Search results for " process" in Articles / App Notes
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Timelines are often built without an opportunity to identify crucial aspects of the process, perform range finding experiments, or optimize the process. Additionally, fears of making "process changes"…
Article
Application of Quality by Design to Viral Safety
Using this approach, products are developed with a thorough understanding of how the raw materials and manufacturing processes impact the eventual clinical performance of the final drug product. QbD f…
Article
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Continuous processing upstream has been around for decades as perfusion (e.g., fiber-based perfusion bioreactors for fused-cell hybridoma culture in the 1980s). But that’s essentially the only continu…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes changed dramatically once it was discovered in 1996 that a fatal disease (variant Creut…
Article
Going Small to Achieve Success on the Commercial Scale
The development of commercial-scale processes that consistently provide high-quality product that meets those specifications requires extensive examination of numerous process variables and potential …
Article
Fluid Handling in Biopharma Facilities
Fluid Handling Capabilities
BioPharm: What is the best way to determine which fluid handling capabilities are needed within a facility?
Butler (AdvantaPure): A good start is to overlay your proc…
Article
Enhancing Resins Addresses Purification Concerns
Resins have been seen as one tool that can address the purification needs of new COVID-19 vaccines as well as the existing challenges in the downstream processing of increasingly complex biologic moda…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
The process typically involves performing 100% spray coverage testing, rinse recovery testing, specific or non-specific analytical method qualification, surface sampling and recovery testing of the sa…
Article
Selecting a Comprehensive Bioburden Reduction Plan
By Randi Hernandez
There are multiple variables to consider in the reduction of bioburden, including the evaluation of microbes in a facility, in the manufacturing process, and in the materials us…
Article
Robust Optimization, Simulation, and Effective Design Space
Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
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