Considerations for setting occupational exposure limits for novel pharmaceutical modalities

Regul Toxicol Pharmacol. 2020 Dec;118:104813. doi: 10.1016/j.yrtph.2020.104813. Epub 2020 Nov 2.

Abstract

In order to develop new and effective medicines, pharmaceutical companies must be modality agnostic. 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. 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. 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. This manuscript also points out instances where historical exposure control banding systems may not be applicable (e.g. oncolytic viruses, biologics) and where other occupational exposure limit systems are more applicable (e.g. Biosafety Levels, Biologic Control Categories).

Keywords: Engineered bacteria; Exposure control band; Occupational exposure limit; Occupational health; Oncolytic virus; PET Tracer; Pharmaceutical modalities; Protein therapeutic; Vaccine safety; Worker safety.

Publication types

  • Review

MeSH terms

  • Bacteria / genetics
  • Biological Products / adverse effects*
  • Biological Products / pharmacokinetics
  • Decision Trees
  • Drug Industry*
  • Humans
  • Occupational Exposure / adverse effects*
  • Occupational Exposure / prevention & control
  • Occupational Health
  • Oligonucleotides / adverse effects
  • Oncolytic Viruses / genetics
  • Pharmaceutical Preparations*
  • Proteins / adverse effects
  • Radiopharmaceuticals / adverse effects
  • Risk Assessment
  • Safety Management
  • Vaccines / adverse effects

Substances

  • Biological Products
  • Oligonucleotides
  • Pharmaceutical Preparations
  • Proteins
  • Radiopharmaceuticals
  • Vaccines