Viral vector manufacturing

We offer a broad range of preclinical and clinical manufacturing services for viral vector products.

We operate BSL-2 R&D and GMP manufacturing facilities. The GMP facility is equipped to run up to 200 L mammalian cell line-based processes and is fully licensed to manufacture viral vectors. In our facility, we also manufacture GMP-grade master and working cell banks and master and working virus seeds. Overseeing quality is a Qualified Person (QP), Quality Control (QC) department and Quality Assurance (QA) department.

We appoint a dedicated project manager to each project, be it a pre-clinical or clinical manufacturing project. The project manager is usually already familiar with the project, having been involved in the quotation writing process. The project manager acts as the “eyes and ears” of the customer, ensuring that the organization delivers on promises. These are defined in deliverables, so that overall milestones are met in time and according to budget. Hereto, the project manager is tasked with building the project team. This cross-functional team comprises all contributing functional departments required for the execution of the project.

The project manager serves as the central point of contact for the customer in all project-related matters. During the project, frequent meetings between the customer and project manager are scheduled. During these meetings, the project manager informs the customer on progress, deliverables met, challenges, delays, hurdles and should it be required, proposes potential solutions to mitigate any deviations from the set timelines.

Viral vector manufacturing track record

We have performed more than 50 viral vector projects for large pharmaceutical companies, biotechnology companies and non-profit organizations with superb customer satisfaction.

Preclinical manufacturing

Your preclinical research is only valuable if your data can be reproduced. This requires the use of high quality and well-characterized research materials.

Clinical manufacturing

We offer a broad range of clinical manufacturing services for replication-competent or non-replicating viral vectors.

Product release and regulatory support

We offer expert manufacturing and regulatory support in translating processes into regulatory dossiers.

Upstream process development
Downstream process development
Product release and regulatory support

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