Search results for " screening"
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
By Catherine Shaffer
Four biosimilars have been approved for the market by FDA as of February 2017, and more are in the pipeline. Now that biosimilars are here to stay, manufacturers are devel…
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…
Article
Increase Efficiency in Experimentation with Design of Experiments
Setting up an efficient study can help you save time and allow you to get the most out of screening and optimization experiments during method development. Also, good planning and relevant experimen…
Article
Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
B…
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Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…
Article
Lessons Learned Accelerate Vaccine Development
“Quality by design, high-throughput screening, high-throughput sequencing, small-scale models to simulate large-scale production, artificial intelligence (both simulation and predictive models), and m…
Article
Developing Cleaning-in-Place Protocols
Cleaning conditions for chromatography media can be screened in a couple of working days using 96-well microtitre plate formats. A study with a Protein A resin illustrates the approach in this appli…
Article
Antibody Production in Microbial Hosts
Aglycosylated antibody fragments showing selective binding to FcγRIIa were isolated by yeast surface display and flow-cytometry screening. In another study, researchers employed a knob-into-hole techn…
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Robust Optimization, Simulation, and Effective Design Space
Main effects only and/or screening type experiments will not result in a robust solution.
Step Eight: Evaluate the set points using the design space
Once the set points have been selected, the vis…
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…