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GMP Manifacturing of Investigational Medicinal Products

advent

Advent, is a joint-venture between IRBM and Okairos (acquired by GSK in 2013). The Advent GMP facility, directed by Prof. Riccardo Cortese, complies with the regulatory guidelines of FDA and EMEA, with the objective to maximize quality and cost effectiveness. Advent is producing investigational medicinal products, including the Okairos Ebola vaccine. The company collaborates with industry and public institutions such as the NIH and the University of New York.

Advent can provide a series of services as an intergrated package or as stand-alone service, including the following processes:

  • Construction, rescue and production of research grade recombinant Adenoviral vectors
  • Preclinical process development and scale-up
  • Analytical development and validation
  • GMP manifacturing for gene products
  • GMP quality control
  • QP release
  • Quality assurance and regulatory affairs