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.
The above diagram represents AAV platform that we adopt in process development and cGMP. Below is a an explanation how we implement this platform in cGMP.
Cell expansion in shake flasks is performed in a fully separate room in a BSC qualified to grade A. Here cells are expanded to 2 L shake flask scale before transfer to the production room. Using fully closed aseptic connections cells are expanded into rocking bed (Wave) and later stir tank bioreactors (XDR) for transfection and virus production – currently at a larger scale.
In our platform, we use detergent-based lysis and DNase treatment, followed by multi-layer filtration (up to 0.2µm) to clarify the harvest. Hollow fibre-based concentration/diafiltration and different ready-to-use chromatography steps, further concentrate and purify the product until the final concentration, buffer exchange and filtration step of the bulk drug substance into container for storage and shipment.
Tailor Made Solutions
We treat your projects as if they were our own and deliver what we promise. We work with each of our clients on a tailormade approach to develop a strategy that best addresses their unique needs.
Expert Know How and Support
We leverage the expertise and experience of our highly qualified team, drawing on decades of specialization in cell and gene therapy production.
Backed by Extensive CMC Experience
We are backed by Rentschler Biopharma’s 50 years of experience and unwavering reputation in the development and manufacturing of biopharmaceuticals for both clinical and commercial supply.