Pembrolizumab is a humanized monoclonal anti-programmed cell death-1 (anti-PD-1) antibody (immunoglobulin (Ig)G4/kappa isotype with a stabilizing sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant deoxyribonucleic acid (DNA) technology. It is a PD-1 blocking antibody used to treat various types of cancer, including metastatic melanoma, non-small cell lung cancer (NSCLC), cervical cancer, head and neck cancer, and Hodgkin's lymphoma. It is indicated for the treatment of patients with unresectable or metastatic melanoma and for the adjuvant treatment of adult and pediatric (12 years of age and older) patients with stage IIB, IIC, or III melanoma following complete resection. Additionally, in combination with pemetrexed and platinum chemotherapy, it is indicated for the first-line treatment of patients with metastatic nonsquamous NSCLC with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
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 Pembrolizumab, just click the ADD TO CART button.
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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.