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Search results for "validation"

Article Microbiological Testing: Time is of the Essence
“The prevailing concern is that these alternative methods require extensive validation studies to demonstrate equivalency to traditional microbiological methods. The need for such extensive method val…

Article Selecting the Right Viral Clearance Technology
“An inadequate understanding of the clearance requirements can result in failure to hit the needed clearance targets and the need for additional validation studies or viral clearance steps. Alternativ…

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…

Article 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…

Article 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 …

Article 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…

Article 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…

Article 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, …

Poster Reduce Risk of Failure in Your Virus Clearance Study by Choosing Robust Scale-Down Chromatography Tools
These studies are an essential part of process validation and are critical to ensure drug safety. Viral clearance studies are usually performed using a scale-down model mimicking the large-scale proce…

Article 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…