Kevin Bruce

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gap analysis tissue procurement process development optimisation scaleup gmp manufacture cell banking inprocess & final product qc testing qp batch certification gmp storage controlled temperature distribution to clinical sites worldwide biotechnology research cell therapy gene therapy cdmo ipsc cgmp master cell banks working cell banks analytical development manufacturing science clinical manufacturing commercial manufacturing regulatory compliance quality assurance supply chain management cryopreservation aseptic processing innovative technology biotechnology pharmaceutical manufacturing stem cell development translational medicine regenerative medicine quality control clinical trials product characterization customized solutions patient-centric allogeneic therapies autologous therapies gene editing crispr technology viral vector production biomanufacturing process validation drug product stability quality management systems advanced therapies therapy development health innovation clinical translation data management solutions advanced cell types patient safety manufacturing efficiency technology transfer histocompatibility diversity in biotech advanced cell therapies gene therapies contract development & manufacturing organization clinical-grade stem cells induced pluripotent stem cells ipsc development crispr gene editing cgmp manufacturing pharmaceutical partnerships global manufacturing innovative treatments life-changing therapies patient-specific solutions serious diseases therapeutic products clinical to commercial scale advanced biotechnology edinburgh hopkinton international market healthcare innovation transformative treatments patient empowerment scalable manufacturing cutting-edge technology logistics & supply chain pharmaceuticals medical health care health wellness & fitness hospital & health care