DSP (DownStream Processing)
Downstream bioprocess development, process optimization and scaling-up activities
Naobios is supported by an expert team and a multipurpose facility composed of five independent units (BSL2 and BSL3) allowing for full bioprocess development operations, from Upstream Processing to Downstream Processing. Our experience covers the development of processes for the following products:
- Vaccines: inactivated vaccines, live attenuated viral vaccines;
- Viral vectors;
- Oncolytic viruses.
To achieve high efficiency, our teams can rely on both Experiment Design (DOE) and dedicated staff members skilled in analytical development that supports the assessment of key parameters defined to ensure the purity of the final product.
Naobios benefits from a highly-qualified team working specifically on the Downstream Processing part of your process. The DSP development group focuses on achieving the product specifications and quality attributes set by the client, optimizing and defining the critical process parameters for harvest clarification, virus concentration, elimination of process related impurities, and to achieve highest virus recovery yields.
To develop your process and ensure its scalability, specific assessments on screening and selection of resins, filters or membranes are established and follow a development plan built in collaboration with your team. We thus ensure that the resulting flow of processes if directly transferable to the GMP manufacturing group inhouse.
Naobios, as a GMP-certified pharmaceutical company, is indeed an expert in GMP biomanufacturing of Investigational Medicinal Products (IMP, also known as Investigational New Drugs – IND) and is aware of the technical, scientific and regulatory expectations of such manufacturing programs.
High-end equipments are in place to ensure flexibility in the performance of your process.
These technologies allow for the typical sequences of DSP, such as virus purification, virus inactivation or DNAse treatment.
The DSP development can be done from small scale using the following systems:
- TFF systems,
- Filtration Systems,
- Chromatography systems (AKTA Explorer, Pilot & Pure).