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.
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 Alpha-Galactosidase A, just click the ADD TO CART button.
If you're wondering about HBEL, we have something for you.
Not the compound you were looking for? You can search the OEL Fastrac catalog to find more available compounds.
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.