Resources and tools
Scroll through a selection of resources, including our industry-leading clinical trials database and manufacturing survey.
We publish a range of content providing detailed analysis and expert commentary on all aspects of the cell and gene therapy sector in the UK. Here you can find a selection of resources, including our industry-leading clinical trials database and manufacturing survey.
Artificial Intelligence, Machine Learning, and Digitalisation Systems in the Cell and Gene Therapy Sector: A Guidance Document from the ISCT Industry CommitteesThe manufacture of AAV for gene therapy applications using a closed, semi-automated hollow-fiber bioreactorAccelerating delivery of life-changing ATMPs through collaboration & innovation in the UKBridging academia and industry in cell and gene therapies: A fireside chat with Dan Gibson and Qasim RafiqReview of UK competitive advantage from a regulatory and market access perspectiveFrom bench to boardroom: What investors seek in emerging biotechs?Multi-omics data integration to improve AAV manufacturingState of the UK cell and gene therapy industry in 2021UK GMO CU Authorisation Procedures for Clinical Trial Products January 2025Clinical Trials Database 2024Building the digital infrastructure for capturing patient outcomes data from routine clinical practice: The AIM4ALL initiative in ScotlandGMP Manufacturing Report 2024ATMP clinical trials in the UKSpinning Out: The path from academic research to launching a successful new companyTPP generation for early-stage development of advanced therapies and vaccines: Open competition for Scottish academicsScalable GMP Viral Vector Manufacturing: A Digitised Platform Ready for CollaborationLeveraging mass photometry for efficient, precise, and rapid adeno-associated virus (AAV) empty:full quantificationUtilising the Innovative Licensing and Access Pathway (ILAP) to support adoption of advanced therapiesOvercoming challenges in the industrialisation of iPSC-derived therapiesDeveloping a robust target product profile (TPP) for successful therapy adoptionEvaluation of the Patient Referral Pathways for Gene Therapy and CAR-T in the UKClinical Trials Database 2023 - HighlightsClinical Trials Database 2023Developing an Early-Stage Target Product Profile (TPP)UK Cell and Gene Therapy Skills Demand Report 2023GMP Manufacturing Report 2023Advanced Flow Cytometry for Cell Therapy ManufacturingATMP Engage: Ensuring patients are at the heart of ATMP research and deliveryNavigating the pathway to first in human – A case study of a novel cell therapyImproving Adeno-Associated Virus (AAV) vector manufacturing through process development in GMP-ready cell linesSelection of appropriate non-clinical models to ensure translatability of novel AAV-gene therapies to the clinicDevelopment of an end-to-end closed iPSC expansion process using a cell specific perfusion regime for process intensificationClinical Trials: Regulatory Key Considerations & Clinical Operations (FIH Pathway scenario)Webinar - Process Analytical Technologies for Process Control StrategyATMPs: Examining the potential inequity of accessBuilding a common digital approach to unleash the CGT sector – Thoughts from cross-industry stakeholdersCell and Gene Therapy Catapult gender pay report 2021/22Cell and Gene Therapy Catapult gender pay report 2022/23Adeno-associated virus production platform performance for 2L and 50L scalesOverview of current GMO regulatory landscapeClinical Trials Report 2022Clinical Trials Database 2022ATTC Bridging CAR T Patient Referrals Executive SummaryHealthcare system readiness for the adoption of advanced therapies: learnings from the introduction of CAR T cell therapies in the UKGMP Manufacturing Report 2022CGT Catapult Regulatory Round up September 2022CGT Catapult Regulatory Round up August 2022Justifying long term durability of gene therapies using analogue dataClinical Trials Database 2021 commentaryClinical Trials Database 2021CGT Catapult Guidance on the development and marketing of ATMPs in the UK and EU at this position post-BREXITWEBINAR: State of the UK cell and gene therapy industry in 2021GMP manufacturing report 2021UK Cell and Gene Therapy Skills Demand Report 2021Process analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMPThe role of big data analytics in digitised manufacturingThe art of upscalingThe UK ATMP Landscape 2021The use of innovative payment mechanisms for gene therapies in Europe and the USAAnnual Review 2020Clinical Trials Database 2020 commentaryClinical Trials Database 2020CGT Catapult Clinical Adoption Day 2020 ReportGMP manufacturing report 2020The implementation of outcomes-based reimbursement for gene therapies, using the recent launch of CAR-T cell therapies as an example.A new approach to cell therapy classification and an assessment of clinical translational challengesIncreasing Patient Access to Advanced Therapies: the UK PerspectiveAdvanced therapy regulation in the UK: what might the future hold post-Brexit?UK and EU Regulatory Affairs Support at CGT CatapultBarriers and opportunities: The clinical adoption of advanced therapiesThe necessity of automated manufacture for cell-based immunotherapies: a cost-based analysisOptimising the design of clinical trials for advanced therapies workshop reportCell and Gene Therapies & Their GMP RequirementsProcess Analytical Technology Strategy For Lentiviral ManufactureClinical Trials Database 2019 commentaryClinical Trials Database 2019The need for development of new analytical solutions for quality testing of ATMPs throughout manufactureGMP manufacturing report 2019UK cell and gene therapy skills demand report 2019Safety of Cell Therapy Products: In vitro Methods to Assess the Tumorigenicity of Human Cell Based Therapeutic ProductsDevelopment of a scalable platform for AAV manufacturingSingle cell analysis of lentiviral integration to support ex-vivo gene modified cell therapy developmentCell and Gene Therapy Catapult manufacturing centre - one year in operationAnnual Review 2019Enabling outcomes-based reimbursement in oncology in England by upgrading the SACT dataset and EBMT registry.Determining opportunities and challenges for launching cell and gene therapies by assessing the patient outcomes data collection infrastructure in the UKThe Cell and Gene Therapy Catapult approach to pricing and reimbursement strategy developmentIncreasing lentiviral transduction efficiencyAutomated analysis of morphology attributes of PSCs in adherent and suspension cultureDevelopment of iPSC processing platformsDevelopment of an analytical strategy to ensure production efficiently and consistency of a WT1-TCR immunotherapyTransfer into GMP and CGT Catapult iPSC line - BHF WorkshopThe next generation of AAV analyticsT-Cell Therapies - Building an ecosystem to maximise successiPSC vs ESC challenges and considerations - BHF WorkshophPSC expansion and differentiation methods - BHF WorkshopApplying Quality by Design to Cell and Gene TherapiesAAV next generation quality controlWebinar: Viral vectors - what are the solutions to current scale up challengesViral vectors - what are the solutions to current scale up challengesThe potential of cell and gene therapiesAnnual review 2018Clinical Trials Database 2018 commentaryClinical Trials Database 2018Logistics by design: a framework for advanced therapy developers to create optimal Logistics PlatformsGMP manufacturing report 2018BIA webinar: Adaptive manufacturingATTCs, clinical infrastructure requirements and adoption of ATMPs workshopApprenticeships in advance therapies - managers checklistApprenticeships in advance therapies - guidance bookletPreclinical Development of Cell-Based Products: a European Regulatory Science PerspectiveScalable Cell-Based Immunotherapy Manufacture: A Comparison of Single-Use Agitated and Static Expansion TechnologiesA hypothetical CAR-T therapy: determining the expenses involved in setting up managed entry agreement based on performancePotential price and access implications of the cost-utility and budget impact methodologies applied by NICE in England and ICER in the USRaman spectroscopy as a process analytical technology for cell therapy bioprocessingThe potential effects on pricing and accessibility of a new gene therapy for Parkinson's diseases, using the cost-effectiveness and budget impact methodologies utilised by NICE and ICERProposed Solutions to Further Improve the Regulatory Landscape for ATMPS in EuropeThe challenges of ATMP development and supplyAddressing the challenges of expansion of hPSCsT-cell therapy bioprocessingRaman spectroscopy as a process analytical technologyOptimisation of indication selection and prioritisationT-cell Immunotherapies and the Role of Nonclinical AssessmentAnticipating the clinical adoption of regenerative medicineThe Importance of Understanding & Designing Cellular Therapy Supply ChainsWhy is Adaptive Manufacturing of Biologics Difficult?Stem Cells. In: McQueen, C. A., Comprehensive Toxicology, Third EditionAnnual Review 2017Importance of Innovation and Design in the Scalability of Cell & Gene TherapiesClinical Trials Database 2017 commentaryClinical Trials Database 2017GMP manufacturing report 2017Clinical Trials Database 2016Clinical Trials Database 2015Clinical Trials Database 2016 commentaryClinical Trials Database 2014Clinical Trials Database 2015 commentaryClinical Trials Database 2014 commentaryClinical Trials Database 2013 commentaryClinical Trials Database 2013Clinical Trials Database 2012Clinical Trials Database 2012 commentaryCell and Gene Therapy Catapult manufacturing centreOpportunities and challenges with performance based pricing schemes for ATMPsPreclinical development of an automated injection deviceAnnuity payments outlined in England’s net budget impact test may increase patient access to innovative cell and gene therapiesAnnuity payments can increase patient access to innovative cell and gene therapiesExpansion of human pluripotent stem cells in stirred tank reactorsDevelopment of a cell therapy PAT strategy based on multiparametric product characterisationSingle cell analysis of viral copy numberThe High Cost of High Tech Medicine: Planning Ahead for Market AccessOptimising facility layoutsScreening of defined medium for the adherent expansion of an induced pluripotent stem cell lineChallenges of building a new organisation in cell and gene therapyDevelopment of a novel potency assayDevelopment of processing platforms for industrial manufactureCFD simulation of small-scale single-use stirred tank bioreactorsCharacterisation of a dynamic modular automated systemA strategy for robust implementation of process analytical technologiesTransfer and optimisation of ATMP manufacturingClosed expansion and harvest of pluripotent stem cellsDeveloping integrated platform processing optionsDevelopment of an identity assay for in process and release testingDynamic array based method for high throughput and flexible assessment of pluripotency in PSCsTranslational Regenerative Medicine, Cell Therapy LandscapeCommercialisation of CAR T-cell therapies: business model spectrumCell and gene therapy manufacturing: the necessity for a cost-based development approachCell & gene therapies and the evolving role of personalized medicineDevelopment of a cost efficient platform for the industrial manufacturing of pluripotent stem cell derived products for cell therapyRequirement for smart in-process control systems to deliver cell therapy processes fit for the 21st centuryImproving Expansion of Pluripotent Stem Cells in Stirred Tank ReactorsManufacturing process development of ATMPsCAR T-cell therapies: formulation-product-proposition framework for commercialisationCell and gene therapies - the emerging fourth pillar of healthcare systemsFootprint-Free Human Induced Pluripotent Stem CellsRegenerative Medicine: From Protocol to PatientComparability: manufacturing, characterization and controlsCustomer pyramid framework for CAR T-cell therapies in immuno-oncologyManufacturing facility for current and future multi-product processesEvaluation of a novel bench-top stirred-tank bioreactor for process development of autologous T-cell therapiesThe Impact of Thaw Rate on the Recovery and Proliferation of MSCs and T cellsComparing pricing of recently launched pharmaceuticals in the UK and the USMesenchymal Stromal Cells, 1st EditionLandscape of current and emerging cell therapy clinical trials in the UK: current status, comparison to global trends and future perspectives.Cells: from Robert Hooke to cell therapy – a 350 year journeyCell-based therapy technology classifications and translational challengesThe next stage in regulation and reimbursement: Bringing regenerative medicines to the clinicCell History File TemplateCells: from Robert Hooke to cell therapyThe European healthcare market: Reimbursement of licensed cell and gene therapiesGuide to Cell Therapy GxP: Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical EnvironmentsSetting Up a Haplobank: Issues and SolutionsMarket Access Pathways for Cell Therapies in FranceThe issue of immunology in stem cell therapies: a pharmaceutical perspectiveGenetically modified T cells in cancer therapy: opportunities and challengesEarly Access to Medicines SchemeGenetically Modified T Cell Therapies for Cancer - Basic FactsTreatments for managing the complications of ischemic central and retinal vein occlusions: A systematic literature reviewGMP manufacturing report 2016The management of beta thalassemia in the United Kingdom: Healthcare costs and outcomes over a 50 year periodGMP manufacturing report 2015GMP manufacturing report 2014