Regulatory guidelines

Over the years, regulatory agencies world-wide have issued various guidelines and point-to-consider for biological identity and safety tests. To assist our clients to better understand regulatory requirements, we have compiled a series of documents from US FDA, ICH, and WHO.

Cell Bank Characterization

  • FDA_1984_PTC_Cell_Line_Characterization TITLE: Points to consider in the characterization of cell lines used to produce biological products
  • FDA_1993_PTC_Cell_Line_Characterization TITLE: Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993)
  • WHO_2010_Cell_Line_Characterization TITLE: Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks
  • Gene therapy

  • EMEA_2009_Gene_Therapy TITLE: Questions and Answers on Gene Therapy
  • FDA_1998_GFI_Somcell TITLE: Guidance for Human Somatic Cell Therapy and Gene Therapy
  • FDA_2008_GFI_Somcell TITLE: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
  • in vivo diagnostic device

  • FDA_1989_PTC_HIV TITLE: Draft of “Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus, Type 1 (1989)”
  • FDA_1999_GFI_HIV TITLE: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2
  • FDA_2011_GFI_Influenza TITLE: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses
  • mAb antibody

  • FDA_1997_PTC_mAb TITLE: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
  • Pharmacogenetic and genetic tests

  • FDA_2005_GFI_Genotyping TITLE: Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System
  • FDA_2005_GFI_Mutation_Device TITLE: Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems
  • FDA_2007_GFI_Tests TITLE: Pharmacogenetic Tests and Genetic Tests for Heritable Markers
  • Recombinant DNA

  • FDA_1983_PTC_rDNA TITLE: Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technolog
  • FDA_1985_PTC_rDNA TITLE: Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology
  • FDA_1992_PTC_rDNA TITLE: Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologic& Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability
  • FDA_1996_GFI_rDNA_mAb TITLE: FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE
  • ICH_1996_Q5B_rDNA TITLE: ICHTopic Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cell Lines Used for Production of r-DNA Derived Protein Products
  • Vaccine

  • FDA_2007_GFI_Plasmid_DNA_Vaccine TITLE: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications
  • <a href="http://avancebio.com/wp-content/uploads/Regulations
  • /FDA_2010_GFI_Viral_Vaccine.pdf”>FDA_2010_GFI_Viral_Vaccine TITLE: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications

    Viral safety

  • EMEA_2006_Viral_Safety TITLE: GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS
  • ICH_1997_Viral_Safety TITLE: VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN
  • ICH_1998_Q5A_Viral_Safety TITLE: Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin