We offer a broad range of pre-clinical and clinical manufacturing services for recombinant proteins.
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 recombinant proteins. In this facility, we also frequently manufacture GMP-grade master and working cell banks. 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 Batavia Biosciences 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, i.e. a cross-functional team comprising 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.
Our comprehensive expertise on cell culture, purification, product analysis and characterization allows us to deliver a complete package of purified product together with associated biochemical and analytical characterization data. We have successfully delivered biosimilar enzymes, growth factors, fertility hormones, clotting factors, antibodies, antibody fragments, viral proteins and antigens for R&D purposes. We have performed many protein and antibody projects for large pharmaceutical companies, biotechnology companies and non-profit organizations with superb customer satisfaction.