(GMP) Manufacturing for Viral Vectors & Vaccines

Across the Entire GMP Life Cycle

Our services comprise everything from the start of your viral vectors GMP life cycle. We start with the generation of your MCB and/or MVS, either from your cell line or vector platform or one of our established MCBs or vector platforms. With quality assurance and control integrated into the project team, we monitor and test the quality of your product every step of the way until the vial is ready for your (pre)clinical studies.

GMP Compliance

We generate efficient and optimized manufacturing processes. Our focus is on product and patient safety, which is why we adhere strictly to the prescribed GMP guidelines. To perpetuate the quality of our products we have a strict QMS in place. Annex 1 serves as a leading guideline, particularly with regard to the generation of sterile medicinal products.

Capability and Scale

Our newly built state-of-the-art clean room houses bioreactors up to 200L for the upstream process and numerous dead-end filtration, TFF, and chromatography devices for the downstream process, which is more than sufficient for your clinical studies. We could use either stable producer cell lines or transfection to produce your final product. Once the drug substance has been produced, we can manufacture your drug product in-house.

Drug Product Filling

At the end of the value chain, the drug substance is refined into a drug product. Our filling process is based on a semi-automated solution (robotic support) in a class A clean room environment to ensure aseptic conditions. We are capable of aseptically filling the drug product and required diluents into 2, 6- and 20-mL vials with a throughput of approx. 200-400 vials per hour. Our sterile production fulfills the necessary Annex 1 requirements.

State-of-the-Art Technologies

From upstream processing to downstream purification of your product with state-of-the-art, single-use systems for dead-end filtration, tangential flow filtration, or chromatographic purification and final aseptic filling, our aim is to always support our customers with cutting-edge technologies.

All in One Place

Our QC team is housed next to the GMP suite for efficient and fast measurements. Thus, short distances between our production facility and the quality control laboratories ensure optimal handling and analysis of sensitive viral products and intermediates.