Production Assistance for Cellular Therapies

The University of Minnesota Molecular and Cellular Therapeutics Facility (MCT) has been selected as one of the 5 Cell Processing Facilities offering translational services and cell product manufacturing for pre-clinical studies to investigators at no charge under the National Heart, Lung, and Blood Institute-funded Production Assistance for Cellular Therapies (PACT) program.  The PACT program is in its second renewal and has been providing services to cell therapy investigators since 2003.  For more information please visit www.pactgroup.net

The 5 PACT Cell Processing Facilties & Coordinating Center are:

  • University of MInnesota Molecular and Cellular Therapeutics (MCT), HHSN268201600014I
  • Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine, HHSN268201600015I
  • Center for Biomedicine and Genetics, City of Hope, HHSN268201600011I
  • Interdisciplinary Stem Cell Institute Cellular Manufacturing Program (ISCI-CMP), Miller School of Medicine, University of Miami, HHSN268201600012I
  • Moffit Cancer Center and Research Institute, HSN268201600013I
  • Coordinating Center-The Emmes Corporation, HHSN268201600020C

Scope of Projects:

PACT's objective is to promote the advancement of cellular therapy research in the areas of regeneration of damaged/diseased tissues, organs, and biologic systems, and targeted treatments for serious diseases without effective therapies in support of the NHLBI's program areas of interest:  cardiovascular, pulmonary, blood, hematopoietic, and stem cell disorders.  For qualifying areas of interest, please see the PACT Application: Scope Criteria located at www.pactgroup.net.  

University of Minnesota PACT Program Personnel:

David McKenna, MD
Principal Investigator
MCT, Scientific & Medical Director
Clinical Cell Laboratory Director
 
Jeffrey Miller, MD
Co-Investigator
Director, Cancer Center Experimental Therapeutics Initiative
 
Diane Kadidlo, MT (ASCP) SBB
MCT, Facility Operations Director
 
Shelley Pulkrabek, MT (ASCP) CCRC
Program Coordinator
 

Specifically, the PACT program at the University of Minnesota can:

  • Manufacture master and working cell banks
  • Provide customized cell selection procedures
  • Assist in assay development for determination of cell potency
  • Assist in the standardization of challenging tests; for example, functional assays for cell homing or migration and immune monitoring
  • Facilitate the distribution of products that cannot be shipped long distances
  • Serve as a central QA/QC laboratory for multi-center studies
  • Support pre-clinical studies including work with animal and human cell in relevant animal models
  • Support development of IND/IDE applications

Manufacturing capabilities include:

  • Cardiac progenitor cells
  • Peripheral Blood, Bone Marrow, and Umbilical placental/cord blood hematopoietic cells
  • iPSC progenitor cells
  • Mesenchymal (bone marrow, umbilical cord blood/tissue)
  • Dendritic cells
  • Large multivalent immunogen (LMI) vaccine (allogeneic)
  • PB-derived activated NK cells, CD4/CD25 T regulatory cells
  • Mesenchymal stem cell master and working cell banks
  • Cell Depletion/Cell Enrichment of CD3/CD19 depletion, CD14 selection, CD34 selection, CD56 selection, and TCR-alpha/beta depletion
  • Cell culture expansion and cryopreservation technologies
  • Counterflow elutriation
  • Cytokine capture technology
  • Donor leukocyte infusion

Application process:

  • Online preliminary application found on the PACT website
  • Evaluation by Steering Committee
  • Submission of full application
  • Approval of budget and timelines
  • Product manufacture begins

 

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