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Roche signs definitive share purchase agreement with long-term partner TIB.

The Pharma Data

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.

Virus 52
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Brochure: Dynabeads manual and automated SARS-CoV-2 enrichment

The Pharma Data

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.

Virus 52
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Tech Transfer Tools: The Requirements and Uses of Manufacturing Process Descriptions

The Premier Consulting Blog

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.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

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.