FDA approves more manufacturing facilities for Halozyme’s Hylenex recombinant production

The approval allows the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville for production of finished Hylenex product.

Halozyme president and chief executive officer Helen Torley said the approval of new production sites enables the company to substantially increase its manufacturing capacity for Hylenex recombinant.

"Furthermore, the approvals demonstrate our capabilities in the manufacturing and operations area to ensure continuous supply of active ingredients and finished commercial drug products which are essential for our core strategy to commercialize our own proprietary products as well as partner our rHuPH20 technology with innovative companies," Torley said.

Hylenex recombinant is a tissue permeability modifier indicated as an adjuvant to increase the dispersion and absorption of other injected or subcutaneously infused drugs, to facilitate subcutaneous fluid administration and in subcutaneous urography.

Local injection site reactions, such as erythema and pain are the most frequently reported adverse reactions with Hylenex recombinant.