.02

SERVICES

• Strategic planning and tactical support for process development and manufacturing of:

  • Recombinant therapeutic protein products.

  • Recombinant food products.

  • Live Biotherapeutic (LBP) microbiome products.

• Evaluation of internal and external manufacturing processes.

• Evaluation and selection of external CMOs and CROs:

  • Authoring, issuing, and tracking of Request for Proposals (RFPs).

  • Evaluation and selection of CMOs and CROs based on issued proposals.

  • CMO\CRO site selection audits.

  • Oversight and management of interactions with selected CMOs\CROs.

• Leadership of biologics: manufacturing, process development, research, and project\program\portfolio management teams.

• Authoring of CMC reports, and CMC sections of regulatory filing.