Cell and Gene Therapy Manufacturing

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Affiliation:

IU School of Medicine / IUPUI

Director:

Emily Hopewell, PhD, CABP(H)

Bioprocess Development Laboratory Lead::

Quynh-Mai Trinh, MS

Cell Immunotherapy and Transduction Director:

Emily Hopewell, PhD, CABP(H)

Cell Immunotherapy and Transduction Manager:

Chistina Vaughan, MS, CABP

Vector Production Facility Director:

Daniela Bischof, PhD

Vector Production Facility Manager:

Alisha Moore, BS

Vector Production Facility Manager:

Aaron Shaw, PhD

Description:

The Cell and Gene Therapy Manufacturing (CGTM) Facility collaborates with investigators to translate cell and gene therapy to patients, from consultation on pre-clinical design through manufacturing of early phase products for patients. The team is under the direction of Emily Hopewell, PhD, and comprises the Cell Immunotherapy and Transduction Facility (CIT), the Vector Production Facility (VPF), and the Bioprocess Development Lab (BDL). All areas share a unified Quality Management Plan and Quality Assurance team. The VPF has an ISO 7 classified space with multiple suites for manufacturing following GMP and operating under BSL-2 with BSL-3 practices. The VPF collaborates with the IU Gene Therapy Testing Laboratory (GTTL) for certification testing. The CIT has an ISO 7 classified space with multiple suites and operates under BSL-2. The CIT has a quality control laboratory for in-process and release testing of products, including endotoxin testing, flow cytometry, cell culture assays, and ELISA. Additional testing is provided through the IU GTTL and vendors.

Policies:
Services:
  • GMP Consultation

    • Preclinical study design and reagents
    • IND support, including Chemistry, Manufacturing, and Control document preparation
    • Grant support for project design and budget estimates
  • Bioprocess Development

    • Technology transfer and optimization
    • Scale up/scale out
    • Process and analytical development
  • Vector Production Facility

    • Preclinical mid-scale vector manufacturing
    • Master cell banks for viral vectors
    • Clone development for master cell banks
    • Retroviral vectors
    • Lentiviral vectors
  • Cell Immunotherapy and Transduction Facility:

    • Cell selection
    • Cell activation and expansion
    • Genetic modification
    • CAR-T manufacturing
    • Viral Specific T Cell manufacturing
    • CliniMACS Prodigy automated processing
    • Formulation and cryopreservation
    • Dose preparation
    • Product testing and release for clinical use
  • Regulatory support
  • Product release and distribution
Contact: