Process development customized to your product’s requirements and supported by an experienced team
Partial of full process development to generate GMP-ready processes
Naobios proposes services to sponsors to support the partial or full development of the bioprocesses involved in the manufacture of viral-based products (vaccines, vectors and oncolytic viruses).
This can be performed through the de novo design of processes or through the optimization of an existing process. This also includes up-scaling capabilities to generate a GMP-ready process that can be transferred internally or back to the sponsor.
Our versatile team works in both Process Development and GMP laboratories and has a strong record, handling a large range of products.
It is supported by the JMP software which facilitates design of experiments and by the analytical team which can develop and validate bespoke methods.
Development at all stages of the manufacturing operations (USP and DSP)
Process development can be proposed for the following intermediates or intermediates:
- Cell banks
- Virus Banks
- Drug Substances: inactivated or live viral vaccines, viral vectors, Oncolytic virus)
The development laboratories are constituted from five independent BSL2 suites allowing activities on different projects in parallel.
Upstream processing (USP) and downstream processing (DSP) are concerned by the development activities.