Our Team

Mr. Kutner joined Biologics Consulting in May 2022 and has over 22 years of cell and gene therapy expertise, including 12 years of industry experience at platform-based biotech companies. He has direct experience in discovery, process and analytical development, vendor development, process characterization/validation, and authoring regulatory submissions. Mr. Kutner also has experience in nonclinical and clinical assay development. He supports process and analytical development for cell or vector products (Pre-IND through Phase III), developing functionality and genetic transfer assays for potency or mobilization of inserted vector, comparability study design and CMC regulatory filings as needed.

Robert previously worked for Avrobio as Head of Process and Analytical Development where he reverse tech-transferred external manufacturing for multiple ex-vivo gene therapy products. In addition, he established the comparability strategy for translating Investigator Sponsored Trials into the Avrobio Plato™ platform.
Prior to Avrobio, he worked for Rocket Pharmaceuticals as Head of Human Gene Therapy. In this role, he managed the establishment of CDMOs to support drug substance and drug product for multiple gene therapeutics.

Before Rocket, Robert worked for bluebird bio where he first gained his industry experience. As Head of Process Development, he was responsible for developing and scaling-up the rLV platform process to support multiple ex-vivo gene therapeuitics. His efforts followed through characterization and validation of these drug substances and included development of clinical and non-clinical assays. His procedures are currently in use for commercial production or testing of lentiviral vectors in multiple regions.

Prior to bluebird, he worked for LSU Medical School where he spent a decade researching scaleable processes and testing methods for viral vectors and vaccines. As Director of the Vector Core for the Gene Therapy Program, Robert gained his experiences on pDNA, rAd, rAAV, rLV, alphavirus, fowl-pox, and modified vaccinia platforms. Including the various typing and expression cassettes, he worked on well over 250 constructs and designed several production platforms.

Mr. Kutner has extensive experience in industrial scale production for cell and gene therapy. He is trained in GMP and can advise on best practices to implement during development of drug substances or drug products.

Education
Mr. Kutner received his B.S. in Chemistry from the University of Oklahoma in 1999.