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Key terms
| Biomarker: | A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives. Categories of biomarkers include: susceptibility/risk biomarker, diagnostic biomarker, monitoring biomarker, prognostic biomarker, predictive biomarker, pharmacodynamic/response biomarker, and safety biomarker (26). |
| Qualification: | A conclusion based on a formal regulatory process, that within the stated context of use, a medical product development tool can be relied upon to have a specific interpretation and application in medical product development and regulatory review (26). |
| Immunogenicity: | The ability of a substance, including a biotherapeutic, to elicit an immune response in vivo which results in an induction of anti-drug antibodies, antigen specific T cells - among others. For the purposes of this article, ADA assays are equivalent to immunogenicity assays. |
| Cut point: | The cut point of the assay is the level of response of the assay that defines the sample response as positive or negative (53). |
| Context of use: | A statement that fully and clearly describes the way the medical product development tool is to be used and the medical product development-related purpose of the use (26). |
| Acronyms | |
| AAV: | Adeno-associated virus |
| ADA: | Anti-drug antibody |
| ASO: | Antisense oligonucleotide |
| ASR: | Analyte specific reagents |
| BA: | Bioavailability |
| BAV: | Biomarker assay validation |
| BE: | Bioequivalence |
| BEAD: | Biotin-drug extraction and acid dissociation |
| BLA: | Biologics license application |
| BMV: | Bioanalytical method validation |
| CAR-T: | Chimeric antigen receptor T cell |
| CCP: | Confirmatory cut point |
| CDx: | Companion diagnostics |
| CLIA: | Clinical laboratory improvement amendments |
| CLSI: | Clinical Laboratory Standards Institute |
| COU: | Context of use |
| CPF: | Concentration, purity and functionality (new acronym in the context of reagent characterization) |
| CRISPR: | Clustered regularly interspaced short palindromic repeats |
| CRO: | Contract Research Organization |
| CSF: | Cerebrospinal fluid |
| DBS: | Dried blood spots |
| ECD: | Extracellular domain |
| ELISPot: | Enzyme-linked immunospot |
| F/P Ratio: | Fluorochrome to protein ratio |
| FFP: | Fit-for-purpose |
| FMO: | Fluorescence minus one |
| FPR: | False-positive rate |
| GCLP: | Good Clinical Laboratory Practices |
| GCP: | Good Clinical Practice |
| GLP: | Good Laboratory Practice |
| GMP: | Good Manufacturing Practice |
| GxP: | Good Practices where x = clinical, laboratory or manufacturing |
| GTx: | Gene therapeutics |
| HDR: | Homologous directed repair |
| HRMS: | High-resolution mass spectrometry |
| HSV: | Herpes simplex virus |
| IA: | Immunoaffinity |
| IDE: | Investigational... |