for surprises at late…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
Additional benefits will be providing a way to upskill the workforce and to focus on regulatory concerns, such as model validation and change management. Results and the white paper are due to be rele…
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New Column for Scale-Down Studies
Discover Validation Columns
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Nurturing Knowledge from Disparate Data Streams
“A method for plant operators to use for determining that a lot spectrum conforms to a standard should be rugged and allow for simple acquisition and validation. Ultraviolet (UV) analysis is one examp…