Clinical Vector Core Services

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The Clinical Vector Core (CVC) offers Good Laboratory Practices (GLP)-grade adeno-associated virus (AAV) and lentiviral (LV) vectors in addition to current Good Manufacturing Practices (cGMP)-grade viral vectors in support of early phase clinical trials. GLP-grade products are manufactured using a GMP-comparable process to support pre-clinical pharmacology and toxicology studies and early-phase clinical trials.

CVC Support Pre-Clinical Studies

The CVC offers the following services and quality control measures, refined over nearly two decades of vector manufacturing experience.

Services

  • Manufacturing for LV vectors and AAV vectors
  • AAV vectors include a variety of standard AAV serotypes, including AAV 1, 2, 5, 6, 8, and 9, as well as customer-defined custom serotypes (novel or modified serotypes may require a pilot run prior to scale-up)
  • Long-term stability testing services consistent with the duration of the Phase 1 and 2 study
  • Device compatibility and short-term stability studies
  • Research-grade products for proof-of-principle and bridging studies
  • Clinical products are manufactured in compliance with FDA cGMP regulations applicable to Phase 1 and 2 clinical trials
  • Manufacturing of GMP-grade and non-GMP grade AAV excipient
  • Regulatory and Chemistry, Manufacturing and Control (CMC) support for Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) applications
  • Letter of cross reference to our Drug Master Files
  • Other (please piecyks [at] chop.edu (contact us) for a full list of release assays)
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Quality Control

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