Search results for " characterization" in Articles / App Notes
Article
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!
Article
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 …
Article
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…
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
This key characterization technology is lacking. I'm optimistic it will be developed in the next few years because there's such a pressing need and flow cytometry is getting closer from an optical sta…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Participants explored strategies for analytical method development, assay validation, product characterization, specification setting, and for establishing relevant manufacturing controls for these hi…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
A decision regarding freeze-thaw parameters must often be made prior to having sufficient amounts of the product available to assess process characterization at manufacturing scale, thereby necessitat…
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Modeling Bioreactor Performance
On a positive note, he points out that as standardization of reactor geometries for single-use systems occurs, the number of reactor geometries that require characterization is decreasing, which is cr…
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Biosimilars: Making the Switch Comes with Challenges
Application dossiers have to give a quality target product profile (QTPP) based on the characterization of multiple batches of the reference product. If necessary, the manufacturing process would be a…