Certolizumab pegol is a recombinant, humanized antibody fragment antigen-binding (Fab) fragment. The Fab fragment is manufactured in Escherichia coli and is subsequently purified and conjugated to polyethylene glycol (PEG) via a maleimide linker. The light chain is composed of 214 amino acid residues, and the heavy chain is composed of 229 amino acid residues. The molecular formula of certolizumab pegol is C2115H3252N556O673S16, with a molecular mass of 90.8 kDa. Since certolizumab pegol is composed of different amino acid fragments, further physical and chemical characteristics are not applicable for certolizumab pegol.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
To order an OEL/ADE monograph for Certolizumab Pegol, just click the ADD TO CART button.
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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.