Andrew Steinsapir

Andrew Steinsapir

CONSULTANT

Over 5 years of gene therapy experience, spanning upstream, downstream and analytical process development. Lean Six Sigma Green Belt.

About Andrew

Andrew holds a Lean Six Sigma Green Belt and has proven himself a leader in upstream, downstream, and analytical process development of gene therapies. At Dark Horse Consulting, Andrew leads efforts in creating process models that integrate technical, economic, and process engineering information to evaluate equity investment opportunities, risk and returns, as well as construct a more informed process/technology design.

Andrew also brings expertise in CMC, technology transfer, facility design, root cause analysis, Design of Experiments (DOE) and statistical analysis utilizing JMP software to advise cell and gene therapy companies on the most streamlined and robust methods to achieve their goals.

In 2014, Andrew joined 4D Molecular Therapeutics as the fifth member of the start-up team and soon became the first associate in the company’s process development group. He wore many hats at the company, participating in library generation, viral production, root cause analysis, development of batch records and SOPs, technology transfer and facility design. Andrew co-designed a 1,200 sq. ft. pilot plant and was responsible for training the entirety of the pilot plant staff. He also developed and iteratively improved a detailed techno-economic model of AAV manufacturing for the company.

At 4D Molecular Therapeutics, Andrew was involved in key IND-enabling process development studies, including DOE-based optimization of upstream and downstream unit operations (cell expansion, transfection, harvest, clarification, column chromatography and TFF).

He developed mid and downstream purification processes for a variety of AAVs, successfully completed technology transfer of all unit operations to the in-house pilot plant, and served as Person in Plant (PIP) for transfer of AAV manufacture to a CMO.

EXAMPLES OF RECENT WORK

  • Established tracking and trending program for a cell therapy company and cowrote comparability study report supporting Phase III manufacturing process changes.
  • Conducted audits and evaluated contract testing laboratories providing complex release assays for combination cell therapy products.
  • Provided Person in Plant (PIP) technology transfer support for a cell therapy drug product’s cGMP manufacturing transfer into a CMO.

PAST EXPERIENCE

4D Molecular Therapeutics
Senior Process Development Associate
Research Associate

EDUCATION

University of California, Berkeley
B.S. Chemical Engineering, emphasis in Biotechnology