Cell & Gene Therapy Services

With our integrated services, we can support our clients developing viral vectors (mainly AAV and LV), during all stages of drug development.

Our highly experienced process development (PD) team, can adapt our HEK293 suspension based AAV manufacturing platform, to our client’s needs, or develop a unique cGMP ready manufacturing process, based on our client’s production cell line and vectors. In our PD laboratories, we can run single-use bioreactors lab scale and up to larger scales at pilot scale. Our corresponding downstream equipment supports both process development and material supply, for formulation development with our trusted strategic partners or pre-clinical studies.

Key analytical methods to support process development and optimisation are already available as platform methods. In addition, our analytical development team will custom develop the methods required by our client and then transfer these either to our QC department or qualified partner CROs for qualification/validation and release testing.

A phase appropriate formulation is critical to the success of a clinical program, and we offer you best-in-class services for viral vector formulation via our trusted strategic partners.

We can provide non-GMP toxicology material from our pilot plant in PD or produce up to tox batches from a combined Tox/ER run in our dedicated viral vector cGMP suite. Here, we also produce bulk drug substance using fully single-use equipment and a mainly closed process.

Drug product manufacturing and drug product release testing and stability is offered in collaboration with our trusted strategic partner network.