Jacob Staudhammer

CONSULTANT

Bioengineer with 5+ years of experience focused on gene therapy viral vector process development as well as characterization and validation with an emphasis on AAV and lentiviral vectors.

About Jacob

Jacob joined Dark Horse Consulting in 2021, bringing over 5 years of experience in the Biotechnology industry, primarily focused on process development and characterization of gene therapy viral vectors from early pre-clinical development to design of PPQ campaigns.

Jacob held increasing roles at Adverum Biotechnologies in the Process Development group, focusing on Upstream and Downstream development of Adverum’s SF9-Baculovirus AAV process. While in these roles, Jacob also developed several novel methods for advanced AAV analysis using NGS and DLS, and led the development of a patented PCR-based analysis method.

While at Orchard Therapeutics, Jacob focused on the Process Validation and Process Characterization of late-phase Lentiviral Vectors (LVV) for Orchard’s rare disease portfolio. He oversaw the Process Characterization and PPQ strategy using a Quality-by-Design approach, including conducting risk assessments, setting PPQ specifications, and overseeing root cause analyses for the late phase program. In addition to these responsibilities, Jacob supported external manufacturing activities such as authoring and improving SOPs and Batch Records and serving as person-in-plant for multiple manufacturing runs. Throughout the successful Process Characterization, he designed and authored several Process Characterization protocols, reports, and assessments to develop an effective Process Control Strategy.

During his time at CODA Biotherapeutics, Jacob led the Process Development for the scale-up and optimization of a suspension HEK-293 process for AAV production. He worked with and audited several external manufacturing organizations to finalize MSAs and development strategies in support of clinical AAV manufacturing.

EXAMPLES OF RECENT WORK

  • Set meaningful process and release specifications using statistical analysis in JMP
  • Authored the PPQ protocols and strategy for a late stage LVV process
  • Used DOE to design effective process characterization protocols
  • Participated in CDMO audits and served as person-in-plant
  • Implemented novel AAV and LVV analysis methods for in-process analysis

PAST EXPERIENCE

CODA Biotherapeutics
Senior Process Development Engineer

Orchard Therapeutics
Senior Engineer, Process Validation

Adverum Biotechnologies
Engineer II, Process Development

EDUCATION

Oregon State University
B.S. in Bioengineering (Cum laude) with minors in Mathematics and Bioenergy

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