CDMOs Cook, Patheon FDA-Approved To Manufacture Halozyme's Hylenex

Cook Pharmica and Patheon, contract development and manufacturing organizations (CDMOs), have received Food and Drug Administration (FDA) approval to manufacture Halozyme Therapeutics’ Hylenex recombinant (hyaluronidase human injection). Halozyme announced the approval in a press release, stating that Cook’s facility in Bloomington, Indiana will produce rHuPH20, the Hylenex active ingredient, and Patheon’s facility in Greenville, North Carolina will produce the finished Hylenex product.

Dr. Helen Torley, President and CEO of Halozyme, said, "The approval of new production sites enables us to substantially increase our manufacturing capacity for Hylenex recombinant.”

FDA-Approved Hylenex Manufacturing

Halozyme and its partner, Baxter, need additional supply because Baxter’s HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], an immunoglobulin treatment for adult patients with primary immunodeficiency (PI), was recently approved by the FDA and is ready for launch. The FDA follows its drug approvals by monitoring and approving the facilities that manufacture drugs and biologics. The federal agency looks for controls that ensure the product is safe for use including the ingredients and finished products.

The approvals at the Cook and Patheon facilities indicate that the FDA has inspected samples, the facility, equipment, and the skills of the site’s personnel. Dr. Torley states that the approvals signify that Halozyme has the capabilities to reliably manufacture Hylenex and sets the stage for manufacturing other products and for future partnerships for its rHuPH20 technology.

rHuPH20 and Hylenex

Hylenex was approved in 2005 as a tissue permeability modifier. It is administered by injection subcutaneously as a fluid for hydration, to increase the dispersion and absorption of other injected drugs, and in urography for improving resorption of radiopaque agents. Part of Halozyme’s ENHANZE technology, rHuPH20 is an enzyme that degrades hyaluronan temporarily, creating an opening in the subcutaneous space in the human skin so molecules as large as 200 nanometers can pass through.

About Halozyme, Cook, Patheon

Currently, Halozyme partners with Pfizer, Hoffman-LaRoche, and Baxter on the ENHANZE platform. Hoffman-La Roche and Halozyme are working on eight biological treatments, including Herceptin and Mabthera. Halozyme is seeking additional partners for its technology that can be used with biologics, drugs, and fluids. The company states that oncology, diabetes, and dermatology are targets of interest due to significant unmet medical needs.

Cook Pharmica provides mammalian cell culture, parenteral manufacturing in vials and prefilled syringes, and secondary packaging.

Patheon, a business unit of DPx Holdings B.V, provides manufacturing of solid and sterile dosage forms, including large and small molecule APIs.