Regulatory Guidelines

A number of guidelines describe the viral safety evaluation of biological products. The organizations that publish these guidelines include the following: FDA (Food and Drug Administration), EMEA (European Agency for the Evaluation of Medical Products), WHO (World Health Organization), EP (European Pharmacopea), and ICH (International Conference on Harmonization).

The major guidelines concerning virus validation are as follows:

  • Guidance on Virus Validation Studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses. Date for coming into operation: 14 August 1996. (CPMP/BWP/268/95) Version 2. February 1996.
  • Guidance on Quality of Biotechnological Products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. (CPMP/ICH/295/95) ICH Topic Q 5 A, Step 4, Consensus Guideline, 4 March 1997. Date for coming into operation: October 1997.
  • Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO Technical Report, Series N°924, 2004.
  • PTC: February 1997: Points to Consider in the manufacture and testing of monoclonal antibody products for human use.
  • Guidance on virus validation studies: The design, contribution and interpretation of studies validating the inactivation and removal of viruses EMEA/CHMP/BWP/398498/05: February 2009

The major guidelines concerning unwanted immunogenicity (ADA):

  • EMA, 2007 Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
  • FDA, 2009 Draft Guidance for industry Assay development for immunogenicity testing of therapeutic proteins
  • EMA, 2012 Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use EMA/CHMP/BMWP/86289/2010
  • FDA, 2013 Draft Guidance, Immunogenicity Assessment for Therapeutic Protein Products

The major guidelines concerning bioanalytical assay validation:

  • ICH Q2R1
  • FDA Guidance “Bioanalytical Method Validation” (rev1, 2013)
  • EMA guideline on validation of bioanalytical method EMA/CHMP/EWP/192217/2009 (2011)
  • Draft USP <1033>

Texcell will aid in communications with the regulatory authorities, as we have established relationships with regulatory agencies worldwide. Technical documents and study plans in full compliance with the regulatory guidelines can be provided. An expert report to document the biosafety of your product can be written to help support the robustness of your manufacturing process.

All information can be provided upon request.