Human Tissue Authority

The regulator for human tissue and organs

Position on the procurement of tumour material

Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP).

Certain types of immunotherapies require the use of tumour material in their manufacture. Where the tumour material will comprise part of the active substance of the final product, it will be considered to be starting material for the manufacture of an ATMP; Directive 2004/23/EC will apply for donation, procurement and testing. In the UK these activities are regulated by the HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations).

The following scenarios have been developed to set out the HTA licensing requirements for these types of materials. They are intended to act as guidance for those seeking assurance about how to demonstrate that tumour material procured for use in the manufacture of an Advanced Therapy Medicinal Product (ATMP) meets UK requirements with respect to donation, procurement and testing. Any establishment seeking to conduct this type of activity should contact the HTA for further advice.

Scenario 1: The primary purpose of removing the tumour material is to obtain starting material for ATMP manufacture.

An HTA human application licence will be required for procurement and testing.

If the sample is to be stored, or processed, prior to transfer to an ATMP manufacturer, then these activities will also need to be licensed by the HTA.

Scenario 2: A tumour biopsy is being obtained for diagnostic purposes, or the patient is undergoing surgery for removal of the tumour. At the time of the procedure, it has been identified that the tumour material could be used for the purposes of ATMP manufacture, and a portion of the material is retained for these purposes.

Certain parts of the procurement procedure may not be subject to HTA licensing requirements. This could depend on a number of factors including: the procedure being undertaken to obtain the tumour; and whether the material is transferred directly to an ATMP manufacturer or is held at a tissue bank. In these circumstances, those undertaking the activity should contact the HTA for advice.

Regardless of licensing arrangements, all aspects of the procurement must meet the quality and safety standards required by the Q&S Regulations as set out in the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment. As a minimum, consideration must be given to: consent; traceability; SAEARS reporting; and packaging and transport.

Donor testing must occur at the time of procurement and this must be performed under the authority of an HTA licence.

If the sample is to be stored, or processed, prior to moving to an ATMP manufacturer, then these activities will also need to be licensed by the HTA. In these circumstances, once the material has been removed, it should be transferred to an establishment with an HTA human application licence under the supervision of a Designated Individual.

Scenario 3: A tumour biopsy was previously obtained for diagnostic purposes, or the patient underwent surgery for removal of the tumour and the material was retained. At the time of the patient undergoing the procedure, it had not been anticipated that the material would be used as a starting material for ATMP manufacture and the material was not procured, tested or stored in accordance with the Q&S Regulations.

The patient is subsequently identified as being suitable for inclusion in a trial for an ATMP and a portion of the retained material will need to be used for the manufacture of this therapy.

Where the primary purpose of removing the tumour is not the development of the ATMP and where the material has been removed prior to determining it will be used for these purposes, this could mean that it is not possible to work within the framework of the Q&S Regulations. Where this is the case, a risk assessment will need to be performed to determine the suitability of the tissue for its intended use. This should be conducted by a Designated Individual at an HTA licensed establishment. Once it has been identified that the tumour material will be used for clinical treatment, it should be stored and released in accordance with the Q&S Regulations under an HTA human application licence.

Depending on the outcome of the risk assessment, the HTA may require certain conditions for storage, labelling and release to be applied.

Scenario 4: An establishment wishes to import tumour samples into the UK for use as a potential starting material for the manufacture of an ATMP.

The Designated Individual of the importing establishment will need to ensure that imported samples meet the standards of quality and safety required by the Q&S Regulations for procurement and testing.

If the sample is to be stored in the UK prior to moving to an ATMP manufacturer, then this activity will also need to be licensed by the HTA.

From 1 April 2018, the requirements of import Directive (EU) 2015/566 will apply.

Scenario 5: An establishment wishes to import tumour samples into the UK to be retained for use as a potential starting material. These samples were originally obtained as pathology samples and have not been procured, stored, or tested in accordance with the Q&S Regulations.

The Designated Individual will need to perform a risk assessment and gap analysis to evaluate compliance with the Q&S Regulations and suitability of the tissue for its intended use. Depending on the outcome of the risk assessment, the HTA may require certain conditions for storage, labelling and release to be applied, once the material has been imported.

From 1 April 2018, the requirements of import Directive (EU) 2015/566 will apply.

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Last updated on: 29 Mar 2018