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.
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
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
When you partner with Avance Biosciences™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
Dedication to Quality
The Avance Biosciences™ team is committed to strict adherence to CGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.
Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.
Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.
Avance Biosciences™’ CGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.