Overview and Capabilities of Naobios

Naobios provides bioprocess development and contract manufacturing services for viral vaccines and viral vectors production. The company has been acquired by Clean Cells on March 1st, 2019 and operates since then as a CMO with the mission to support clients for process development and manufacture of preclinical and clinical batches in the most efficient way.

Facilities and capabilities

Naobios facility located in Saint Herblain (France) consists of biomanufacturing and R&D area. The manufacturing area and QC laboratories operate according to GMPs. The unit has the capacity and expertise to handle complete projects for process development and GMP manufacturing of cell banks, virus seed and clinical batches of Drug Substances. The production clean rooms can accommodate single-use bioreactors up to 250 liters, together with homogenizer, TFF systems, single-use filtration and chromatography systems for DSP operations. Extensive use is made of Single-Use-Systems (SUS) to improve efficiency, minimize cleaning and avoid cross contamination.

Activities

The QC unit is independent to production and handles environmental monitoring, in-house testing for raw material, media and buffers, intermediates and Drug Substance, method development and validation as well as stability studies. Some activities are outsourced, including specific testing on raw materials, specific testing on intermediate and Drug Substance such as microbiology, detection of adventitious agents, sequencing. Most of biosafety testing is outsourced to Clean-Cells.

www.clean-cells.com

Quality Assurance

The facility is managed and operated according to a strict Quality Management System, ensuring compliance, manufacturing support, validation and documentation management controlled by the Quality Assurance group. All the aspects of the requirements necessary to operate a GMP facility are covered.

Qualified Team

Naobios team is dedicated to process development and manufacturing. Groups are cross functional to run projects which are managed by project management allowing tracking all the aspects of the programs. The team is an experienced group in the utilization of suspension or adherent cells for production of viral vaccines or viral vectors and in the development of scalable production process and GMP manufacturing.

Services

  • Cells banks
  • Viral seed stocks
  • Process and analytical method development
  • GMP production of vaccines, viral vectors and oncolytic virus
  • Lot release and stability testing
  • CMC services

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