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• Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Gene Therapy Products (Draft for Comments)” Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Products(Draft for Comments)ForewordIn recent years, with the continuous advancement of gene delivery systems and editin... More+
• LVV CDMO Features More+
• Instructions for Use of CHO HCP ELISA Detection Kit
• Academician Zhang Dan of Hillgene Was Invited to Attend and Make His Presentation at the 22nd Taihu Economic and Trade Cooperation Meeting of Wuzhong District On November 1, the 2022 Suzhou Wuzhong (22nd) Taihu Economic and Trade Cooperation Fair was held on the banks of the beautiful Taihu Lake. Academician Zhang Dan, foreign academician of the Russian Aca... More+
• [IIT] Announcement on Public Comment Soliciting on the “Administrative Measures for Investigator Initiated Clinical Trials by Medical and Health Institutions (Draft for Comments)” Measures for the Administration of Clinical Research Initiated by Medical and Health Institutions(Draft for Comments)Chapter I General ProvisionsArticle 1 (Purpose) In order to standardize the managem... More+
• Hillgene Lentiviral Vector CDMO Features Manufacturing of plasmids, a critical step of manufacturing CAR-T cellular therapy products, involves a series of complicated processes of manufacturing, purification, and analysis. As essential tools... More+
• Lentivirus Vector RNA Copy Number Detection Kit This kit utilizes fluorescently labeled specific probes or dyes that bind to specific sequences in lentiviral nucleic acids. During PCR amplification, real-time monitoring of DNA amplification is achi... More+
• Instructions for Use of CHO Residual DNA Detection Kit (qPCR)
• Hillgene Was Awarded the Most Promising and Innovative CXO Company of the Top Value Innovative Companies in the Biomedical Science and Technology Industry of China in 2022 On November 10, the 24th Shanghai International Biotechnology and Pharmaceutical Symposium (BIO-FORUM) Series | China Biotechnology and Pharmaceutical Innovation Forum and the 2022 China Biomedical Sc... More+
• Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Trial of Cell-based Immunotherapy Products (Interim)” (No. 14, 2021) In 2017, the former State Food and Drug Administration issued the "Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)", which generally elaborated on the techn... More+
• IND Grade More+
• Instructions for Use of CRS Cytokine Multiplex ELISA Detection Kit
• NMPA issued the “Measures for the Administration of Drug Inspection (Interim)”, and abolished the original drug administrative measures for GMP and GSP certification! Chapter I General ProvisionsArticle 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of the People&#... More+
• Residual K562 feeder cell Detection Kit This kit utilizes RT-PCR with specifically designed target sites for the detection of residual K562 feeder cells. K562 cells engineered via gene editing are widely studied and utilized for their excel... More+
• FDA Removes REMS Requirements for CAR-T Therapies, Paving the Way for Broader Patient Access The U.S. Food and Drug Administration (FDA) has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for currently approved BCMA- and CD19-directed CAR-T therapies, the agency ann... More+