cGMP Cellular Therapy Manufacturing Facility
Translational Research Services
Laboratory for Advanced Cellular Engineering or LACE of Department of Pathology and Laboratory Medicine at NewYork-Presbyterian Hospital provides a new pharmaceutical capacity and support to generate experimental cell-based drug products in a setting of an academic institution. LACE brings many years of FDA/New York State regulatory expertise and manufacturing experience from an AABB/FACT/CAP accredited clinical cellular therapy laboratory to translate the cutting-edge research manufacturing protocol into an investigational new drug (IND) protocol for FDA approval. Adjacent to a clinical cellular therapy laboratory, LACE has expertise and shared access to characterize human cell products used for regenerative therapies. As a part of Weill Cornell Medicine core facility, LACE also benefits from having immediate access to other research core facilities for the purpose of conducting collaborative research as well as participating in grant applications.
Directed by Yen-Michael Hsu, MD, PhD, LACE will serve as a critical platform to provide feasibility and preclinical studies for engineered cell therapy product to be evaluated by FDA for human clinical trials. Partnering with various clinical divisions at Weill Cornell Medicine, LACE can provide rapid integration of the manufactured IND product into clinical trial pipelines at NewYork-Presbyterian Hospital/Weill Cornell Medical Center.
The LACE contains 3 ISO 6-7 clean room compartments, including the ISO 6 central processing room (30+ air changes per hour with 100 percent new HEPA-filtered air). It has a unique 14-foot long cGMP grade cell processing isolator (ISO 5) that allows hypoxic cellular manufacturing and culturing by multiple concurrent operators. This module is controlled and monitored 24/7 for environmental settings that are customizable. Specialized cell separation, counting, washing and cryopreservation equipment are available in an adjacent laboratory. Equipment and critical facility parameters are continuously monitored via a wired alarm system, with on and offsite surveillance and data collection. Environmental and production monitoring are performed by the LACE cGMP Quality Control Program. Materials and equipment used during manufacturing are tracked and monitored for expiration and calibration records. Quality Assurance provides oversight of manufacturing and facility operations.
LACE Staff Members
Yen-Michael S. Hsu, MD, PhD – Laboratory Director
- Assistant Medical Director of Cellular Therapy Laboratory (2014 - present)
- AABB Cellular Therapy Accreditation Program Member (2015 - present)
- FACT Processing Laboratory Inspector (2016 - present )
Lee McDonald, PhD –Project Leader and Head, Laboratory Quality
- 20+ years of investigational product development and cGXP QA experience
Jae-hung Shieh, PhD –Technologist Specialist
- 30+ years of post-doctoral research experience in hematology and regenerative medicine
Please submit a project request to better estimate the project-specific usage.
Specialized Human Cell Processing Equipment
COBE 2991 Cell Washer
BD FACSCanto II
Control Rate Freezer
Dry cell thawer
Cell culture incubator
Vapor-phase stationary or mobile liquid nitrogen containers
Melissa M. Cushing, MD, Medical Director of Transfusion Medicine and Cellular Therapy Laboratory
Gina L. Imperato, Administrator
Jeffrey Hernandez, Finance and Operation Administrator
Kathleen Crowley, Manager of Blood Bank and Cellular Therapy Laboratory
Michael Ancharski, Supervisor of Cellular Therapy Laboratory
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
Laboratory for Advanced Cellular Engineering (LACE)
525 E. 70th Street, M-038
New York, NY 10065
Tel: (212) 746-2212
Fax: (212) 746-8435
Submitting a Project
To request technical and/or professional services from the LACE in the Department of Pathology and Laboratory Medicine at NewYork-Presbyterian/Weill Cornell Medical Center, please first create a Cornell iLab account (email: iLabfirstname.lastname@example.org). Once an account has been created, use your user name and password to submit a request. All required information must be completed, including your account number for billing (for internal requests). Prior IRB approval must be received in order to process any requests involving tissue samples.
Upon the director’s approve, a project number will be assigned to you. If you have any questions, please contact Lee McDonald via email (email@example.com) or at (212) 746-1810.