Robert H. Kutner Email & Phone Number

Alexandria, Virginia, Us

Serves as an advisor for CMC, including process and assay development, vendor development, and process characterization/validation.- Experienced with GMP and can advise on best practices to implement during development of drug substance or drug product.- Creates strategy and development timelines. - Author and Review regulatory submissions.

Cambridge, Massachusetts, Us

Built out process and analytical development laboratory and team which consistently delivered on every corporate goal and department objective. Primary activities focused on comparability studies for investigator sponsored trials and establishing representative systems for external procedures.- Designed comparability study to translate the academic sponsored ex vivo cell therapy clinical trial for Cystinosis disease into Avrobio’s Plato process. The executed and completed study was approved by the Food and Drug Administration (FDA) without remark. Responsible for writing Module 3 of the investigational new drug (IND) amendment.- Established CMC analytical platform and Avrobio Plato process capabilities around contract manufacturers for Fabry, Gaucher, Pompe, and other undisclosed disease indications.- Directed the comparability study to translate the academic sponsored clinical trial for Hunter’s disease into the industrial Avrobio Plato process.- Set up phase appropriate policies, standard operating procedures (SOPs), and document control systems for compliant study plans, procedures, and study reports.- Led replication competent lentivirus testing development for research and development (R&D), CMC, and clinical to support broad regional regulatory body requirements, including shed vectors for the Cartagena Act.

Cranbury, New Jersey, Us

Led clinical translation and comparability efforts for industrialized good manufacturing practice (GMP) production of recombinant lentivirus for ex vivo based hematological trials in Fanconi Anemia, Leukocyte Adhesion Deficiency-I, Infantile Malignant Osteopetrosis, and Pyruvate Kinase Deficiency. Developed the CMC strategy for the direct inject in vivo AAV based Danon disease program. - Established internal and external systems for upstream and downstream processes for pDNA, LV/AAV, and cell production.- Planned ready-to-execute budgets for the buildout of multiple facilities with an aim to provide an appropriate manufacturing assessment of build-vs-contract approaches.- Internally built and resourced systems enabling the rapid progression of platform advancements under quality systems which governed document and version control.- Established multi-compendial drug substance and drug product processes, which included starting materials such as the bacterial banks, plasmids, and eukaryotic packaging cells.- Oversaw vector transcript and capsid designs for the Danon disease AAV program and established a vendor-based production for the direct inject in vivo grade final drug product.- Designed CMC portion of tox studies for incoming programs and supported good laboratory practices facility searches.

Somerville, Massachusetts, Us

Responsible for core CMC lentiviral vector manufacturing activities which included process characterization and preparations for process validation of the Zynteglo, Skysona, and Abecma drug substances. Activities also included translating preclinical and academic studies for facile development. Broadened the horizontal strategic platform with build out of process research for mRNA production.- Directed functions structured into three verticals: Upstream process development, downstream process development, and process characterization and validation. -- Created a cross-functional matrix with a defined set of teams, fostering growth and leadership within the separate crucial functions for analytics and manufacturing.- Managed good manufacturing practices (GMP) designated vendors of all lentiviral vectors and their associated raw and starting materials, which included biorepository and traceable transport of active investigational products.- Supervised creation of the Validation Policy and Process Validation Master Plans for pDNA and lentiviral vector.- Established pDNA process characterization and validation campaigns at vendor to enable PC/PV of lentiviral vector.- Built process research laboratory for production, purification, and analytics of mRNA using in vitro transcription for upstream production and UPLC for downstream purification.

Somerville, Massachusetts, Us

Lead scientist focused on development of ex vivo applications of lentiviral vectors for Phase I/II and Phase II/III autologous cell therapy-based programs. - Managed successful campaigns developing scalable sterile grade GMP lentiviral production to support ongoing clinical trials and the preclinical pipeline.- Secured compliance to regulatory agencies by developing or supporting document version control, change controls, executed batch record reviews, deviations, corrective and preventive actions (CAPAs), and investigations.- Created strategy for multiple vendor tech-transfer activities and preparations for commercial suites.- Finalized process development and GMP batch development and production records.- Developed first industrial validated final 0.2um sterile fill/finish process for lentiviral vector.- Researched and submitted patent techniques for thermo and cryo stabilization of vectors.- Researched and submitted patent for vectorizing RNA-dependent-RNA-Polymerase eukaryotic expression. - Authored relevant sections of regulatory filings for CMC modules of Investigational Medicinal Product Dossier (IMPDs) and INDs.- Drove culture of cooperative support and fostered an encouraging environment for individuals to become themselves while supporting the common goal of making hope a reality for patients.

New Orleans, La, Us

Led technical and administrative activities for the government funded Gene Therapy Program’s Vector Core. Rebuilt the facility following Hurricane Katrina to provide a portfolio of services around recombinant plasmids, adenovirus, adeno-associated virus, alphavirus, Fowl Pox, Modified Vaccinia Ankara, retrovirus, and lentivirus-based vectors for use in elucidating mechanisms, R&D of therapeutics, or prime and boost vaccination studies. - Expanded vector portfolio by establishing recombinant Modified Vaccinia Ankara and Fowl Pox.- Established in vivo vaccine grade plasmid production via inducible fed-batch stirred tanks.- Provided consultation services, technical documentations, vector vehicle selection, plasmid construction, vector manufacturing, and data interpretation.- Vector production research focused on scaling rLV, rAd, and pDNA purification using inline methods for an end-to-end closed vector production system.- Developed bioreactor-based processes to vertically scale upstream production.- Fashioned a custom peristaltic system for scalable downstream handling.

New Orleans, La, Us

Senior Research Associate (RA), Gene Therapy Program Vector Core (8/2003 – 9/2005)Led core operations and established large-scale pseudotyped lentivirus production and concentration. Research emphasized purification of lentivirus with aims to transduce target tissues more efficiently while maintaining scalability. Explored various lentivirus systems and established high-titer culture procedures through enhanced transfection methods and clonal selection of various producer cell lines.Research Associate II, Gene Therapy Program Vector Core (5/2001 – 8/2003)Constructed and produced large-scale rAd preparations following standard operating procedures. Activities included molecular cloning, cell culture, purchasing equipment and supplies, and method development. Established new protocols to quantify rAd by HPLC and real time PCR, and developed methods to score for rescue of replication competency and HPLC purify rAd using a Unicorn based AKTA purifier.

Midland, Michigan, Us

Contract analytical chemist during the acquisition of Union Carbide assigned to perform quality control for industrial scale GMP manufacturing of biodegradable plasticizers. Followed wet chemistry or gas chromatography standard operating procedures (SOPs) to analyze test samples from starting reagents, materials in-process, or final products. Maintained and calibrated 25 gas chromatography units, an atomic absorbance unit, and various other equipment and materials to ensure proper compliance for large-scale chemical refinement.