COMPANY PROFILE


"Bringing Therapies to Life"

Strategic Quote


“Every customer and project is unique, but our overarching approach remains the same: exceptional service to customers and dedication to bring their medicine into the clinic or to BLA.”

Summary


Genezen is a best-in-class gene therapy CDMO with over a decade of experience focused on supporting the demands of the cell and gene therapy manufacturing market worldwide. With capabilities across vector-modalities (AAV, lentiviral, retroviral, and others), Genezen partners with innovator organizations to deliver potentially life-saving gene and cell therapies – from concept to commercial. With flexible and customer-centric programs, Genezen tailors its partnership-model approach to all sizes and stages of organizations, to make viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen’s state-of-the art Lexington, MA site holds multiple global regulatory licenses, including with the FDA, EMA, Health Canada, and MFDS Korea, in support of active manufacture of a commercial viral vector-based product. Our Indianapolis, IN site provides cGMP manufacturing for viral vectors and is currently supporting a program entering a pivotal clinical trial.

Development and Manufacturing Solutions


Genezen is your comprehensive CDMO partner for viral vectors. We offer a wide range of services:

  • Process Development

o Research Use Only (RUO) material production o Cell line development o Research cell bank generation o Process Pilot Runs

  • Analytical Services

o Method development o Method transfer o Method qualification o Method validation o Stability studies

  • cGMP Manufacturing Services

o cGMP cell bank generation o cGMP vector Drug Substance manufacture and release o cGMP Drug Product manufacture and release o Cell Therapy Manufacturing (through a 3rd party partner)

  • Regulatory & CMC Support

Genezen is dedicated to exceptional gene and cell therapy, offering guidance, expertise, ​technology, and manufacturing capacity to help bring your viral vector-based therapy to life.

Our Team


  • Steve Favaloro, Chairman & Chief Executive Officer

Steve Favaloro is an experienced biotech executive, board member, and investor. He is an executive advisor at Ampersand Capital Partners, a leading healthcare investor, and also serves on the boards of Vernal Bio and Biologics, and is on the board of advisors at Life Science Cares Boston. Prior to Genezen, Steve was CFO at Arbor Biotechnologies, a next-generation gene editing therapeutic company. Steve also served as CFO at Arranta Bio, a leading CDMO for mRNA, from its founding in 2019 to its successful exit to Recipharm in February 2022. Prior to this, Steve was CFO at Brammer Bio, where he oversaw a period of rapid expansion and capital deployment from 2016 to 2019 – leading up to its successful sale to Thermo Fisher Scientific in May 2019 for $1.7B. Before joining Brammer, Steve held finance roles of increasing responsibility at MilliporeSigma, Merck KGaA, and Bruker Corporation. He received his MBA and Master of Science from the Carroll School of Management at Boston College. Steve also received his Bachelor of Arts degree in Economics from Boston College.

  • Susan D’Costa, Chief Technical & Commercial Officer

Susan D’Costa is a molecular virologist spanning 25 years of experience in virology. Over the past twelve years she has translated her expertise into viral vector gene therapies where she has been actively involved in viral vector analytics, process development, manufacturing, and building successful teams. She serves as a board member for Elly’s Team, a parent foundation focused on accelerating the translation of medical research into treatments. She also serves on the Scientific Advisory Board for Precision Biosciences, a clinical-stage biotechnology company focused on developing genome editing therapies using its proprietary ARCUS® platform. Prior to Genezen, Susan was CTO at Alcyone Therapeutics, a biotechnology company pioneering next-generation CNS precision gene-based therapeutics for complex neurological conditions. At Alcyone, she was responsible for viral vector CMC, device development operations and partnering on new technologies for both gene therapy and precision delivery. Dr. D’Costa has also held leadership roles of increasing responsibility at Thermo Fisher Scientific, Viral Vector Services and its predecessor companies – Brammer Bio and Florida Biologix, working with different viral vectors, liaising with diverse biotech clients and building teams with scientific and operational excellence. Susan holds a Ph.D. in biology, specializing in molecular virology, from Texas Tech University; an MS in biochemistry from Mumbai University (Grant Medical College) and a BS in microbiology/biochemistry also from Mumbai University (St. Xavier’s College).

  • Mike Wourms, Chief Operations Officer

Michael Wourms[MB2] is an experienced CDMO leader with deep expertise in advanced therapeutics and a strong record of scaling business operations. He most recently served as COO of Arranta Bio and Vibalogics, overseeing three sites across the U.S. and Europe. At Arranta, he led the launch of a first-in-kind commercial microbiome facility, growing the team from two to over 250, and established an end-to-end RNA supply chain. After Arranta’s acquisition by Recipharm in 2022, he took over operations at Vibalogics, managing 300K ft² of capacity and 400 employees across the U.S. and Germany.

Previously, Michael held roles at ElevateBio and Brammer Bio, where he led clinical manufacturing, doubled capacity, built leading drug product capabilities, and supported Brammer’s acquisition by Thermo Fisher in 2019. He began his career in experimental hematology and cancer biology at Cincinnati Children’s Hospital. Michael holds a B.S. in Biological Sciences (Immunology) and an M.S. in Pharmacology and Toxicology from Wright State University in Dayton, Ohio.

Mission & Values


Derived from the Dutch word meaning “to cure,” the Genezen name reflects our shared mission to deliver life-changing viral vector-based therapies to patients worldwide.

  • Mission: We are driving the advancement of cell and gene therapies by providing science-driven development and manufacturing solutions.
  • We are guided by our CURES values:

o Committed to scientific excellence o Urgency in our action for patients o Resilience and grit in our operations o Execute with excellence and integrity o Solutions driven for our partners

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