Publications

Keep up-to-date on the latest work from our in-house experts. We produce a wide range of publications from whitepapers, roadmaps, scientific posters and presentations. Contact us for more information on any of the topics below.

Developing an Early-Stage Target Product Profile (TPP)Selection of appropriate non-clinical models to ensure translatability of novel AAV-gene therapies to the clinicAdeno-associated virus production platform performance for 2L and 50L scalesATTC 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 UKPreparing for the future of advanced therapies:National Cell and Gene Therapy Vision for the UKCGT Catapult Guidance on the development and marketing of ATMPs in the UK and EU at this position post-BREXITHealthcare system readiness for the adoption of advanced therapies: learnings from the introduction of CAR T cell therapies in the UKProcess analysis of pluripotent stem cell differentiation to megakaryocytes to make platelets applying European GMPApprentice Supervisor and Mentor Training - September 2020Increasing patient access to advanced therapies; the UK perspectiveOptimising the design of clinical trials for advanced therapies workshop reportProcess Analytical Technology Strategy For Lentiviral ManufactureSafety of Cell Therapy Products In vitro Methods to Assess the Tumorigenicity of Human Cell-Based Therapeutic ProductsThe need for development of new analytical solutions for quality testing of ATMPs throughout manufactureSafety 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 operationATMP Project - Perspectives on preparedness: healthcare system readiness for adoption of disruptive innovative technologiesIncreasing 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 immunotherapyThe potential of cell and gene therapiesLogistics by design: a framework for advanced therapy developers to create optimal Logistics PlatformsATTCs, clinical infrastructure requirements and adoption of ATMPs workshopApprenticeships in advance therapies - managers checklistApprenticeships in advance therapies - guidance bookletA 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 USThe 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 EuropeAddressing the challenges of expansion of hPSCsT-cell therapy bioprocessingRaman spectroscopy as a process analytical technologyAnticipating the clinical adoption of regenerative medicineCell and Gene Therapy Catapult manufacturing centreCGT Catapult House of Lords inquiry responseAnnuity 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 AccessScreening of defined medium for the adherent expansion of an induced pluripotent stem cell lineDevelopment 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 PSCsDevelopment of a cost efficient platform for the industrial manufacturing of pluripotent stem cell derived products for cell therapyImproving Expansion of Pluripotent Stem Cells in Stirred Tank ReactorsComparability: manufacturing, characterization and controlsEvaluation 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 USRoadmap to market access for England and WalesRoadmap to market access for SpainRoadmap to market access for ItalyRoadmap to market access for FranceRoadmap to market access for GermanyRegenerative Medicines Expert Group report 2016Cell History File TemplateThe European healthcare market: Reimbursement of licensed cell and gene therapiesVariations in cell therapy reimbursement across the Big5EUUK Market Access Considerations for the Cell Therapy IndustryDendritic Cell TherapiesEarly Access to Medicines SchemePreclinical services and clinical biomarker industry survey reportGenetically Modified T Cell Therapies for Cancer - Basic FactsInnovator cell therapies present barriers to the entry of copy versions regardless of patent protection