Search results for " activity" in Articles / App Notes
Article
Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
Roadmap Leads to Innovative Biomanufacturing Strategies
The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
By Feli…
Article
Reducing Cross-Contamination Risks in Process Chromatography
Reducing Cross-Contamination Risks in Process Chromatography
Single-use systems provide replaceable fluid paths.
By Cynthia A. Challener
…
Article
Platform Technologies Improve Protein Expression
“These approaches offer avenues for designing better fit-for-purpose molecules not only in terms of their activity and safety, but also with respect to desirable CMC attributes,” says Voldborg.
Th…
Article
Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
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Fusion Proteins Pose Manufacturability Challenges
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues.
By Cynthia A. Challener
Fusion proteins are engineered proteins that contain domains from di…
Article
Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
Article
Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
(38), wherein slow thawing conditions caused higher protein degradation and loss of activity (38).
One key finding from this work is that fast freezing followed by slow thawing resulted in g…
Article
Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…