Search results for " analytics"

Article Report from the 6th International HTPD Conference
The biggest challenge is still the people and Quantitative Structure-Activity Relationship (QSAR) plus mechanistic modeling were two key take-home messages from the 6th International conference devote…

Article Maximum Output Starts with Optimized Upstream Processing
…rum and thus ultimately impacting upstream bioprocessing capacity: continuous manufacturing, process analytics, and radically improved downstream purification. “There is a real shift,” agrees Chilima…

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 t…

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. …

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…

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