Search results for " formulation" in Articles / App Notes
Article
Design of Experiments for Analytical Method Development and Validation
DOE for method validation seeks to validate the analytical method for a range of concentrations so that changes in formulation or concentration will not require additional validation as they are chang…
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2014 Manufacturing Trends and Outlook
Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and …
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
• Formulation recipes can be considered fixed parameters (low or not critical); these parameters generally have relatively tight limits, which are justified during formulation development. Such a para…
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Essentials in Quality Risk Management
…maintained from phase to phase during drug development and manufacturing and changes in drug-product formulation, definition, analytical method, and associated process changes are understood and mana…
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Quality Considerations for Using AI in Bio/Pharma
Watch Sue and Siegfried answer the question: “My company is researching the possibility of using AI in the formulation of a new product. Are there any quality considerations we should be aware of?”
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Selecting Chromatography Resins for Bispecific Antibody Purification
Targeting enhancement with two active antibody arms makes bispecific antibodies (bsAbs) highly attractive for the treatment of cancer and other diseases. Their purification can be more challen…
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Report from the 6th International HTPD Conference
Since then, HTPD in chromatography applications has been well established among most biopharmaceutical companies but has also expanded to upstream and cell culture screening as well as to formulation …
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Digitalization: The Route to Biopharma 4.0
For formulation, a model for predicting volumetric concentration factor across single pass tangential flow ultrafiltration (SPTFF) can be used to develop real-time automated monitoring and a control s…
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Trace metals getting you down? Learn what’s really in your cell culture media
Heavy metal might have a place in your music playlist, but heavy metals should stay out of your cell culture media. Heavy metal impurities in your media can have a drastic effect on cell vi…
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Manufacturing mRNA for research and beyond
This eBook guides you in the practical aspects of setting up an mRNA research laboratory. Get insights on methods, materials, and workflows for mRNA synthesis and scale up.
Explore the mRNA…