Molecular Processing of Protein Based Biological Medicines

Flashcards covering key vocabulary and concepts related to the molecular processing, purification, and analytics of protein-based biological medicines.

Biotherapeutics

Medicines that are derived from biological sources, often proteins used for therapeutic purposes.

Critical Quality Attributes (CQAs)

Essential features that need to be considered to ensure the function and safety of biotherapeutics.

Upstream Processing

The initial phase in the production of biotherapeutics where living cells produce the desired protein.

Downstream Processing

The phase in bioprocessing that involves purification and analysis of biomolecules after they are produced.

Affinity Chromatography

A purification method that uses a specific interaction between a protein and a ligand to separate proteins based on their affinity.

Viral Clearance

Process to ensure product safety by eliminating viruses from biotherapeutics.

Biosimilars

Biological products highly similar to an already approved reference product, aimed at providing similar therapeutic effects.

Antibody Dependent Cellular Cytotoxicity (ADCC)

A mechanism of cell-mediated immune defense where antibodies mark tumor cells for destruction by immune cells.

Economic Considerations

Factors related to the financial aspects of developing therapeutic products, including R&D costs and market pricing.

Mass Spectrometry

An analytical technique used to measure the mass-to-charge ratio of ions, useful in characterizing proteins.