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Your Position: Home > Insights > Regulatory Requirements of Cell and Gene Therapy
Regulatory Requirements of Cell and Gene Therapy
Release time: 2022-04-25 Source: ACROBiosystems Read: 359

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

PublishersFile name
FDAChemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
FDATesting of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up
FDALong Term Follow-Up After Administration of Human Gene Therapy Products
FDAHuman Gene Therapy for Retinal Disorders
FDAHuman Gene Therapy for Rare Diseases 
FDAHuman Gene Therapy for Hemophilia
FDARecommendations for Microbial Vectors used for Gene Therapy
FDADesign and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products
FDAConsiderations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
FDAPreclinical Assessment of Investigational Cellular and Gene Therapy Products
FDAPotency Tests for Cellular and Gene Therapy Products
EMAGuideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials
EMAGuidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

ACROBiosystems support your CGT drug approval

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

ACROBiosystems support your CGT drug approval

• High sensitivity and specificity

• Suitable for CD19 CAR detection in clinical trails

• APC\PE\FITC\Biotin-labeled forms available

• FDA DMF filed to support your IND or BLA

ACROBiosystems support your CGT drug approval

•  16 quality control standards

•  Raw materials and packing materials are registered

•  A comprehensive set of regulatory documents is available

•  Free sample offered

Discovery Solutions for Cell and Gene Therapy

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