Search results for " formulation"
Article
Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
Buffers of different formulations for a mAb chromatography capture step were prepared in an automated, consecutive manner, minimizing manual interactions. To further reduce the time and space required…
Article
Unifying Continuous Biomanufacturing Operations
…cur after the cell-secreted product is collected and purified: “For the purpose of equivalents the formulations may be lyophilized if desired. Thus, the invention encompasses production of lyophilize…
Article
Evaluating E&L Studies for Single-Use Systems
The main organic extractables identified were rubber and plastic materials formulation/manufacturing (polymer fragments, glycols, etc.) and additives (plasticizers, vulcanizing agents, lubricants, sol…
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Managing Risk in Raw Material Sourcing
By Agnes Shanley
Choosing excipients and suppliers for pharmaceutical formulations requires a clear understanding of product requirements; material properties; product, process, and material varia…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Although several serum-free and chemically defined nutrient media formulations are available for commercial use, many cell-culture applications require use of nutrient media supplementation with serum…
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Lessons Learned Accelerate Vaccine Development
High-throughput and single-use technologies are also being leveraged to accelerate key aspects of manufacturing processes, such as determination of appropriate media, resins for purification, formulat…
Article
Robust Optimization, Simulation, and Effective Design Space
Step Seven: Optimize the process and define the set points
When determining the recipe for a formulation or process (set points) there are two methods that can be used. The first is optimization, …
Article
Quality Systems Key to Lifecycle Drug Management
…n methods able to ensure the continued safety and efficacy of products after alterations in systems, formulations, or test methods.
These developments reflect the struggle for regulators trying t…
Article
Vaccine Development and Production Challenges Manufacturers
Researchers are looking for formulations that reduce cold-chain requirements, methods to boost process yield, and new approaches to document product quality.
Some global health advocates, however, …
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Options for eliminating the detrimental effects of bDtBPP include complete removal of TBPP from the formulation, controlling TBPP oxidation through modulation of film manufacturing parameters, or usin…