PCT Expanding Allendale NJ Facility To Enhance Global Operations
Poskanzer Skott Architects Designs EU- and FDA-Compliant Clean Room Expansion and Upgrades
ALLENDALE/RIDGEWOOD, N.J., Sept. 28, 2016 – Poskanzer Skott Architects (PSA) of Ridgewood, NJ has designed an expansion for Allendale, NJ-based PCT, a Caladrius Company. PCT is a leading development and manufacturing company that focuses exclusively on the cell therapy industry. The design, which includes additional clean rooms and other upgrades, will improve PCT’s capability to provide commercial grade cGMP manufacturing capacity, and most importantly, meet compliance requirements for product distribution into the European Union.
“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,” explains 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 FDA norms and five which are compliant with requirements set by the European Medicines Agency (EMEA). PCT expects construction on the latest expansion to be completed in 2017.
“We take great pride in the quality and longevity of our relationship with PCT,” explains 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. They offer cGMP (Current Good Manufacturing Practices) infrastructure for the manufacturing of cell-therapy based products including: quality systems, streamlined technology, transfer, storage, logistics, cell and tissue processing.
An established, award-winning design and planning firm, Poskanzer Skott is recognized for its innovative and practical solutions to architectural challenges. The company has broad experience in the entire design process from concept to completion working on behalf of office, industrial, retail, multi-family, educational, health care and residential real estate clients, including the public, private and non-profit sectors.
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About Poskanzer Skott Architects
Follow Poskanzer Skott Architects on Facebook and LinkedIn
About PCT, a Caladrius Company
PCT, a Caladrius Company (PCT), a subsidiary of Caladrius Biosciences, Inc., is a leading contract development and manufacturing organization in the cellular therapy industry that works with clients to achieve commercial-readiness for their products. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. For more than 17 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing cell therapy and immunotherapy product candidates from the development stage all the way through to commercialization. PCT offers manufacturing of cell therapy products, engineering and innovation services, process and analytical development, cell and tissue processing, collection and storage, consulting, facility design, validation, and due diligence evaluations. These services enable clients to focus on quality, cost of goods, scalability, and sustainability as key mile markers as they think beyond regulatory approval.
About PCT, a Caladrius Company
PCT, a Caladrius Company (PCT), a subsidiary of Caladrius Biosciences, Inc., is a leading contract development and manufacturing organization in the cellular therapy industry that works with clients to achieve commercial-readiness for their products. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. For more than 17 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing cell therapy and immunotherapy product candidates from the development stage all the way through to commercialization. PCT offers manufacturing of cell therapy products, engineering and innovation services, process and analytical development, cell and tissue processing, collection and storage, consulting, facility design, validation, and due diligence evaluations. These services enable clients to focus on quality, cost of goods, scalability, and sustainability as key mile markers as they think beyond regulatory approval.
ALLENDALE/RIDGEWOOD, N.J., Sept. 28, 2016 – Poskanzer Skott Architects (PSA) of Ridgewood, NJ has designed an expansion for Allendale, NJ-based PCT, a Caladrius Company. PCT is a leading development and manufacturing company that focuses exclusively on the cell therapy industry. The design, which includes additional clean rooms and other upgrades, will improve PCT’s capability to provide commercial grade cGMP manufacturing capacity, and most importantly, meet compliance requirements for product distribution into the European Union.
“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,” explains 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 FDA norms and five which are compliant with requirements set by the European Medicines Agency (EMEA). PCT expects construction on the latest expansion to be completed in 2017.
“We take great pride in the quality and longevity of our relationship with PCT,” explains 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. They offer cGMP (Current Good Manufacturing Practices) infrastructure for the manufacturing of cell-therapy based products including: quality systems, streamlined technology, transfer, storage, logistics, cell and tissue processing.
An established, award-winning design and planning firm, Poskanzer Skott is recognized for its innovative and practical solutions to architectural challenges. The company has broad experience in the entire design process from concept to completion working on behalf of office, industrial, retail, multi-family, educational, health care and residential real estate clients, including the public, private and non-profit sectors.
###
About Poskanzer Skott Architects
Follow Poskanzer Skott Architects on Facebook and LinkedIn
About PCT, a Caladrius Company
PCT, a Caladrius Company (PCT), a subsidiary of Caladrius Biosciences, Inc., is a leading contract development and manufacturing organization in the cellular therapy industry that works with clients to achieve commercial-readiness for their products. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. For more than 17 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing cell therapy and immunotherapy product candidates from the development stage all the way through to commercialization. PCT offers manufacturing of cell therapy products, engineering and innovation services, process and analytical development, cell and tissue processing, collection and storage, consulting, facility design, validation, and due diligence evaluations. These services enable clients to focus on quality, cost of goods, scalability, and sustainability as key mile markers as they think beyond regulatory approval.
About PCT, a Caladrius Company
PCT, a Caladrius Company (PCT), a subsidiary of Caladrius Biosciences, Inc., is a leading contract development and manufacturing organization in the cellular therapy industry that works with clients to achieve commercial-readiness for their products. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. For more than 17 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing cell therapy and immunotherapy product candidates from the development stage all the way through to commercialization. PCT offers manufacturing of cell therapy products, engineering and innovation services, process and analytical development, cell and tissue processing, collection and storage, consulting, facility design, validation, and due diligence evaluations. These services enable clients to focus on quality, cost of goods, scalability, and sustainability as key mile markers as they think beyond regulatory approval.