Services
Our flexible engagement structures are tailored to your needs, every step of the way – from Day 1 through commercialization. We offer:
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Access to an unparalleled network of cell and gene therapy leaders and innovators to support all aspects of the development and commercialization continuum
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Strategic consulting and related management services
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Comprehensive contract management services for emerging clients
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Clinical plan development
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Assessment reports
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Bioprocessing
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Analytical development
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Closed and automated processing
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Cost of goods analysis
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Evaluate options for in-licensing of pipeline assets
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Robust manufacturing platform
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CMO Management
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CMO selection
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Contract negotiation
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Ongoing management
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Process development
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Technology transfers
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GMP manufacturing
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Development and establishment of commercialization infrastructure
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Supply chain development
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Facility setup and FDA inspection
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IT Infrastructure
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Logistics for supply chain
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Regulatory submission
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Market access approach: billing code strategies
and pricing, reimbursement strategy
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Patient interface management
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Competitive differentiation
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Partnering strategies, IP
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Implementation of human capital strategies to build world-class capability
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HR due diligence including leadership team assessment
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Talent acquisition
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Organizational design and development
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Compensation and benefits plan design
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Creation of best-in-class culture
Cell One Partners partners with AES for designing cleanroom facilities.