The GMP for ATMPs conference has become a summer highlight over the past years, taking place each year in the mid of June. This year the conference came up with an innovative approach to account for the pandemic situation: a breath-taking eleven (11 !) hour talk series covering all chapters of the GMP for ATMPs guideline.
It was Rainer Gnibl, GMP/GDP Inspector from the Local Government of Upper Bavaria, a competent authority in Germany, who excelled in this rare kind of undertaking and recorded 11 hours of talks. The talk series as well as the following Q&A session provided an excellent insight into the guidance ruling the manufacture of ATMPs thanks to the experience of Mr. Gnibl. During the course of three days the participants could stream the talks chapter by chapter or do talk-hopping to watch those of most interest according to their current situation. The participants of the conference made active use of the possibility to submit questions that the panel answered in the final Q&A session. The panel consisted of Rainer Gnibl, Rüdiger Alt from Novartis who is a Manager Quality Assurance / Qualified Person for ATMP and Thomas Meindl and Stefan Gärtner from L+S Labor, both experts in alternative, rapid microbiological methods. Further panel members were Sabine Hauck from Leukocare and Andrea Hauser from University Regensburg, both representing the ECA's ATMP Interest Group. Axel Schroeder from Concept Heidelberg guided the panellists through the extensive Q&A session, eventually more than 60 questions were submitted.
Most of the questions related to ATMP in general, although CAR-T cells were a hot topic accounting for about a third of the questions. Further products of interest were mRNA products and autologous cell therapies. Since investigational ATMPs account for a fair amount of ATMP activities, several questions addressed this early development phase. The participants showed broad interest in all chapters of the guideline, whereby most questions related to production and QC, followed by QP-release. The hotly debated new Annex 1 was addressed as well as other focus topics on e.g., Brexit, stability studies, raw material quality, QA system and risk assessment. In an extended 2.5 hour Q&A session, Rainer Gnibl provided response by guideline references and pointed out the respective guideline section, while the other panellists contributed their working experience. Again a successful conference that provided an innovative, home-office friendly approach to familiarize the participants with this rather new guideline. We are looking forward to next year's event on GMP for ATMPs to meet our valued participants again - hopefully in person!
To get more information about the activities please visit ECA's ATMP Interest Group at the group website.
If you missed the event, there is also the possibility to order the recording.