Search results for "validation"
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Transformative Medicines Challenge FDA and Manufacturers
FDA approved Spinraza with a number of post-approval study and quality assessment commitments, including programs to re-evaluate drug substance method validation data and acceptance criteria, to re-ex…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Stückler not only showed how the approach could be used for deeper process understanding in early process development, but also the benefits of mechanistic models at the process characterization, vali…
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The New World of Biopharmaceutical Manufacturing
Advantages of single-use technology include greater flexibility, reduced resources for cleaning and cleaning validation, and faster turnaround between products and batches, resulting in reduced capita…
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From Darwin to Recombinant Fc Multimers
…ineering batches to monitor manufacturing performance, and also contributed to the process control, validation, and regulatory activities.
The third day of the conference opened with the Pathoge…
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Advancing Single-Use Technology Through Collaboration
…f the potential risk to quality, as well as a lack of clear understanding of full qualification and validation requirements,” and documents such as this testing protocol aim to remove some of those m…
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Process Chromatography Selection for Downstream Processing Applications
are used for one campaign only, omitting the cleaning steps and the need for cleaning validation. There is a continuous development of new chromatography resins combining separation modes. One example…
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Perfusion in the 21st Century
Similarly, changes in market demand can be met more rapidly, while use of disposable equipment reduces capital investment, cleaning and validation costs, as well as equipment footprint. Perfusion is a…
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Single-use technologies in downstream process intensification
When using conventional chromatography solutions, cleaning and cleaning validation consumes a considerable amount of time and facility resources. Cleaning-in-place protocols are performed before, duri…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Late-phase development starts from the manufacture of product for the first registration dose (FRD) using commercial manufacturing processes and ends with process validation and submission of the prod…
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Tools for Continuous Bioprocessing Development
…on elements: use of contract manufacturers, for instance, and a manufacturer focus on discovery and validation. A key difference is that biopharmaceuticals are manufactured using living organisms, wh…