The Pharma Data
SEPTEMBER 8, 2021
TIB Molbiol excels in ultra-rapid assay development for emerging infectious disease, strongly demonstrated during the COVID-19 pandemic. The acquisition enables Roche to further expand the portfolio of currently over 45 CE-IVD assays and more than 100 research use assays on Roche`s LightCycler PCR instruments.
The Pharma Data
MARCH 20, 2021
A schematic of domain and functional organization of two of the major structural proteins of SARS-CoV-2, Nucleocapsid protein as a target viral antigen for assay development. Based on our discovery experiments, we decided upon nucleocapsid protein as our target antigen for assay development.
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The Premier Consulting Blog
OCTOBER 26, 2022
Definition of the manufacturing process description The Parenteral Drug Association defines the MPD as: A tool used to assist in execution of risk assessments, in the development of the Control Strategy, and for transfer of the process for commercial manufacturing.
Agency IQ
FEBRUARY 2, 2024
In its latest iteration, the soup-to-nuts guidance runs to 43 pages, including a section on definitions and abbreviations but excluding appendices. The current update expands the discussion on biomarker-guided therapeutic development and recent oncology study designs, in addition to a variety of less consequential updates throughout.
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