OEL Fastrac Catalog

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.

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 Pembrolizumab, just click the ADD TO CART button.

HBEL

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