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Clinical Research Cell Manufacturing Program (ISCI-CRCMP)

Interdisciplinary Stem Cell Institute

The Clinical Research Cell Manufacturing Program (CRCMP) exists to facilitate the translational development of cellular therapies from basic research projects to clinical practice.

The goal of the CRCMP is to provide the rapid and safe transition of basic research ideas. This includes the qualification and testing of reagents, scale-up of methods, development of Standard Operating Procedures (SOPs), ongoing process validation, and the provision of a controlled good tissue practice (GTP) and good manufacturing practice (GMP) infrastructure and support for compiling Investigational New Drug (IND) applications.

The CRCMP consists of three components: a) the Cell Production Facility (CPF), b) the Development Laboratory (DL), and c) the Pre-clinical Laboratory (PL). Processing of clinical products requiring long term culture is conducted in the CPF, while pre-clinical development and scale up procedures are undertaken in the DL. Production of cellular products for animal studies is performed in the PL and includes mouse, rat, and pig products for in vitro and in vivo studies and human cell products for studies in NOD/SCID mice.

The CPF occupies approximately 2,500 square feet on the 9th floor of the Biomedical Research Building, including 6 clean room labs, several other laboratories along with various laboratory support areas and office space. The designated Development Laboratory occupies 640 square feet and is conveniently located next to the CPF and the PL. The PL occupies 1344 square feet of laboratory space for production of animal cell products and isolation of cell lines for research studies. The translation of such therapies requires significant development and scale up to meet the stringent clinical standards required for patient infusion. The CRCMP provides the resources to do this in an effort to facilitate and expedite clinical trials in patients.

Facility Structure

  • 1 Clean Rooms with 6 tissue culture rooms and general clean room area
  • DL consists of 2 tissue culture rooms and general lab work area
  • 1 GLP research lab with 4 tissue culture rooms and general work area

The Clinical Research Cell Manufacturing Program (CRCMP)

Dr. Joshua Hare, MD, Professor of Medicine and Director, ISCI, oversees the CRCMP operations and provides the leadership on strategic planning for facility services. Reporting directly to Dr. Hare is Aisha Khan, Executive Director of Laboratory Operations of the ISCI Cell Processing Facility. Ms. Khan manages all projects of the cell processing facility. Under the direction of Aisha Khan, ISCI’s CRCMP has experienced substantial overall growth in clinical grade stem cell products. Our facility currently provides cell products for more than 20 clinical trials across the UM’s campus and collaborators from other intuitions. This growth is expected to continue throughout FY 2016 as we embark on developing new cell types, specifically umbilical cord blood derived stem cells. Additionally, we will increase cell production of our bone marrow derived stem cells to accommodate an NIH contract for the Cardiovascular Cell Therapy Research Network (CCTRN) – a nationwide network of seven centers conducting clinical trials of stem cell therapy for cardiovascular diseases. This new trial is internationally acclaimed for its use of a novel cell combination approach developed at ISCI.

Clinical research and pre-clinical research studies and cell productions are conducted under the supervision of Dr. Malik and Ms. Valasaki, both possess extensive experience in cellular manufacturing and research & development of novel products. CRCMP has a well-established and well maintained Quality Program under the direction of Ms. Longsomboon who has over 17 experiences in regulatory and quality assurance in the field. Dr. Bacallao supervises a team of scientists in conducting and developing techniques such as cells analysis, characterization and stability studies, etc.