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PHP/BP415 Biologics Technology Learning Objectives With Questions And Correct Answers Latest Version
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PHP/BP415 Biologics Technology LearningObjectives With Questions And Correct
Answers Latest Version
Name the FDA agencies that regulate biologics
The Center for Biologics Evaluation and Research (CBER)
Center For Drug Evaluation and Research (CDER)
2024
, List the categories of biologics regulated by the CDER (4)
1. Monoclonal antibodies for in vivo use
2. Novel proteins intended for therapeutic use (Ex: Cytokines, enzymes, and other novel proteins,
except those assigned to CBER (vaccines and blood products)
3. Immunomodulators
4. Products intended to mobilize, stimulate, decrease or alter in any other way the production of cells
in vivo (Growth factors, cytokines, and monoclonal antibodies)
Describe the process to generate a recombinant protein
Recombinant proteins are generated from recombinant DNA constructs, expressed and purified in the
laboratory
2 Types:
Naturally occurring proteins (ex: human insulin, IL-2)
**Fusion/ chimeric proteins (ex: etanercept)
**Combine functional portions of two different proteins
Distinguish between monoclonal and polyclonal antibodies
Polyclonal antibodies
2024
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