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Cell and gene therapy (CGT) had developed rapidly since 2017 when two CAR-T cell therapy drugs were approved by FDA. However, quality research and quality control are more complicated due to the large heterogeneity in the cell source, type, and in vitro operation of cell and gene therapy products. FDA and EMA issued a series of guidelines to standardize the research and development of CGT products and improve their safety, effectiveness, and quality control ability.
FDA\EMA CGT Drug Regulation
| Publishers | File name |
|---|---|
| FDA | Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) |
| FDA | Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up |
| FDA | Long Term Follow-Up After Administration of Human Gene Therapy Products |
| FDA | Human Gene Therapy for Retinal Disorders |
| FDA | Human Gene Therapy for Rare Diseases |
| FDA | Human Gene Therapy for Hemophilia |
| FDA | Recommendations for Microbial Vectors used for Gene Therapy |
| FDA | Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products |
| FDA | Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products |
| FDA | Preclinical Assessment of Investigational Cellular and Gene Therapy Products |
| FDA | Potency Tests for Cellular and Gene Therapy Products |
| EMA | Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials |
| EMA | Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products |
ACROBiosystems support your CGT drug approval
• Site-specific conjugation
• High bioactivity verified by FACS
• Minimal non-specific background
• Ideal for CAR detection in quality control
• High sensitivity and specificity
• Suitable for CD19 CAR detection in clinical trials
• APC\PE\FITC\Biotin-labeled forms available
• FDA DMF filed to support your IND or BLA
• 16 quality control standards
• Raw materials and packing materials are registered
• A comprehensive set of regulatory documents is available
• Free sample offered
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