Cedars-Sinai Biomanufacturing Center

Cedars-Sinai Biomanufacturing Center (CBC) is a 22,000 square foot, state-of-the-art biomanufacturing facility located in West Hollywood, California. The CBC is comprised of a cGMP cell manufacturing facility, housing multiple cleanroom cell production suites, and process development rooms for producing the next generation of cell and gene therapies.

These new therapies will be used for human IND-enabling clinical trials. With combined expertise and a cGMP-compliant approach to manufacture cells at scale, the CBC will overcome many challenges by building innovative technologies, connecting protocols, up-scaling of processes and achieving Food and Drug Administration standards for all steps involved to bring innovative cell therapy solutions to researchers and translation scientists. With our world-class expertise in stem cell (iPSC) biology, bioprocessing, translational medicine and manufacturing, the CBC is providing a much-needed biomanufacturing center in Southern California.

Our GMP manufacturing facility includes seven process suites for producing the next generation of cell and gene therapies. There is also nearly 5,000 square feet of dedicated adjacent cell culture lab space for incorporating practical stem cell training, practical modules and education of the next generation of scientists specializing in biomanufacturing.

To support scalable expansion of cells in defined cGMP-compatible media, we have the latest clinical-grade cell sorters, scalable bioreactor systems and automated cell harvesting.

Equipment in the CBC supports academic, clinical and commercial researchers and investigators to provide for the development and scalable manufacture of clinical-grade cell therapy products in compliance with current cGMP regulations suitable for investigational use in humans; development of iPSC-based and gene-edited cell products for research and drug discovery programs; and training of multiple individuals per week in iPSC and cGMP technologies.

Who we serve:

  • Cedars-Sinai faculty
  • External academic organizations
  • Commercial and industry clients

We expect to spur economic growth in regenerative medicine with innovative manufacturing in this region of clinical-grade regenerative therapies suitable for investigational use in humans.

Quality Policy

The CBC is committed to manufacturing the highest quality innovative cell and gene therapy products that meet or exceed our customers’ requirements and expectations. We apply good scientific practices to provide diverse quality products and services. As dedicated partners in biomanufacturing, we pledge to provide the highest levels of quality and safety of the manufactured products through robust and effective quality systems, process controls, rigorous performance criteria and testing.

We will strive to maintain compliance with cGMP regulations, with a focus on continuous improvement, monitoring and measurement of our core process metrics to ensure effectiveness.

Our Team

Leadership

Dhruv Sareen, PhD

Executive Director, Biomanufacturing Center, Executive Director, Induced Pluripotent Stem Cell Core Facility, Adjunct Associate Professor, UCLA, Department of Medicine, Assistant Professor, Biomedical Sciences

Peter S. Park, JD

Director, Business Operations, Tech Transfer

Advisory Board

Clive N. Svendsen, PhD

Governors Regenerative Medicine Institute, Kerry and Simone Vickar Family Foundation Distinguished Chair in Regenerative Medicine, Director, Board of Governors Regenerative Medicine Institute, Professor, Medicine, Professor, Biomedical Sciences

James D. Laur, JD

Vice President, Intellectual Property

Nicole Anderson Leonard, JD, MBA

Vice President, Research, Assistant Dean, Research

Nirdesh K. Gupta, PhD

Executive Director

Management

Loren A. Ornelas, MBA

CBC Manager

Business and Administration

Zachary Grodzinski

Manufacturing Coordinator

Itzel Sanchez

Senior Administrative Assistant

KiKi Hasson

Senior Administrative Assistant

Process Development and Manufacturing

Raquel Martin-Ibanez, PhD

GMP Manufacturing Manager

Lindsay Panther

Biomedical Scientist

Weidong Xiong, PhD

Biomedical Scientist

Aaron Frank

Biomedical Specialist

Emilda Gomez, MS

Associate Biomedical Scientist

Chunyan Liu

Associate Biomedical Scientist

Dylan West

Biomedical Specialist

Daniel Perez

Biomedical Specialist

Erick Galvez

Biomedical Specialist

Susan Lei

Biomedical Specialist

Imara Meepe

Biomedical Technician

Ruby Moran

Biomedical Technician

Louis Pinedo

Biomedical Technician

Joseph Roth

Biomedical Technician

Yunny Lopez

Biomedical Technician

Viviana Valencia

Biomedical Technician

Andre Cunningham

Materials Handler I

David Gutierrez

Support Services, Lead

Hojae Lee, PhD

Biomedical Scientist

Arwin Aghamaleky-Sarvestany, PhD

Associate Biomedical Scientist

Hanan Shaharuddin

Biomedical Specialist

Quality Assurance

Laura Jones, PhD, JD, MBA

Quality Assurance Manager

Akemi Daly

Quality Assurance Lead

Angela Chen

Quality Assurance Specialist

Quality Control

O'Dalee Balana

Quality Control Biomedical Scientist

Jonathan Rodriguez

Quality Control Manager

Ram Dodia

Biomedical Specialist

Richard Sato

Biomedical Technician

Carlos Maldonado

Biomedical Assistant

Operations and Facilities

Pankil Patel

Facilities Supervisor

Timothy Pontius

Maintenance Technician III

Jay Tharakulprateep

Maintenance Technician I

Contact Us

Click here to contact the iPSC Core and Biomanufacturing Center.