Search results for " methods"
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Those technologies include more productive cell lines, single use, and powerful analytical methods.
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical indus…
Article
Single-use Bioreactors Have Reached the Big Time
Film validation using harmonized methods will, in the future, establish a framework for comparison and validation of product contact films for a process, reducing time and effort for the user, notes O…
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Tools for Continuous Bioprocessing Development
Hung, Methods Cell Biol. (102), pp. 77–103 (2011).
29. K.S. Lee et al., Lab on a Chip (11), pp. 1730–1739 (2011).
30. N.J. Mozdzierz at al., Lab on a Chip (15), pp. 2918–2922 (2015).
31. N. …
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
By Michiel E. Ultee, PhD, Dr. Richard Easton
This article reviews the implications of cell-culture co…
Article
Best Practices in Qualification of Single-Use Systems
In addition, pretreatment methods such as steam sterilization, e-beam irradiation, gamma irradiation, vaporized hydrogen peroxide, and ethylene oxide could have an effect on the properties of the poly…
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Breakthrough Drugs Raise Development and Production Challenges
Manufacturers need to decide dosage form and methods validation strategies much sooner, he said at the CMC workshop, and should “plan for the unexpected,” such as facility qualification failures and c…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Multiple risk identifying methods are maintained on an ongoing basis. To account for changes in the business environment, previously accepted risks are periodically reviewed to determine if mitigation…
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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
Biopharma Advances Demand Specialized Expertise
With this in mind, substitution of HPLC for UPLC, rapid microbiological screening methods, and investment in automated approaches to complex analytical problems such as protein sequencing are now bein…
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Modern Manufacturing Systems Key to FDA Quality Initiative
The agency seeks clearer standards and policies that provide more predictability and reduced oversight of firms that invest in more efficient production methods. At the same time, more transparent com…