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Cell and Gene Therapy

The Cell and Gene Therapy Manufacturing and Testing group is poised to translate research into investigational products used to treat patients in clinical trials. From development to clinical trials, we work with investigators to ensure that patients receive safe, high-quality products and the long-term safety testing required for gene modified clinical trials. The Cell and Gene Therapy Manufacturing and Testing team provides lentiviral, retroviral vector and cell manufacturing, and testing services to enable early-phase cell and gene therapy trials. Our renowned viral vector manufacturing and testing groups have been providing these services for over 30 years, facilitating the transition from science into patient treatments.

Video

Providing access to cutting-edge cell and gene therapy

Emily Hopewell, PhD, explains how the Department of Medical and Molecular Genetics plays a pivotal role in bringing research from investigators into the clinic to treat patients and offer access to cutting-edge therapies in clinical trials.

Faculty and Staff

14772-Bischof, Daniela

Daniela Bischof, PhD

Assistant Professor of Clinical Medical & Molecular Genetics

Director, IU Vector Production Facility

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63488-Dang, Thao

Thao T. Dang, PhD, MS

Assistant Professor of Clinical Medical & Molecular Genetics

Assistant Director, Gene Therapy Testing Laboratory

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42551-Hopewell, Emily

Emily L. Hopewell, PhD

Assistant Professor of Clinical Medical & Molecular Genetics

Director, Cell and Gene Therapy Manufacturing
Director, Cell Immunotherapy and Transduction Facility
Director, Gene Therapy Testing Laboratory

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Andrea Gunawan

Business Manager, Gene Therapy Testing Laboratory

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Jamie Irwin

Business Manager, Cell and Gene Therapy Manufacturing

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Tyler Checkeye

Quality Assurance Specialist, Cell Immunotherapy and Transduction Facility

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John Niehaus

Quality Assurance Specialist, Gene Therapy Testing Laboratory

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Shawn Paller

Quality Assurance Specialist, IU Vector Production Facility

Services

Good Manufacturing Practices consultations

  • The faculty and staff can provide consultation on regulatory requirements to meet Good Manufacturing Practices (GMP) for early phase trials.
  • Preclinical study design and reagents
  • Grant support through study design and budget preparation
  • Process and assay development
  • Feasibility studies and engineering studies
  • Regulatory document preparation for chemistry, manufacturing, and controls sections of Investigational New Drug Applications

Labs and Facilities

The Bioprocess Development Laboratory provides services for scale-up, translation and optimization of processes for manufacturing readiness. This includes technology transfer, process development, analytical development, scale up and scale out.

Contact QuynhMai Trinh, laboratory manager, at qtrinh@iu.edu for more information.

The Cell Immunotherapy and Transduction Facility has classified spaces to meet manufacturing requirements and a quality control testing laboratory for identity, safety and functional testing of cellular products.

Manufacturing services:

  • Cell activation and expansion
  • Cell enrichment on the CliniMACS Prodigy
  • Genetic modification
  • Formulation and cryopreservation

Testing services:

  • Flow cytometry
  • Cell counting and viability
  • Safety testing, including sterility testing and autonomous growth testing
  • Functional testing, including cytotoxicity assays

Contact Emily Hopewell, facility director, at emlhope@iu.edu for more information.

The Gene Therapy Testing Laboratory provides testing services to academic and commercial sponsors.

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The IU Vector Production Facility manufactures master cell banks, lentiviral vectors and retroviral vectors for academic and commercial sponsors. The facility consists of four manufacturing suites classified to meet regulatory requirements for early-phase manufacturing.

Manufacturing Services:

  • Preclinical vector manufacturing (engineering runs/IND-enabling products)
  • Master cell banks
  • Retroviral vectors
  • Lentiviral vectors

Contact Daniela Bischof, facility director, at dabischo@iu.edu for more information.