Advanced Therapy Medicinal Products Guidance – Application of Flow Cytometry

Confidence at every stage 

With the complexity and risk associated with each stage of assay development, the Advanced Therapy Medicinal Products (ATMP) Flow Cytometry best practice guidance offers a practical and phase appropriate validation tool to help your cell therapy programme succeed.

Approved and developed by the British Pharmacopoeia (BP), as part of the Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with experts from the cell and gene therapy community including industry, NHS and academia, the guidance is:

  • reliable phase appropriate support to every stage of assay development
  • a practical translation of regulation to support both new and experienced users
  • supportive of the development of robust internal procedures, data acquisition and documentation
  • flexible and adaptable, allowing the user to apply the guidance to their environment
  • harmonised with and links to existing industry guidance for an understanding of regulatory expectations

Available as part of the BP online, the new ATMP Flow Cytometry guidance provides a set of trusted guidelines to support the ATMP community to standardise operations and feel confident to do their job more efficiently.

 

Buy the BP online (single user )

Enquire about multi-user online access: pharmahealth@tso.co.uk