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• 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+
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• 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+
• Industry Insight | 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+
• Privacy Policy This website collects information from our users at several different points on our website in order to process reservations and better serve you with pertinent information. This website is the sole o... More+
• Instructions for Use of DNase I ELISA Detection Kit
• European Medicines Agency updates Reflection Paper on GMP Responsibilities of MAHs On July 27, the European Medicines Agency (EMA) released a reflection paper on GMP and MAH, "Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders", which stipu... More+
• Industry Insight | European Commission Grants Approval for Lentiviral Vector–Based CAR-T Therapy Hillgene, a global CDMO specializing in end-to-end viral vector and cell therapy manufacturing solutions, is committed to advancing next-generation therapies through high-quality, scalable platforms. ... More+
• CDMO Services for Lentiviral Vectors-IND Grade Lentivirus, a subtype of retrovirus, can integrate the target gene into the host cell genome, and is commonly used as a viral vector for ex vivo cell engineering. With the emergence of cellular therap... More+
• Instructions for Use of dsRNA ELISA Detection Kit
• The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs (Draft for Comments)” Chapter 1 ScopeArticle 1 [Scope] The cell therapy products (hereinafter referred to as cell products) described in this appendix refer to living cell products of human origin, including cells that hav... More+
• Industry Insight | Breakthrough in NK Cell Expansion: Novel K562 Feeder Line Enhances Yield and Purity A new study published in BMC Biotechnology introduces an innovative engineered K562 feeder cell line (K562-4-1BBL-mbIL-21/IL-15) that has demonstrated remarkable performance in NK cell expansion. Rese... More+
• Instructions for Use of E.coli HCP ELISA Detection Kit (2G)