OEL Fastrac Catalog

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Certolizumab Pegol, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.