USP [1132] RESIDUAL HOST CELL PROTEIN MEASUREMENT IN BIOPHARMACEUTICALS 宿主细胞蛋白残留检测.pdf

Printed on: Tue Dec 22 2020, 01:57:22 AM Official Status: Currently Official on 22-Dec-2020 DocId: 1_GUID-636A76B7-028E-4F4F-B1C2-4592B3EAF8D9_1_en-US (EST) Printed by: Jinjiang Yang Official Date: Official as of 01-Dec-2015 Document Type: GENERAL CHAPTER @2020 USPC 1 á1132ñ RESIDUAL HOST CELL PROTEIN MEASUREMENT IN BIOPHARMACEUTICALS 1. INTRODUCTION AND SCOPE Many medicinal products are produced through recombinant technology via a host cell (e.g., bacteria, yeast, or mammalian, insect, or plant cell lines). During the manufacture of such products, some amount of non-product, host cell-derived material will inevitably be introduced into the process stream. This process results in a mixture of the desired product and host cell-derived impurities, including host cell proteins (HCPs), and other process-related impurities that will be targeted for clearance through bioprocessing. Residual HCPs have the potential to affect product quality, safety, and efficacy; therefore, the quantity of HCPs should be low. The product purification processes must be optimized to consistently remove as many HCPs as feasible, with the goal of making the product as pure as possible. The primary concern with HCPs in biopharmaceutical products is their potential to induce anti-HCP antibodies that could induce a clinical effect in patients. In addition, HCPs may possibly act as adjuvants, which can induce anti-drug antibodies that can affect the safety or efficacy of the drug. A more extensive discussion of immunogenicity and its effect on preclinical and clinical stud