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• Landmark UCL Study Confirms Long-Term Safety and Efficacy of Gene Therapy for ADA-SCID October 2025 · London, UK — A new study led by researchers at University College London (UCL) and Great Ormond Street Hospital has confirmed the long-term safety and efficacy of gene therapy for tre... More+
• Instructions for Use of Human Granzyme B ELISA Detection Kit
• Big News: Newly released “Good Manufacturing Practice for Cellular Therapy Products (Interim)”! On October 31, 2022, in order to guide the drug MAH to standardize the production and quality management of cell therapy products, the National Bureau Verification Center issued the "Guidelines f... More+
• Kelonia Therapeutics and Johnson & Johnson Form Strategic Collaboration to Develop Next-Generation In Vivo CAR-T Therapies October 2025 · Cambridge, Massachusetts — Kelonia Therapeutics announced today a strategic collaboration with Johnson & Johnson to advance the development of in vivo CAR-T cell therapies, a next... More+
• Products Hillgene delivers GMP-grade kits and reagents for plasmids, viruses, cells, and mRNA, enabling robust quality control and safe, scalable cell therapy development across preclinical to clinical stages. More+
• Instructions for Use of Human IFN-γ ELISA Detection Kit-IF001
• MAH issued“Provisions for Supervision and Administration of Drug Quality (Interim)” On November 29, the State Food and Drug Administration publicly solicited opinions on the "Regulations on the Supervision and Management of Drug Quality by Drug Marketing Authorization Holders&qu... More+
• FDA Introduces “Plausible Mechanism” Pathway to Accelerate Approval of Ultra-Rare and Personalized Gene Therapies November 2025 · Silver Spring, Maryland — The U.S. Food and Drug Administration (FDA) has announced a new “Plausible Mechanism” approval pathway to accelerate the review and authorization of ultra... More+
• Company Cell Therapy Innovation Inspired More+
• Instructions for Use of Human IFN-γ ELISA Detection Kit-IF002
• NMPA issued the Announcement on “Implementing Electronic Application of Drug Registration” In order to improve the efficiency of drug review and approval, the National Medical Products Administration has decided to implement electronic submission of drug registration application materials. ... More+
• FDA Issues Strongest Safety Warning for Sarepta’s Gene Therapy Elevidys After Two Fatal Liver Injury Cases The U.S. Food and Drug Administration (FDA) has added a boxed warning—its most serious level of safety alert—to Sarepta Therapeutics’ gene therapy Elevidys, following the deaths of two Duchenne mus... More+
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• Instructions for Use of Human Residual DNA Detection Kit (qPCR)
• Cellex Symposium 2025 Highlights the Next Phase of Cell and Gene Therapy Industry Development Frankfurt, Germany · November 2025 — On November 6, 2025, the Cellex Symposium 2025 was successfully held in Frankfurt, Germany, bringing together over 100 leading scientists, industry executives, r... More+