Client-Facing Readiness

Client: Public-private consortium supporting the commercialization of cell and gene therapies.

Cell One Partners Role: Prepared client for successful engagement with customers including the positioning and offering of process development and manufacturing capabilities and streamlining business development and client engagement processes.

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CDMO Relationship and Regulatory Guidance

Client: Cell therapy development company focused on educating immune system cells to eliminate cancer.

Cell One Partners Role: Assisted with selecting and subsequently managing client’s relationship with select CDMOs and supporting engagement with regulators.

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Due Diligence for an Investor

Client: Internationally known investment fund.

Cell One Partners Role: Supported due diligence initiative, providing expert points of view, a global positioning review based on in-depth interviews with key opinion and industry leaders, internal capabilities assessment and overview of immediate and longer-term prospects.

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Strategic Prioritization

Client: Immune system profiling company.

Cell One Partners Role: Provided strategic guidance related to client offerings and attendant regulatory issues. Focused on development of phase appropriate manufacturing platforms and gap analysis of its current quality systems, controls, cGMP-compliant processes and relevant remediation programs.

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Market Entry Strategy

Client: Emerging cell and gene therapy company.

Cell One Partners Role: Advised on facility development strategy, organizational needs, regulatory requirements, logistic considerations and financial investment requirements.

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