Search results for "analytics" in Articles / App Notes
Article
Setting Up Bioprocessing Systems for Digital Transformation
…lead, Biologics; John Liddell, chief technologist, Biologics; Lukas Kuerten, senior scientist, Data Analytics; and Sean Ruane, scientist, Downstream. There is also the issue with data tracking, so th…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Article
Reconciling Sensor Communication Gaps
For Kelsey McNeel, market segment manager, process analytics at Hamilton (Reno, NV), the key issue for bioprocess monitoring and controls is reconciling information obtained at bench- or process-devel…
Article
Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing.
By Cynthia A. Challener
Vaccine development is a complicated process that can take many yea…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
Article
2014 Manufacturing Trends and Outlook
Protein aggregates, formulation issues, creating/cloning cell lines, regulatory issues, and analytics were mentioned by more than 25% of the respondents (see Table I).
Nucleic-acid based drugs.…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Article
Moving Biosimilars Forward in a Hesitant Market
The biosimilars landscape is growing as market factors, such as pricing pressure, advanced bioprocessing and analytical technologies, and upcoming patent expirations for innovator biologics dr…
Article
Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com
The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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