ECA Academy is an educational organization focused on GMP and regulatory compliance. This year’s ECA e-conference will give a holistic overview of the current regulatory landscape for the development, manufacture and approval of Advanced Therapy Medicinal Products (ATMP). Regulatory, QC, production and consultant experts will give an insight into their practical experiences.
During this e-conference Antleron CEO Jan Schrooten will discuss how implementing an innovative process development strategy can positively impact ATMP quality, safety, scaling and regulatory compliance.
The lecture, entitled Cell by Design®, a Quality-Focused Process Development Roadmap for ATMP, will focus on the quality by design (QbD) methodology as an innovative solution for end-to-end ATMP process development. By employing QbD from the very beginning of the ATMP development process, quality is put first and desired outcomes can be reached faster and more effectively.
Co-developed with Quality by Design, Cell by Design® is a cloud-based software that facilitates (personalized) ATMP process development from lab to patient. This risk-based methodology allows researchers, process engineers and manufacturers to take control of material and process variability and ensure a high-quality end-product through a robust and regulatory compliant bioprocess.