Robotics and automation offer groundbreaking manufacturing methods for ATMPs.
ATMPs are achieving groundbreaking success in the treatment of previously incurable diseases. The number of approved ATMPs has risen steadily over the last five years and will reach a new high in 2024. However, development and production are relatively expensive and complex.
ATMPs are sensitive and time-critical and should be prepared close to the patient. However, the patient population to be treated is small and not centralized. Therefore, technological, economic and geographic considerations must be made to drive the commercialization of these innovative therapies. The usual commercial distribution model in its current form is not suitable for this. New, forward-looking manufacturing processes for ATMPs need to be created that are flexible, agile and multimodal.
Automation and Robotics for ATMPs
ATMPs require specially tailored processes. They are produced in small batches, which are sensitive and have a short service life. In addition, maximum throughput is required during production as the starting material is limited. Targeted small-batch production in isolated automated manufacturing systems offers the decisive advantage here.
Precise, highly repeatable and adaptable automation in a filling and finishing environment is a suitable tool to meet the key process and regulatory points for ATMP production. From a process perspective, automation significantly reduces the burden on the filling and capping process by eliminating unnecessary human intervention. When it comes to product safety and integrity and consistently meeting the stringent requirements of the CCS, comprehensive, intelligent automation in an isolated environment is clearly the first choice.
Operating with an Isolator
Adaptive robotics, automation and isolator barrier systems provide parenteral manufacturers with proven methods to meet the specific requirements of their ATMPs and optimally produce safe and effective therapies.
Valicare supports you with your ATMP production
Are you planning to manufacture an ATMP to supply your clinical trial? Do you have any questions or need support with the realization of your ATMP production?
We can support you with solutions specially tailored to your manufacturing process.
We would like to recommend the cult.tainer® concept. It is a self-sufficient, turnkey solution, especially for ATMP production, which accelerates the experienced time to the first successfully produced batch.
