In The News

Genesis Receives Facility of the Year Award for Cellular and Molecular Therapeutics Project

By: Karen

The ISPE Facility of the Year Awards (FOYA) recognized the Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) at the Children’s Hospital of Philadelphia (CHOP) with an Honorable Mention. The facility was praised for its innovative design and pioneering role in the future of cell and gene therapy facilities. This award, given in the Operational Agility category, highlighted Genesis AEC for its role in the facility’s development.

Established in 2005, the CCMT is dedicated to leading research into gene therapy disease. With a mission to bridge the gap from “bench to bedside”, the facility embodies an integrated model for healthcare facilities of the future, combining cutting-edge medical treatment, state-of-the-art facilities, and advanced technology.

Situated within CHOP, the nation’s first hospital dedicated to child care, the CCMT offers a 13,000-square-foot Good Manufacturing Practice (GMP) facility. It’s designed for the production of adeno-associated and lentiviral vectors supporting clinical trials, which are key components in gene and cell therapies. Its location not only allows for the rapid translation of research into treatment, but also situates the facility in a context that fosters empathy and motivation through daily interaction with the patients its research seeks to help.

Despite the spatial challenges posed by renovating an existing building, the CCMT effectively manages cross-contamination risks typical of a multi-product/process/trial facility through individual suite decontamination, achieved with a mobile VHP system integrated into the ventilation controls.

The CCMT’s design optimizes the use of space and creates a working environment designed for comfort and efficiency, which includes features like high ceilings, lines of sight, and windows. This unique combination of functional, employee-friendly design and advanced cleanroom technology supports a diverse team of engineers, chemists, and biologists who are passionate about developing treatments for rare or ultra-rare diseases.

Genesis AEC, as the Programming and Process partner, played a crucial role in developing this pioneering facility. The company’s expert guidance and collaboration helped bring to life a model that both leverages the smaller scale of cell and gene therapy treatments and prioritizes patient needs. In addition, Genesis’ role contributed to the seamless integration of the CCMT into the existing campus and hospital structure, thus improving resilience, cost-effectiveness, and reuse of existing space.

Ultimately, the FOYA judges were impressed by the CCMT’s integration into the campus, its synergy with the hospital, access to cutting-edge medicines, effective use of space, and the social and sustainability value it brings to Philadelphia and those receiving treatment. The CCMT facility offers vision and embodies an outcome that the judges felt deserved recognition. The facility has already completed multiple clinical trials, demonstrating a successful outcome of the project.

In summary, the Raymond G. Perelman Center for Cellular and Molecular Therapeutics, with the essential support of Genesis AEC, represents a paradigm shift in medical facility design and functionality. This FOYA recognition marks it as a leader in the cell and gene therapy industry, emphasizing its social impact, integration, and envisioning the future of healthcare facilities.

Glossary:

  1. Good Manufacturing Practice (GMP) facility: A facility that manufactures products (in this case, adeno-associated and lentiviral vectors for clinical trials) according to quality standards defined by regulatory agencies to ensure their identity, strength, quality, and purity.
  2. Adeno-associated and Lentiviral vectors: Tools commonly used in biological research and therapy for delivering genetic material into cells (gene therapy).
  3. Mobile VHP system: A mobile Vaporized Hydrogen Peroxide system used for sterilizing and decontaminating areas within a facility, such as laboratories or production areas.

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About Genesis AEC

Genesis AEC – an award-winning consulting, architecture, engineering, and construction management firm – has partnered with life sciences companies for more than 25 years to complement the scientific expertise of our clients as they usher in the next generation of life-saving therapies, treatments, and technologies. Whether it’s providing AE support for existing sites; commissioning, validation, and qualification (CQV) for specific processes or equipment; or turnkey design-build solutions, our team blends sound science and technical expertise with quality assurance and safety measures to deliver unparalleled results.