10th of November 2023
Transferring novel therapies succesfully to patients and market
10th of November 2023
ATMPs (advanced therapy medicinal products) are considered as the drugs of the future. Research and development are being driven forward worldwide. Germany and the EU are not at the forefront! 85% of the currently ongoing clinical trials for ATMP development and market launch take place in the USA and China.
In the EU, there are extensive regulatory requirements for the manufacturing and testing of ATMPs for use in clinical trials (iATMPs). This drives up investment and manufacturing costs. Lack of know-how in facility design as well as uncertainties in the implementation of "Good Manufacturing Practice" (GMP) requirements, pharmaceutical quality assurance system, clean rooms, equipment and especially process development for GMP-compliant manufacturing of iATMPs add to this. As a result, there is a lack of production facilities and capacities in Europe; a stumbling block that must be seen as a negative location condition.
With the "cult.tainer®", a Valicare brand, we offer you an exclusive service solution in the form of a complete concept for your GMP-compliant development and production of iATMPs. We equip GMP-compliant clean room modules specifically for your process, plan and install your state-of-the-art production facility, and guide you to the start of production under a legal manufacturing authorization within 12-18 months.
Fig. 1: cul.tainer® as a "stand-alone unit.
The clean room production modules can be adapted at any time to different cell and gene therapy products (not only CAR-T cells) and to starting materials (vectors, cell banks, plasmid DNA, etc.) and everything can also be combined. The capacity of the facility ranges from clinical phases I-III to early market supply, depending on the product.
Our cult.tainer® concept also means that Syntegon and Valicare experts advise, accompany and support you along the entire value chain from development to production. We offer service packages for the entire process or separately for individual phases only
If you want to treat patients with your ATMP in the foreseeable future and later to the market, we recommend that you plan the entire process early but at least during preclinical development. The only way to ensure a smooth transfer to GMP-compliant manufacturing.
Our cult.tainer® concept offers the ideal solution for this!
Fig. 2: Timelines and service packages from development to manufacturing approval and start of production.