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Raymond G. Perelman Center for Cellular and Molecular Therapeutics
Projects

Clinical Vector Core, Research Lab, and Vivarium Lab CQV Services

Raymond G. Perelman Center for Cellular and Molecular Therapeutics, Philadelphia, Pennsylvania, United States

The Clinical Vector Core (CVC), a division of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics at the Children’s Hospital of Philadelphia (CHOP), is dedicated to the manufacturing of adeno-associated and lentiviral vectors supporting clinical trials and following current good manufacturing practices (CGMP) and manufacturing of GMP-process comparable vectors in support of pharmacology and toxicology preclinical studies.

CHOP is at the forefront of cell and gene therapies, and the consulting, commissioning, and qualification services IPS provided will keep them in the lead. IPS quickly commissioned and qualified over 120 pieces of equipment at a low cost, including the facility itself, allowing more products get to market at a rapid pace with lower risk and with the highest quality.

This new GMP facility is located in a lower-floor shell in CHOP’s Colket Translational Research Building that was specifically reserved for meeting the CVC’s growing backlog of pharmaceutical customers. The facility is a multisuite, multiproduct facility that includes a manufacturing area with ISO Class 7 and 8 (EU Grades B through D) cleanrooms, an area for quality control (QC), a laboratory for process development (PD), and support areas.

The new CVC GMP facility will double the amount of manufactured product and continue to positively impact the lives of hundreds of children with cancer.

This upgraded facility is 20 times the size of the previous lab space and will be the new home of about 30 CHOP scientists. It contains $31 million in state-of-the-art process equipment, lab equipment, and associated utilities – including centrifuge equipment, a vaporized hydrogen peroxide (VHP) decontamination chamber, airlocks, pass-through windows, particle monitoring systems, controlled environmental chambers, and a data acquisition system – all used to support the production of viral vectors.

The therapies developed through cell and gene therapy research have the potential to reach many other diseases beyond cancer. Research findings will also be used in identifying treatments for diseases ranging from cystic fibrosis to Parkinson’s. The implication of cell and gene therapy research for the future of medicine is enormous.

CHOP has joined forces with several pharmaceutical, research, and government health care organizations to develop cell and gene therapy and work towards eradicating cancer.

Client Name: Raymond G. Perelman Center for Cellular and Molecular Therapeutics
Region: AmericasCountry: United StatesOffice: Blue Bell, PA
Services: Commissioning, Commissioning, Qualification & Validation, CQV Program Development, Design Reviews and Risk Assessments, Quality Management Systems, Validation and Data Integrity ServicesIndustry: Cell and Gene TherapyFacility Type: Research & Development
Size: 13,000sfAward: 2021 ISPE Facility of the Year Award, Honorable Mention
Client Name: Raymond G. Perelman Center for Cellular and Molecular Therapeutics
Region: AmericasCountry: United StatesOffice: Blue Bell, PA
Services: Commissioning, Commissioning, Qualification & Validation, CQV Program Development, Design Reviews and Risk Assessments, Quality Management Systems, Validation and Data Integrity ServicesIndustry: Cell and Gene TherapyFacility Type: Research & Development
Size: 13,000sfAward: 2021 ISPE Facility of the Year Award, Honorable Mention

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