Elina Linetsky, Ph.D., is an expert in product / process development, scale-up cGMP production and cell therapy manufacturing for clinical applications, as well as regulatory affairs. She has a broad background in aseptic methods of cell manipulation which include gene transfer, cloning and sub-cloning, ex-vivo cell culture and expansion, selection and purification of desired cell populations, immunoisolation, harvesting, storage and cryopreservation, and characterization of human cells. In addition, she has extensive regulatory and compliance experience, and comprehensive knowledge of current ISO, FDA, EU and IRB regulations.
In 1994, she joined the Diabetes Research Institute (DRI) at the University of Miami (UM) where she served as the manager of human cell processing laboratories dedicated to human islet and bone marrow cell processing for clinical applications. During her tenure, she was instrumental in overseeing the preparation of over 500 islet cell and bone marrow transplants. In the year 2000, she switched her focus from clinical applications to basic research, to work in the area of tolerance induction to the islet graft via donor-specific bone marrow transplantation. Her work resulted in several publications in peer-review journals. In 2004, she returned to the cGMP Cell Processing Facility, and Clinical Islet Transplant Program (CITP) as the Director of Quality Assurance (QA) / Regulatory Affairs. In this role - and working closely with DRI, UM and other scientists / physicians, and commercial companies – she lead the scale-up, validation and translation of promising new therapeutic technologies from preclinical level into clinical-grade processes. These were utilized to manufacture cell-based and/or tissue engineered products for clinical applications. In 2013, Elina was asked to take over the operations of the cGMP Cell Processing Facility. In this capacity she’s been working to streamline product development processes, manufacturing activities, QC and QA issues, and fiscal performance of the facility.
Applying her detailed knowledge of ISO, FDA and EU regulations, Elina oversaw development of comprehensive QA system in the DRI cGMP which lead to the accreditation of the facility by FACT and AABB, for manufacture of both minimally and extensively manipulated products. She was also instrumental in the development of regulatory strategy for a number of cellular therapy and combination products, and various regulatory documents which include but are not limited to IND and IDE for biologics, devices and combination products; DMFs; FDA annual reports; IRB documents, etc. As a consultant and an inspector for FACT and AABB Elina continues to provide guidance to a number of cGMP Cell Therapy facilities around the nation and abroad, which are at different time points of their life cycle with respect to FDA compliance and accreditation by various agencies.
Elina is a strong advocate for the importance of regulatory requirements and actively contributes to their implementation. She is well published in the area of islet cell transplantation and regulatory approaches applicable to the manufacture of allogneic / autologous islet cells and other cellular therapeutics that can be implemented by a wide range of cell therapy processing facilities and transplant centers building their programs from the ground up.