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Michael Laird - Vice President & Principal Scientist, Process Development

Michael Laird

Vice President & Principal Scientist, Process Development

Postdoc Mentor
"We are responsible for developing clinical and commercial manufacturing processes for therapeutic proteins."
17
Years at Genentech
31
Publications

We are responsible for developing clinical and commercial manufacturing processes for therapeutic recombinant biomolecules using Chinese Hamster Ovary (CHO) and E. coli cells. We also develop & evaluate new bioprocess technologies both internally and through industry and academic collaborations to improve our manufacturing processes. Our laboratories and pilot plants are housed within the Cell Culture and Bioprocess Operations department as part of the Pharma Technical Development (PTD) organization, which serves as the bridge between research & manufacturing. Our scale of operations ranges from a few mL for research-supply materials up to 1,000L for pilot-scale production. Our operations additionally encompass the pilot-scale facilities and staff to purify & formulate biomolecules into drug substance (DS) and drug product (DP).

Additional activities in our laboratories include but are not limited to:

  • Develop highly-productive targeted integration CHO host cell lines
  • Optimize transient and stable cell cultures processes for research materials production for gRED (Genentech Research and Early Development)
  • Media development & optimization for cell culture processes to improve cell growth, product yield & product quality
  • Develop techniques to improve control of product quality attributes
  • Proteomic & genomic analyses to enhance our understanding of how the culture environment influences the recombinant biomolecule production process
  • Scale-independent & scale-dependent validation for our manufacturing processes
  • Transfer of processes to manufacturing sites within the Roche network and to contract manufacturing organizations (CMOs)
  • Develop new single-use technologies & manufacturing network standards
  • Prototype & characterize technologies for deployment into manufacturing
  • Evolve our digital tools to enable data science and analytics

Featured Publication

Mechanism of antibody reduction in cell culture production processes.

Biotechnol Bioeng. 2010 Jun 29.

Kao YH, Hewitt DP, Trexler-Schmidt M, Laird MW.