Search results for " design" in Articles / App Notes
Article
Impurity Testing of Biologic Drug Products
Now these guidelines are a little outdated, mainly with regards to biophysical methods but they still remain a good basis for the design of a characterization method panel. There are many ways to addr…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Gottlieb noted in early July 2017 that manufacturers have filed nearly two dozen requests for RMAT designation, and that CBER’s Office of Tissues and Advanced Therapies (OTAT) had granted four. Simila…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
With the advent of quality by design, there have been renewed efforts toward gaining a deeper process understanding through mechanistic modeling of key bioprocess unit operations.
Researchers have…
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Single-use Bioreactors Have Reached the Big Time
Significant advances in film technologies, bioreactor designs, stirring mechanisms, and sensor systems have contributed to the increasing adoption of disposable reactors from the lab to production sca…
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Establishing Acceptance Criteria for Analytical Methods
…aluate a method relative to the mean, evaluate it relative to the product specification tolerance or design margin it must conform to. This concept has been well established for many years in chemica…
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Perfusion in the 21st Century
These drugs are often produced in smaller, more flexible facilities that are designed to manufacture multiple products, and often involve the use of disposable equipment. Biosimilars manufacturers are…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
Generation 0 (G0) represents the generation of a master cell bank, G30 represents the generation of cells harvested from a 5000-L bioreactor, and G60 represents the limit for in vitro cell age designe…
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Best Practices in Qualification of Single-Use Systems
Typically, the development engineers at biopharmaceutical companies then work closely with the design engineers and application engineers from suppliers to select components and standard assemblies as…
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Selecting a Comprehensive Bioburden Reduction Plan
Understanding potential sources of contamination for a given facility and manufacturing process is key to planning for design, preventative maintenance, bioburden monitoring, and remedial actions. Eff…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
Advances in single-use technologies designed specifically for microbial systems may, however, lead to their greater use in the future.
Galliher agrees that single-use technologies are not a panace…