OEL Fastrac Catalog

Risankizumab is a fully humanized IgG1 mAb directed against interleukin (IL)-23. Risankizumab is used to treat moderate-to-severe plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn's disease. Risankizumab is a humanized immunoglobulin (Ig)G1 monoclonal antibody (mAb) selective to the interleukin (IL)-23 protein produced in Chinese hamster ovary (CHO) cells using recombinant deoxyribonucleic acid (DNA) technology. Risankizumab is composed of two heavy chains and two light chains. The heavy and light chains are covalently linked by a single disulfide bond, and the heavy chains are linked to each other by two disulfide bonds. Each heavy chain contains a single N-linked glycosylation site. Based on the amino acid sequence, the molecular formula of the disulfide bonded risankizumab molecule without post-translational modifications is C6476H9992N1720O2016S44. The predicted molecular weight of aglycosylated risankizumab is approximately 146 kDa.

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 Risankizumab, just click the ADD TO CART button.

HBEL

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