Daniel Rodriguez-Granrose, Ph.D., PSM

SENIOR CONSULTANT

Brings 11 years bioprocess development and Quality by Design experience to help cell and gene therapy companies incorporate practical bioprocess considerations, quality target product profiles, process flow diagrams, risk assessments, unit operation technical reports, and design of experiments to efficiently build a design space in support of comparability protocols.

About Daniel

Daniel brings 11 years of biopharma and cell therapy industry experience to DHC. This experience includes successful transfer of multiple therapeutics into GMP manufacturing as process lead, commercial scale up of cell and viral cultures, serum-free media development, use of DOE for process optimization, and management of large cross-functional teams though each stage of bioprocess and CMC development.

Before joining DHC, Daniel worked as Senior Manager/Senior Scientist for DiscGenics Inc, where he led the Chemistry Manufacturing and Controls and Bioprocess Development teams. In this role Daniel devised and formally directed the company’s Quality by Design (QbD) efforts including the scientific rationale, bioprocess establishment and execution, regulatory considerations, and coordination between functional groups. Through use of multi-donor experimental design and analysis Daniel’s team built a true in multi-donor allogeneic cell therapy design space. Daniel’s group used this design space and computational fluid dynamics to scale their cell sphere bioprocess into 50L stirred tank reactors while maintaining critical quality attributes.

While at Sanofi Inc., Daniel led bioprocess development for 9 unique projects including the site’s highest priority project; he designed, operated, and optimized mammalian, insect, and viral processes from bench to industrial scale, ran 100s of bioreactors, and transferred successful processes from R&D to manufacturing.

Daniel received his PhD in Biochemistry and Molecular Biology from the University of Miami on the prestigious National Science Foundation Graduate Research Fellowship and his Professional Science Masters (a terminal biotechnology regulatory affairs and management degree) from the University of Georgia.

EXAMPLES OF RECENT WORK

  • Quality by Design Bioprocess Characterization for IDCT: An Allogeneic Cell Therapy for Lower Back Pain
    Daniel Rodriguez-Granrose The Bioprocessing Summit Boston (Conference Presentation)
  • Design of experiment (DOE) Applied to Artificial Neural Network Architecture Enables Rapid Bioprocess Improvement
    Daniel Rodriguez-Granrose, et. al https://doi.org/10.1007/s00449-021-02529-3
  • Transition from Static Culture to Stirred Tank Bioreactors for the Allogeneic Production of Therapeutic Discogenic Cell Spheres
    Daniel Rodriguez-Granrose, et. al https://doi.org/10.1186/s13287-021-02525-0
  • Identifying and Managing Sources of Variability in Cell Therapy Manufacturing and Clinical Trials
    Lara I. Silverman, Flagg Flanagan, Daniel Rodriguez-Granrose, et al. https://doi.org/10.1007/s40883-019-00129-y

PAST EXPERIENCE

DiscGenics Inc.
Sr. Manager/ Sr. Scientist, Bioprocess Development
Manager/ Sr. Scientist, Bioprocess Development
Sr. Scientist, Bioprocess Development

Sanofi, Inc.
Biologist, Bioprocess Development and Industrialization

EDUCATION

University of Miami
Ph.D. in Biochemistry and Molecular Biology

 University of Georgia
PSM in Biomanufacturing and Bioprocessing
Graduate Certificate in Biopharma Regulatory Affairs
B.S. in Applied Biotechnology

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