Search results for " characterization"
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Addressing the Challenges in Downstream Processing Today and Tomorrow
These reasons force sponsors to initiate extensive process characterization studies and to lock the production processes early in the clinical development program (41).
One new approach to genera…
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Current Techniques and Challenges Presented in Scaling Between Bioreactors
These tools require high quality characterization data of the use bioreactors. Stainless steel bioreactors merge with the described tools which may be a challenge for the upcoming years. However, when…
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Assessing Manufacturing Process Robustness
…ty can be detected, as recommended by FDA process validation guidance
closure of the characterization gaps that were not addressed during early product development and to meet QbD sta…
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Technology Innovations Improve Process Chromatography Performance
Although significant work has been done in upstream bioprocessing to remove bottlenecks through the implementation of single-use technologies, better characterization of raw materials, and the use of …
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Eliminating Residual Impurities Starts with a Strategic Plan
Depletion of such molecules in the final process design should, however, be confirmed during process characterization and process validation.
Many regulations
There are several relevant…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
A consortium has been established to help the industry better leverage MAM for product characterization as well as product release from QC, said Rogers, noting that it currently has more than 220 indi…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Four QA application areas stand out: (i) data analytics, (ii) bioprocess characterization, (iii) cell line engineering/development, and (iv) manufacturing bioprocess optimization and control.
Kine…
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Are You in Control of the Quality of Your mAbs?
Sign up to view an on-demand recording and receive a free copy of our poster booklet, Better Biotherapeutic Characterization for Improved Quality Control. Enjoy!
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An Analytical Approach to Biosimilar Drug Development
Although analytical scientists have long been immersed in the traditional field of small-molecule pharmaceuticals, they are increasingly required to shift focus to large-molecule characterization and …
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Nurturing Knowledge from Disparate Data Streams
“Orthogonal analyses are required to ensure full characterization. Chromatography may be used to determine purity, while other methods must be used to determine the identity (sequence, location of PTM…