HiTech Health are delighted to have attended the 3rd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress on 16th and 17th May. HiTech Health’s Quality and Compliance Lead Julie-Anne O’Neill and Manager of Cell and Gene Therapy Operations Aoife Duffy presented at this in-person event and shared experiences in navigating the quality, regulatory and manufacturing challenges of ATMPs.
On day 1, Julie-Anne talked about ATMP manufacturing and regulatory challenges from a QP’s perspective, including considerations for; materials and supplier control, manufacturing complexities, sterility assurance, release strategy and regulatory, training and personnel, traceability of ATMPs, stability; and concessionary release. ATMPs are complex products and risks may differ according to the type of product, nature or characteristics of the starting materials as well as the level of complexity of the manufacturing process. This presents a number of unique challenges to ATMP development and manufacturing that Julie-Anne talked about on the day.
It is important to have a QP experienced in ATMPs involved as early as possible in the development process to ensure quality and compliance standards are met. You can find out more about our QP services here.
On day 2, Aoife presented how to create and establish an ATMP infrastructure and what is needed to build a robust supply chain for cell and gene therapies. Aoife talked about key considerations for building the right capabilities and systems to ensure patients receive the vital therapies. During the presentation, Aoife announced that during the early stage of the Covid-19 pandemic, HiTech Health established a laboratory in County Galway, providing process and analytical development services. The company now has two R&D laboratories operating and offers a growing range of services in the ATMP space. The next expansion phase, adding GMP clean rooms, is almost completed and will include manufacturing services for clinical trial materials.
We would like to thank Global Engage for organising this exciting event as well as the attendees who engaged with this year’s Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress in Dublin.