TSJCI Annual Report 2021

Trinity St James’s Cancer Institute Annual Report 2021 14 Section 1.6 Histopathology, Cytology, Cancer Molecular Diagnostics, Immunology 1.6.1 Key Developments during 2021 Cancer Molecular Diagnostics (CMD) Department • In 2021 the CMD department continued to increase laboratory throughput to match the growing needs of the haematology and oncology services. • The service expanded to introduce a gene panel for the diagnosis and management of myeloid malignancy. • Changing patterns in diagnostics were also a feature of 2021 as cancer management continues to evolve and become increasingly defined by molecular diagnostics. Cryobiology Department • In 2021, the Cryobiology Laboratory Stem Cell facility, as part of the National Adult CAR-T programme, received authorisation for the collection and cryopreservation of stem cells for manufacture and the acceptance, storage and infusion of the genetically modified CAR-T product (Kymriah) from Novartis. • A change to the HPRA authorisation was completed and Irish Aviation Authority (IAA) authorised Known Consignor procedures were put into effect, for CAR-T starting product shipment. • The first CAR-T patient in Ireland had cells collected, processed by the laboratory in November and had the first CAR-T product received, stored and infused in December 2021. • Three patients had cells for CAR-T manufacture processed in 2021 and a full validation of the CAR-T process was undertaken. • A new Cellular Therapy Research group was established (chaired by Nicola Gardiner) in 2021 comprising of SJH Medical scientists and clinicians, with IBTS staff and Trinity College (TTMI) scientists to develop a common interest group in establishing research projects. • A PhD research project, seed funded by an IBTS research agreement, based on detailed laboratory monitoring of patients in the early post stem cell transplant and post CAR-T treatment was approved by the SJH Tallaght Research Ethics committee and a medical scientist enrolled with TCD. • A concurrent MD project has been established and combined Bio banking of consenting patient samples started in 2021 and is ongoing. • A research agreement was signed with Avectas a commercial company, who funded a preliminary study on CAR-T manufacturing and a final year medical scientist student and an MSc project was performed.