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.
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.
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.
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.
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.