OEL Fastrac Catalog

Hyaluronidase (human recombinant) (also known as rHuPH20 and vorhyaluronidase alfa) is a human recombinant form of the naturally occurring human enzyme hyaluronidase with potential chemoadjuvant activity. Hyaluronidase (human recombinant) is produced by genetically engineered Chinese hamster ovary (CHO) cells containing a deoxyribonucleic acid (DNA) plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase (human recombinant) (rHuPH20) is indicated for subcutaneous (SC) fluid administration for hydration and increasing resorption of radiopaque agents in SC urography. Hyaluronidase is also indicated by multiple routes to increase the dispersion and absorption of other injectable drugs. Hyaluronidase (human recombinant) (rHuPH20) was developed to lessen allergenicity and immunogenicity concerns associated with animal-derived hyaluronidases, enabling broader therapeutic applications for patients, including repeat dosing/chronic administration. Hyaluronidase (human recombinant) (rHuPH20) can be used to optimize SC administration of biologic therapies, facilitating faster administration of larger volumes that can reduce the number (and potential frequency) of individual injections required as well as increasing delivery flow rates compared with standard SC administration.

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 Hyaluronidase (Human Recombinant), just click the ADD TO CART button.

HBEL

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