Bioavailability of Therapeutic Proteins by Inhalation—Worker Safety Aspects

A literature review and analysis of inhalation bioavailability data for large therapeutic proteins was conducted in order to develop a practical estimate of the inhalation bioavailability of these drugs. This value is incorporated into equations used to derive occupational exposure limits(OELs) to p...

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Bibliographic Details
Published in:The Annals of occupational hygiene 2014-08, Vol.58 (7), p.899-911
Main Authors: PFISTER, Thomas, DOLAN, David, BERCU, Joel, GOULD, Janet, WANG, Bonnie, BECHTER, Rudolf, BARLE, Ester Lovsin, PFANNKUCH, Friedlieb, FLUECKIGER, Andreas
Format: Article
Language:English
Subjects:
Biological and medical sciences
Biological Availability
Humans
Immunoglobulin G - metabolism
Inhalation Exposure
Lung - metabolism
Maximum Allowable Concentration
Medical sciences
Occupational Exposure - analysis
Occupational Exposure - standards
Occupational medicine
Pharmaceutical Preparations - analysis
Proteins - pharmacokinetics
Proteins - therapeutic use
Public health. Hygiene-occupational medicine
Safety
Threshold Limit Values
Workplace
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Summary:A literature review and analysis of inhalation bioavailability data for large therapeutic proteins was conducted in order to develop a practical estimate of the inhalation bioavailability of these drugs. This value is incorporated into equations used to derive occupational exposure limits(OELs) to protect biopharmaceutical manufacturing workers from systemic effects. Descriptive statistics implies that a value of 0.05, or 5% is an accurate estimate for large therapeutic proteins (molecular weight ≥ 40kDa). This estimate is confirmed by pharmacokinetic modeling of data from a human daily repeat-dose inhalation study of immunoglobulin G. In conclusion, we recommend using 5% bioavailability by inhalation when developing OELs for large therapeutic proteins.
ISSN:0003-4878
1475-3162
1475-3162
DOI:10.1093/annhyg/meu038