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pro vyhledávání: '"Souhardya, Roy"'
Autor:
Anurag S, Rathore, Srishti, Joshi, Neh, Nupur, Nikita, Saxena, Sanghati, Bhattacharya, Souhardya, Roy
Publikováno v:
International Journal of Biological Macromolecules. 227:124-133
Biosimilar manufacturers need to perform analytical and functional similarity assessments against the reference product. Successful demonstration allows for an abbreviated clinical path, thereby translating to affordable biosimilars. Current practice
Publikováno v:
Journal of Biotechnology. 290:33-43
Recombinant protein production by various host organisms is strictly regulated, which is determined mainly by host cell genetics and maintenance of process variables within desirable limits in a reactor. Since the process dynamics typically exhibit n
Neural network-based fingerprinting of monoclonal antibody aggregation using biolayer interferometry
Publikováno v:
Analytical and bioanalytical chemistry. 412(9)
Aggregates are widely accepted to be a critical quality attribute (CQA) for biotherapeutics and believed to impact product immunogenicity. Monitoring of aggregates is typically performed using multiple orthogonal tools as any single tool is unable to
Publikováno v:
Separation and Purification Technology. 238:116392
High concentration formulation is advantageous over conventionally used intravenous formulation. A model for the drift in the excipient concentration in the ultrafiltration/diafiltration (UF/DF) operation by including the flux of each of the species