Progenitor Cell Therapy (PCT) Manufacturing Facility, Allendale, New Jersey, United States of America
Progenitor Cell Therapy (PCT) launched phase one of a new cell development and manufacturing facility on 26 January 2010. Located in Allendale, New Jersey, the new facility will develop human cells for therapeutic use. It will support PCT's contract manufacturing of cell-based therapeutic products.
PCT currently operates from two facilities, including a self-owned facility in Hackensack and a leased facility located in Mountain View, California.
The new facility will combine all PCT's operations in one location. In addition to providing for the initial installation of a freezer farm, the facility will serve as the new headquarters of PCT. It is fully compliant with the FDA norms and meets the requirements set by the European Medicines Agency (EMEA).
Designed to support process and product development, including phase one, two and three clinical trials, fill and finish operations, and commercial product manufacturing, the facility will provide services to the current and future clients of PCT.
New cell development and manufacturing facility
The state-of-the-art facility is a 30,000ft² area housing several clean room manufacturing suites. Each suite is equipped with separate air handling and laboratory systems. There is an installed freezer farm unit with multiple liquid nitrogen (LN2) freezers. Equipped with monitoring and control capabilities, the unit is designed to provide efficient storage capacity for the developmental cell lines and candidate therapies of PCT's clients.
PCT's 2,500ft² Hackensack facility is located in the campus of the Hackensack University Medical Center (HUMC). It was previously an operational hematopoietic progenitor cell and tissue processing laboratory of HUMC. PCT acquired the facility in 1999 during the company's launch.
The facility features 1,150ft² of clean room manufacturing suites classified as ISO Class 7 / Class 10,000 or ISO Class 8 / Class 100,000. The suites maintain the highest standards of air flow and quality required for the development and clinical trial of human cells.
Around 3,300ft² of space has been devoted for a fully-equipped QC laboratory, and pre-clinical research and development area. Between 1995 and 2005 the facility conducted in excess of 14,000 cell therapy procedures, including more than 6,500 umbilical cord blood products. It can currently process more than 1,300 products each year.
The Mountain View facility has approximately 25,500ft² of space for ISO Class 7 / Class 10,000 or ISO Class 8 / Class 100,000-classified clean rooms, office and support rooms. It also has free space that can be used to build additional clean rooms according to customer requirements.
Both facilities are fully compliant with the accreditation requirements of the Foundation for the Accreditation of Cellular Therapy (FACT). They are also compliant with the Current Good Manufacturing Practices (cGMPs) and the Current Good Tissue Practices (cGTPs) of the FDA. In addition, the facilities comply with the regulatory and licensing requirements as mandated by the state and the federal government.
PCT's manufacturing facility construction
The new facility will be constructed in multiple phases. Phase one, including the construction of a freezer farm, is complete. Subsequent phases are currently underway and will be completed by the end of 2010.
PCT will achieve processing, manufacturing and development capabilities on completion of all the phases. Everything from the development of trial supplies to process development and commercial-scale production will be supported by the facility.
PCT facility production
The facility will develop cell-based therapeutic products, which are biological products developed from live human cells.
The products are used to treat a variety of diseases, including cell-based therapies for neurogenerative and other chronic diseases, vaccines for cancer and stem cells for regenerating tissues. By 2015, the stem cell market is expected to generate $2.5bn in revenues per year.
PCT is headquartered in Hackensack, New Jersey. The company was formed during the acquisition of HUMC's stem cell processing facility. Besides continuing with HUMC's stem cell transplant programme, the facility gradually began providing cell therapy-based services to other clients.
PCT develops cell-based products for almost every type of therapeutic areas, including diabetes, heart and muscle damage and degenerative diseases such as multiple sclerosis.