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• Industry Insight | MIT Researchers Develop Tunable Gene Expression System for Synthetic Biology and Therapeutic Applications October 2025 — Cambridge, MA — A team of scientists at the Massachusetts Institute of Technology (MIT) has developed a new system that allows researchers to precisely dial up or down the expression ... More+
• Instructions for Use of HIV-1 p24 ELISA Detection Kit
• CDE: Notification of Public Comment Soliciting on “Technical Guideline for the Clinical Research and Development of New Drug Products for Chronic Lymphocytic Leukemia (Draft for Comments)” Chronic lymphocytic leukemia (CLL) is a mature B lymphocyte clonal proliferation tumor that mainly occurs in the middle-aged and elderly population. Its overall incidence rate is increasing due to the... More+
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• Industry Insight | UMass Chan Launches Global Gene and Cell Therapy Training Program to Advance HIV Cure Research October 2025 · Worcester, Massachusetts — UMass Chan Medical School announced a five-year partnership with Makerere University and Mbarara University of Science and Technology in Uganda to strengthe... More+
• Plasmids CDMO Solution More+
• Instructions for Use of Host Cell Residual DNA Sample Pretreatment Kit (Magnetic Bead Method)
• Big News: FDA issued the finalized version of guidance “Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA” Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (October 2022)On October 13, 2022, the FDA (CDER and CBER) issued the... More+
• Industry Insight | 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+
• Industry Insight | 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+
• 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+
• Industry Insight | 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+