Biosafety Levels, Biologic Control Categories).Īa amino acid AAV adeno-associated virus ADA Anti-drug antibody ADC antibody drug conjugate ADCC Antibody dependent cellular cytotoxicity ADME adsorption, distribution, metabolism and elimination ALL acute lymphoblastic leukemia ATC adoptive T-cell therapy ALARA as low as reasonably achievable APC Antigen presenting cell API active pharmaceutical ingredient ASO antisense oligonucleotide BA bioavailability BCC biologic control category BCMA B-cell maturation antigen BMS Bristol-Myers Squibb bsAb bispecific antibody BSL biosafety level CAR chimeric antigen receptor Cas9 CRISPR associated protein 9 CBI cyclopropabenzidole CD cluster of differentiation CDC Centers for Disease Control CDC complement dependent cytotoxicity CNS central nervous system COVID coronavirus disease CRISPR clustered regularly interspaced short palindromic repeats CRS cytokine release syndrome CT computed tomography CTLA-4 cytotoxic T lymphocyte-associated antigen 4 CYP450 cytochrome P450 Da Dalton DAMP damage-associated molecular pattern molecules DAR drug-to-antibody ratio DM1 mertansine DNA deoxyribonucleic acid DSEN dermal sensitizer notation E − early E2F E2 factor ECB exposure control band EG exposure guideline EGFR epidermal growth factor receptor EpCAM epithelial cell adhesion molecule EpoFc erythropoietin-Fc fusion molecule Fab antigen binding fragment Fc crystallizable fragment FcRn neonatal Fc receptor FDA Food and Drug Administration FPF fine particle fraction FIXa factor IXa FX factor X GHS Globally Harmonized System of Classification and Labelling of Chemicals GM genetically modified GM-CFS granulocyte-macrophage colony-stimulating factor GSD geometric standard deviation h hour HBEL health based exposure limit HER2 human epidermal growth factor receptor 2 HSV-1 herpes simplex type 1 IC50 half maximal inhibitory concentration ICH M7 International Council on Harmonization M7 guidance Ig immunoglobulin i.t. oncolytic viruses, biologics) and where other occupational exposure limit systems are more applicable (e.g. This manuscript also points out instances where historical exposure control banding systems may not be applicable (e.g. This manuscript reviews the available literature for emerging modalities (including oligonucleotides, monoclonal antibodies, fusion proteins and bispecific antibodies, antibody-drug conjugates, peptides, vaccines, genetically modified organisms, and several others) and provides considerations for occupational health and safety-oriented hazard identification and risk assessments to enable timely, consistent and well-informed hazard identification, hazard communication and risk-management decisions. As these new modalities progress, concern and uncertainty arise regarding their safe handling by the researchers developing them, employees manufacturing them and nurses administering them. As science reveals an enhanced understanding of biological processes, new therapeutic modalities are becoming important in developing breakthrough therapies to treat both rare and common diseases. In order to develop new and effective medicines, pharmaceutical companies must be modality agnostic.
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