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.

Creation and design of website

All details regarding the creation of the website are available via the following link:

The information published on this site is the property of the Naobios.
Such information may not be reproduced, in full or in part, without the consent of the Naobios. Users are responsible for the searches they make and for the interpretation and use they make of the results. It is their responsibility to use the information in compliance with the regulations in force and the recommendations of the CNIL (the French data protection authority) when the data concerned is of a personal nature.
In particular, they should be aware that the information may only be used for strictly personal use, and that taking screenshots to recreate or expand a database containing people's personal details is against the law in France and is therefore forbidden. Similarly, it is also forbidden to use screenshots for commercial or advertising purposes.

Personal Data

In accordance with Act No. 2004-801 of 6 August 2004 on the protection of individuals in relation to the processing of personal data, amending Act No. 78-17 of 6 January 1978, this website has been registered with the CNIL [French data protection authority]. Terms of the Laws (available on the CNIL website: www.cnil.fr) Act No. 78-17 of 6 January 1978 on Data Processing, Data Files and Individual Liberties, known as the Data Protection Act; CNIL Decision No. 81-94 of 21 July 1981 adopting a recommendation on the general security measures for computer systems; Act No. 88-19 of 5 January 1988 on computer fraud, referred to as the Godfrain Act.

Links

Any third parties wishing to create hyperlinks to pages or documents available on this website, which could in fact constitute an infringement of copyright, or an act of free riding or libelling, must first obtain the authorisation of the Naobios. Requests for such authorisation may be made directly to the site administrator.
Said authorisation will be granted as long as the links do not harm the interests of the Naobios, and as long as they guarantee that the user will be able to identify the document as originating from the Naobios, particularly where deep linking, framing or insertion by links is used.
Similarly, the Naobios has sought permission in writing from all the servers indicated, to create links to its site: the information remains fully the property of these servers and the Company cannot be held liable for it in any way.

CREDITS

All content (photos, texts, video, sound, etc.) available on this website remains the exclusive property of the Naobios and/or its partners, and is protected by French legislation on copyright and intellectual property. All rights of reproduction are reserved, including for downloadable documents and illustrations and photographs.

It is forbidden to extract and/or reproduce a substantial part of the information published on the site without the prior consent of the Naobios.

Any attempt to do so constitutes an infringement punishable under Articles L.335-2 et seq. of the French Intellectual Property Code.

The Intellectual Property Code states that it is necessary to quote the source of the information or request the permission of the author of the images. It applies only within the framework of compliance with copyright law. As a creation of the mind, images (even screenshots) are thus protected by copyright (Article L.112-2-9 of the French Intellectual Property Code).

Reproducing or representing images, text or documents without permission is punishable under civil law by an order to pay damages. Such damages are determined on a case by case basis. It depends on the victim's loss of earnings, the damage suffered as a result of the misrepresentation of the way the website was presented and the impact that may have had on the author of the site. It depends also on the way the image was put forward and on what it might have brought the designer in financial terms.

Photo credits : Naobios - Fotolia