Search results for " information"
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Your Source of Information for Automated Multistep Protein Purification
Cytiva has gathered recourses to support automated multistep purification such as information on how to get started, what other scientists are working on, instructions, and more.
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Understanding Validation and Technical Transfer, Part 3
A consultation document [2]published by the European Commission (3) and an FDA guidance document on human somatic cell therapy and gene therapy (4) provide useful information for developing validation…
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Labeling of Biosimilars
“The general principle is that the SmPC for a biosimilar medicine has to be consistent with the reference medicinal product for the common information applicable to the biosimilar product,” explains a…
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Biosimilar Quality Requirements
The document also provides recommendations to sponsors on what scientific and technical information to include for the chemistry, manufacturing, and controls (CMC) section of a marketing application f…
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Tackling Analytical Method Development for ADCs
…(size-exclusion chromatography [SEC], SEC-multi-angle laser light scattering (SEC-MALLS) can provide information about the number and location of conjugation sites, average DAR, and free drug content…
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Nurturing Knowledge from Disparate Data Streams
A nuclear magnetic resonance (NMR) spectrum provides a significant amount of detailed information about a given molecule and is therefore attractive for small-molecule API proof-of-structure analysis.…
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Use of Multivariate Data Analysis in Bioprocessing
To achieve this, a tool that can effectively deal with these complexities and extract the relevant information from these highly correlated multivariate data sets is required. Multivariate data analys…
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Successfully Moving Regulated Data to the Cloud
But as organizations have moved to new systems where all of the data are captured and documented electronically with the use of software such as electronic laboratory notebooks (ELNs) and laboratory i…