OEL Fastrac Catalog

Peginterferon alfa-2a, also known as pegylated interferon alfa-2a, is a covalent conjugate of recombinant alfa-2a interferon with a single branched bis-monomethoxy polyethylene glycol (PEG) chain. Interferon alfa-2a is produced biosynthetically using recombinant DNA technology and is the product of a cloned human leukocyte interferon gene inserted into and expressed in Escherichia Coli. Peginterferon alfa-2a is indicated, together with ribavirin, for the treatment of Chronic Hepatitis C in adult patients without cirrhosis and in adult patients with compensated cirrhosis, including Hepatitis C Virus (HCV)/Human Immunodeficiency Virus (HIV) co-infection patients with stable HIV disease, with or without, antiretroviral therapy. Peginterferon alfa-2a is also indicated as a monotherapy for the treatment of both Hepatitis B Viral Early Antigen (HBeAg)-positive and HBeAg-negative chronic hepatitis B in patients with compensated liver disease, liver inflammation and evidence of viral replication.

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 Peginterferon Alfa-2a, just click the ADD TO CART button.

HBEL

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