Blue Bell, Pennsylvania, May 21, 2021 – IPS-Integrated Project Services, LLC, a leading provider of engineering, procurement, construction management, and validation (EPCMV) services, congratulates this year’s Facility of the Year Award (FOYA) winners from The International Society for Pharmaceutical Engineering (ISPE), including Locus Biosciences, Inc. and the Raymond G. Perelman Center for Cellular and Molecular Therapeutics. IPS provided commissioning, qualification, and validation (CQV) services for both organizations, detailed below.
“Being focused in life science, it gives us a sense of pride that all our projects enable our clients to bring life-impacting products or therapies to market,” states Dave Goswami, Chairman and CEO of IPS. “Supporting projects recognized with a FOYA adds further to our accomplishment and is particularly fulfilling and rewarding. Our CQV team successfully supported two of this year’s FOYA recipients, and we couldn’t be prouder of their efforts. To date, we have received recognition in 11 FOYAs, and I am humbled by the consistent award-winning solutions that our team of experts brings to our clients.”
Locus Biosciences, Inc. Commercial Phage Production Facility Upfit
CGMP CRISPR Facility CQV Services
The biotechnology startup company, Locus Biosciences (Locus), built a BSL-2 compliant, 12,000 square foot facility in a 30-year-old building to accommodate their increased production for future clinical trials. They are developing engineered bacteriophages to target specific unwanted bacteria in the body via the innovative antibacterial power of the CRISPR-Cas3 platform. ISPE FOYA committee recognizes Locus “for their need to build a facility that will produce safe and effective products.”
IPS’ CQV team helped Locus’ efforts by writing and executing the commissioning and qualification protocols for all seven utility, HVAC, and process support systems. Additionally, the team verified the specified architectural finishes for the entire facility and developed key documentation deliverables for the company.
Paul Garofolo, CEO and Co-founder of Locus, states, “We are thrilled to see our facility recognized for its state-of-the-art capabilities. IPS was incredibly helpful in our qualification efforts for the new site.”
Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT)
Clinical Vector Core, Research Lab, and Vivarium Lab CQV Services
The Clinical Vector of Core, a division of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) is located on the campus of the Children’s Hospital of Philadelphia’s (CHOP) and manufactures adeno-associated and lentiviral vectors for clinical trials. The judges felt that “the opportunity to merge cutting-edge medical treatment, integrated facilities, and technology in both an urban setting and close to the point of treatment were indicative of facilities of the future and the CCMT breaks the typical mold.”
IPS provided complete CQV services for this new cell and gene therapy manufacturing facility, including CQV program development, design reviews, risk assessments, and validation and data integrity services. Our CQV team commissioned and qualified over 120 pieces of equipment, including the facility itself, allowing more products to get to market at a rapid pace with lower risk and with the highest quality.
This project particularly appealed to the FOYA judges because of its impact on the future of cell and gene therapy facilities. With the industry’s growth projections, these smaller facilities are likely to be more typical, and the judges were particularly impressed with this submission’s integration to the campus, its synergy with the hospital, access to cutting-edge medicines, effective use of space, and the social and sustainability value it offers Philadelphia and those receiving treatment. The judges considered the CCMT was “more than a well-executed project. It represents strengths in integration, social impact, and the type of facilities we will see in the future.”
"'Knowledge, Skill & Passion' is not just our tagline, but something that truly motivates us to deliver world-class projects and services. I take pride in knowing that the work of our CQV team delivered throughout the world is supporting the important, lifesaving work of our clients." shares Vince Cebular, Sr. Vice President, Compliance of IPS.
About the ISPE Facility of the Year Awards Program
Established in 2004, the Facility of the Year Awards (FOYA) recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit ISPE.org/FOYA for more information.
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.
Sr. Compliance Consultant/Sr. Vice President Compliance
Dave Goswami, PE
Chairman & Chief Executive Officer
Anthony J. Relvas, LEED AP
PA Regional Manager, Compliance
Victor Singh, CxA, LEED AP
Sr. Director, CQV Operations