Search results for "analytics"
Article
Report from the 6th International HTPD Conference
Analytics is still a challenge in HTPD work
The challenge of having access to sufficient high-throughput analytical technologies has been a repeating topic during the HTPD conference series. Ja…
Article
Maximum Output Starts with Optimized Upstream Processing
…um and thus ultimately impacting upstream bioprocessing capacity: continuous manufacturing, process analytics, and radically improved downstream purification. “There is a real shift,” agrees Chilima,…
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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…
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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…
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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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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…
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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…
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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 …
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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.…
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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…