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• EU Issues First-Ever GMP Annex on Artificial Intelligence: 10 Key Compliance Requirements for Pharmaceutical AI Brussels, July 7, 2025 — The European Commission and PIC/S (Pharmaceutical Inspection Co-operation Scheme) have jointly released the draft “GMP Annex 22: Artificial Intelligence (AI)”, launching a ... More+
• Instructions for Use of Gentamicin Residual ELISA Detection Kit
• Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Ex-vivo Genetic Modification System (Interim)” (No. 29, 2022) In order to standardize and guide the pharmaceutical research of in vitro gene modification systems, under the deployment of the National Drug Administration, the Drug Evaluation Center organized the ... More+
• CDMO Services for Lentiviral Vectors-Commercial 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+
• FDA Adds Boxed Warning to Johnson & Johnson and Legend Biotech’s CAR-T Therapy Carvykti October 10, 2025 — Washington, D.C. — The U.S. Food and Drug Administration (FDA) has issued a new safety update for Carvykti (ciltacabtagene autoleucel), a CAR-T cell therapy co-developed by Johnso... More+
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• Instructions for Use of HEK293 cell Residual DNA Detection Kit (qPCR)
• Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Interim)” (No. 30, 2022) In order to standardize and guide the pharmaceutical research and development, production and registration of immune cell therapy products, under the deployment of the National Medical Products Admini... More+
• Experimental Gene Therapy Restores Immune Systems in Children with Deadly Disorder An international research collaboration between UCLA, University College London (UCL), and Great Ormond Street Hospital has achieved a breakthrough in treating a fatal childhood immune disorder, adeno... More+
• Instructions for Use of HEK293 Cell Residual DNA Fragment Analysis Detection Kit (qPCR)
• Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of In-vivo Gene Therapy Products (Interim)” (No. 31, 2022) In order to standardize and guide the pharmaceutical research and development, production and registration of in vivo gene therapy products, under the deployment of the National Medical Products Admin... More+
• McKesson Report: Cell and Gene Therapies Grow Rapidly, but Cost and Access Gaps Persist October 2025 · Irving, Texas — McKesson Corporation, one of the world’s leading healthcare service and distribution companies, has released its latest industry report showing that while cell and ge... More+
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• Instructions for Use of Hela Cell Residual DNA Detection Kit (qPCR)
• CDE issued “Guidelines on Clinical Trial Statistics of Drug Products for Rare Diseases (Interim)” In order to encourage the development of drugs for rare diseases and guide applicants to improve R&D efficiency from the perspective of clinical research methodology, the Drug Evaluation Center or... More+