Overview and Capabilities of Naobios

Naobios provides bioprocess development and contract manufacturing services for viral vaccines and viral vectors. The company was acquired by Clean Cells on March 1st, 2019 and now supports clients for process development and the manufacture of preclinical and clinical batches.

Facilities and capabilities

Naobios is located in Saint Herblain (France) and is composed of independent biomanufacturing and R&D areas. The biomanufacturing and QC areas operate according to European GMP. The company has the capacity and expertise to handle complete projects for process development and GMP manufacturing of cell banks, virus seeds and clinical batches of Drug Substance. Extensive use is made of Single-use-Systems (SUS) to improve efficiency, minimize cleaning and avoid cross contamination. The production clean rooms can accommodate Single-use Bioreactors up to 250 litres, together with an homogenizer, TFF systems, Single-use filtration and chromatography systems for DSP operations.

Activities

The QC unit handles environmental monitoring and in-house testing for raw materials, media, buffers and intermediates as well as Drug Substance. Methods development and validation and stability studies are also handled. Some activities are outsourced, including specific testing of raw materials, intermediates and Drug Substance for microbiology, detection of adventitious agents and sequencing. Most outsourced biosafety testing activity is performed by 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 aspects of the requirements necessary to operate a GMP facility are covered.

Qualified Team

The Naobios team is dedicated to process development and manufacturing. Teams are cross functional and run projects which are managed by our experienced management team allowing careful tracking of our programs. The Naobios team has significant experience in the utilization of suspension or adherent cells for the production of viral vaccines or viral vectors and in the development of scalable production processes and GMP manufacturing.

Services

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

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