Search results for " design"
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Technology Innovations Improve Process Chromatography Performance
It is of great importance to rely on materials, such as resins, buffers and equipment, which are designed for production purposes and available in the amount they are needed,” he states.
“The othe…
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The Importance of Partnering for Bioanalytical Studies
…ss of a new biological therapeutic?
Bose (Emery Pharma): Bioanalytical studies, which are designed to provide estimates for concentration of drugs and biologics in pre-clinical and clinic studi…
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The Need for Advanced Process Modeling for New Therapeutic Biologics
While QbD does not define manufacturing design space or specific protocols, it does discuss the need for a systematic approach to drug development and manufacturing. FDA believes that a QbD approach, …
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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Now these guidelines are a little outdated, mainly with regards to biophysical methods but they still remain a good basis for the design of a characterization method panel.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…