Articles Tagged with: ISPE

Gene Therapy Cleanroom Facility Wins International Award

The Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) Clinical Vector Core at the Children’s Hospital of Philadelphia (CHOP) was recognized as a model for the future by the International Society for Pharmaceutical Engineering​ (ISPE) in their 2021 Facility of the Year Awards program.

The Clinical Vector Core (CVC), a state-of-the-art cleanroom facility dedicated to manufacturing adeno-associated and lentiviral vectors, provides viral vectors in support of Phase I and Phase II clinical gene therapy trials in compliance with current Good Manufacturing Practices (cGMP), as well as GMP-process comparable vectors in support of pharmacology/ toxicology pre-clinical studies. Ballinger served as architect and engineer for the project.

The judging panel selected CCMT because of its impact on the future of cell and gene therapy facilities, noting 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.

“Working in collaboration with architects and engineers since 2015, we developed a state-of-the-art GMP manufacturing facility that will help support the growing field of gene therapy not only locally, but nationally and internationally,” said Johannes C. M. van der Loo, PhD, director of the Clinical Vector Core at CCMT. Over the past 17 years, the Clinical Vector Core has manufactured close to 150 clinical grade products for 40 different indications. Vectors have been used in 27 clinical trials in 10 countries.

Ballinger Associate Principal Joshua S. Levy, AIA, LEED AP, who served as Project Architect for the CVC, described the space as “a machine that prioritizes the human experience without compromise to the facility’s stringent operational and performance requirements.”

The project, recognized by the jury as a model for the future, did not fall within one of ISPE’s award categories and was therefore recognized with Honorable Mention. Established in 2004, the Facility of the Year Awards program recognizes the best pharmaceutical and biotechnology manufacturing facilities globally and highlights projects that utilize new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. It provides a platform for the pharmaceutical science and manufacturing industry to showcase accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches.

Read more about the Clinical Vector Core

Ballinger Presents at ISPE Facilities of the Future Conference

Experts from Ballinger, Children’s Hospital of Philadelphia and IPS gave a presentation at the ISPE 2020 Facilities of the Future Conference. Their talk “Manufacturing Cell and Gene Therapies within the Academic Medical Center Environment” explored the road to a fully validated drug development facility and how architecture and engineering can support the translational research continuum from bench to bedside.

Ballinger Principal Dennis Potter, PE, LEED AP joined Johannes van der Loo, PhD of Children’s Hospital of Philadelphia (CHOP) and Anthony Relvas of IPS to share a case study of a new 15,000 SF cGMP facility on CHOP’s West Philadelphia campus. The presentation covered early planning stages through design, construction, commissioning and qualification, with a focus on how a fully integrated team developed a space that is helping to realize the enormous promise of gene transfer therapy to address unmet medical needs.

The mission of the International Society for Pharmaceutical Engineering (ISPE) is to connect pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence and regulatory insights. Their annual Facilities of the Future Conference, held this year in San Francisco, brings together professionals involved in all facets of the pharmaceutical manufacturing lifecycle.