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Clinical Vector Core (CHOP)

Directors: van der Loo, Johannes., PhD; Zelenaia, Olga., PhD

Summary:

The Raymond G. Perelman Center for Cellular and Molecular Therapeutics at The Children's Hospital of Philadelphia has established a state-of-the-art cGMP clinical vector manufacturing suite for both adeno-associated viral vectors and Lenti viral vectors, help to realize the enormous promise of gene transfer therapy to address unmet medical needs.

The Core Facility utilizes a patented vector production technology and a highly efficient purification process that utilizes combined column and gradient centrifugation-based process steps. This system has manufactured clinical grade AAV vectors that have demonstrated excellent safety in several clinical studies.

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Services

  • Quality Control ( Support service )

    Quality Control:

    Bioburden/Sterility
    Bacteriostasis/Fungistasis
    Mycoplasma
    Endotoxin
    Replication Competent AAV
    Replication Competent LV
    Adventitious agents
    Other

  • Services ( Support service )

    Services:

    -- Manufacturing of clinical and non-clinical AAV and LV vectors per client specification
    -- Long-term stability (3, 4, 5 years) consistent with the duration of the Phase 1/2 study
    -- Device compatibility and short-term stability studies (as required)
    -- Manufacturing of clinical or non-clinical excipient
    -- Regulatory support for Investigational New Drug (IND) applications
    -- Letter of cross reference to our Drug Master File (DMF)


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Last updated: 2019-10-09T11:37:24.832-04:00

Copyright © 2016 by the President and Fellows of Harvard College
The eagle-i Consortium is supported by NIH Grant #5U24RR029825-02 / Copyright 2016