Advanced Therapy Medicinal Products Guidance

Confidence at every stage

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

  • Application of Flow Cytometry
  • Vector Copy Number
  • Characterisation of the Capsid Particle Population for rAAV products
  • T Cell and NK Cell Characterisation Assays

Developed and approved by the British Pharmacopoeia (BP), as part of the MHRA, in partnership with experts from the cell and gene therapy community including industry, NHS and academia, this guidance offers:

  • reliable, phase appropriate support to every stage of assay development
  • practical translation of regulation to support both new and experienced users
  • enables the development of robust internal procedures for data acquisition and documentation
  • flexible in how the user applies the guidance to their own environment
  • harmonisation with – and links to – existing industry guidance for an understanding of regulatory expectations

Available as part of the BP online and free to download, our new ATMP guidance supports the ATMP community to standardise operations and feel confident to do their job more efficiently.

Download the latest ATMP guidance now

We would like to thank all the experts who directly contributed to the creation of this guidance.

The British Pharmacopoeia Commission is currently looking to appoint new professional members for two new task groups focussing on providing non-mandatory best practice guidance on the topics of “Encapsidated DNA characterisation” and “Primary protein sequence modifications of encapsidated DNA.