ALLENDALE, NJ—Allendale, NJ-based PCT, a cell therapy development and manufacturing company, is expanding its facilities to include additional clean rooms and other upgrades, to improve the firm's ability to provide meet compliance requirements for product distribution into the European Union.
Poskanzer Skott Architects, based in nearby Ridgewood, NJ, designed the expansion facilities for PCT.
“The expanded design provides additional space to house growing demand for our services, including expanding our capability to process, manufacture and develop EU-compliant cell therapy products,” says Robert A. Preti, PhD, president and co-founder of PCT. “We thank PSA for their past and ongoing support to grow PCT's infrastructure alongside the advancement of the cell therapy industry.”
PSA designed the original Allendale facility in 2008, with plans to build out in phases. Phase One included four clean room suites and a freezer farm unit with multiple liquid nitrogen freezers. PSA subsequently designed two additional clean rooms which were done in 2016. Recently completed stages of the work include redesigned warehouse and storage space with plans to move and upgrade bathrooms and locker rooms. The two additional clean rooms included in this new design will bring the facility up to a total of eight which are fully compliant with Food and Drug Administration norms and five which are compliant with requirements set by the European Medicines Agency. PCT expects construction on the latest expansion to be completed in 2017. The standards, known as Current Good Manufacturing Practices, or CGMPs, provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
“We take great pride in the quality and longevity of our relationship with PCT,” says partner Barry Poszkanzer, AIA. “PCT is an exciting company and we look forward to providing additional support and services as the company expands, and as compliance regulations require.”
PCT is the only GMP-compliant cell therapy external manufacturing partner with two facilities located on both east and west coasts of the United States. Its CGMP infrastructure for the manufacturing of cell-therapy based products including: quality systems, streamlined technology, transfer, storage, logistics, cell and tissue processing.
ALLENDALE, NJ—Allendale, NJ-based PCT, a cell therapy development and manufacturing company, is expanding its facilities to include additional clean rooms and other upgrades, to improve the firm's ability to provide meet compliance requirements for product distribution into the European Union.
Poskanzer Skott Architects, based in nearby Ridgewood, NJ, designed the expansion facilities for PCT.
“The expanded design provides additional space to house growing demand for our services, including expanding our capability to process, manufacture and develop EU-compliant cell therapy products,” says Robert A. Preti, PhD, president and co-founder of PCT. “We thank PSA for their past and ongoing support to grow PCT's infrastructure alongside the advancement of the cell therapy industry.”
PSA designed the original Allendale facility in 2008, with plans to build out in phases. Phase One included four clean room suites and a freezer farm unit with multiple liquid nitrogen freezers. PSA subsequently designed two additional clean rooms which were done in 2016. Recently completed stages of the work include redesigned warehouse and storage space with plans to move and upgrade bathrooms and locker rooms. The two additional clean rooms included in this new design will bring the facility up to a total of eight which are fully compliant with Food and Drug Administration norms and five which are compliant with requirements set by the European Medicines Agency. PCT expects construction on the latest expansion to be completed in 2017. The standards, known as Current Good Manufacturing Practices, or CGMPs, provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
“We take great pride in the quality and longevity of our relationship with PCT,” says partner Barry Poszkanzer, AIA. “PCT is an exciting company and we look forward to providing additional support and services as the company expands, and as compliance regulations require.”
PCT is the only GMP-compliant cell therapy external manufacturing partner with two facilities located on both east and west coasts of the United States. Its CGMP infrastructure for the manufacturing of cell-therapy based products including: quality systems, streamlined technology, transfer, storage, logistics, cell and tissue processing.
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