OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to agalsidase alfa (CAS RN 9025-35-8) and agalsidase beta (CAS RN 9025-35-8). Alpha-galactosidase A (α-galactosidase A) is an endogenous human enzyme that hydrolyses terminal a-n-galactose residues in oligosaccharides and galactolipids into more easily digestible monosaccharides and disaccharides. Two different human recombinant α- galactosidases have been developed for enzyme replacement therapy for Fabry disease. One is agalsidase beta produced in Chinese hamster ovary (CHO) cells and has been approved in Europe, the United States, and Japan. The other is agalsidase alfa generated in human fibroblasts and has been approved in Europe. The two agalsidase preparations are biochemically and structurally very similar, as they have the same amino acid sequence as the native enzyme.

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 Alpha-Galactosidase A, just click the ADD TO CART button.

HBEL

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