Considerations of pharmaceutical review of therapeutic recombinant protein drugs for subcutaneous injection
SAI Wen-bo
XU Long-chang
Abstract：In order to enhance patient compliance,subcutaneous injection(SI)is one of the important directions for differentiated development of therapeutic recombinant protein drugs(TRPDs).This has resulted in a significant rise in clinical trial applications and license applications of biologics in recent years.As for SI products,there are some special considerations in the development of formulation,excipient quality control,product quality control and stability studies compared with those of intravenous administration dosage forms,which are due to the inherent properties of TRPDs and the potential impact of high concentration formulation on product quality and stability,as well as the application of special excipients,represented by hyaluronidase.This manuscript presents a summary of the application of TRPDs in SI dosage form since 2020,discusses the special considerations in the review of chemical manufacturing and control(CMC),and the possible challenges that arise in the R&D and manufacturing process of this type of products.The objective is to offer patients new TRPD products that are safe,effective,quality-controlled,and user-friendly through the collaborative efforts of sponsors and the regulatory authority by strengthening technical communication.
Keywords：subcutaneous injectiontherapeutic recombinant protein drugformulationhyaluronidase
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2463-2466 )