{"id":652,"date":"2024-10-09T12:37:34","date_gmt":"2024-10-09T10:37:34","guid":{"rendered":"https:\/\/www.darqa.org\/?p=652"},"modified":"2026-08-11T12:55:51","modified_gmt":"2026-08-11T10:55:51","slug":"report-gmp-atmps-what-makes-them-different","status":"publish","type":"post","link":"https:\/\/www.darqa.org\/index.php\/language\/en\/2024\/10\/09\/report-gmp-atmps-what-makes-them-different\/","title":{"rendered":"Report on GMP ATMPs: What Makes Them Different?"},"content":{"rendered":"

Event language:<\/strong> This event was held in Dutch.<\/p>\n

This was DARQA’s first event dedicated to Advanced Therapy Medicinal Products (ATMPs). Speakers joined us not only from the Netherlands, but also from the United Kingdom and Sweden. Contributions from all DARQA committees gave the day a genuinely cross-GxP perspective.<\/p>\n

Hans de Koning ensured that the day ran smoothly and that everyone had an opportunity to ask questions.<\/p>\n

Christine Mitchell (ChrisalisQAdvice) gave a general introduction to ATMPs and their classification. She also shared practical tips on seeking advice from the EMA and finding general information on its website. She highlighted the need for risk assessment and a robust strategy throughout the drug-development pathway to avoid surprises and additional work later: \u201cBegin with the end in mind\u201d (Stephen Covey<\/em>).<\/p>\n

Ion Tcacencu (Venn Life Sciences) gave an interesting presentation on the preclinical aspects. He likewise emphasised the need for a risk-based strategy and explained that specific animal disease models may be required. Although safety studies should be conducted according to Good Laboratory Practice, he noted that some products had received marketing authorisation even though not all studies had been performed at a GLP-compliant test facility.<\/p>\n

Flow cytometry is often used both to characterise ATMPs and to assess samples collected from participants during clinical trials. Marie Geerlings (Ardena) gave a very clear overview of how flow cytometry works and offered valuable tips for auditing this type of analysis.<\/p>\n

Thilo Buck (Progress Experts in Life Sciences) concluded the morning with a presentation entitled Good Manufacturing Practices and Beyond: Essential Regulatory Insights for ATMPs<\/em>. Although specific GMP guidance exists for ATMPs, some grey areas remain, including how Annex 1 should be applied. He gave the audience an excellent overview of the different regulations that need to be considered.<\/p>\n

After lunch, we continued with the theme of manufacturing. Marc Kamp (Kite Pharma) presented real-life situations involving both ATMP manufacturing and the associated logistics and transport. These can be highly complex because ATMPs often involve personalised medicines and transport across the globe. It is essential to keep manufacturing time to an absolute minimum so that the treatment can be returned to the patient promptly.<\/p>\n

<\/p>\n

Katie Brock (Kite Pharma) continued with a session on clinical studies and ATMPs. She discussed the need for additional approvals, such as GMO approval, and explained that ATMP trials often require a tissue establishment licence. Many parties are involved, both internally and at the study site. Training internal staff, clinical staff and CRO clinical research associates in the use of ATMPs and the applicable GCP requirements is therefore important.<\/p>\n

Finally, Eveline Krijger (Acerta Pharma), our new DARQA chair, presented several quality challenges relating to quality management systems, monitoring and auditing in ATMP clinical trials. One example was how to select high-risk sites for investigator-site audits when the investigational medicinal product is administered only once and the recruitment period is short.<\/p>\n

The day concluded with a lively question-and-answer session involving all speakers. We are all still learning about ATMPs and how our established ways of working may need to change. The more we know and understand about these products, the faster we can develop these exciting new medicines for the people who need them most. We hope DARQA will continue to follow the ATMP journey in the future.<\/p>\n

DARQA members can download the presentations from the DARQA website.<\/p>\n

Author:<\/strong> Christine Mitchell, DARQA GLP Committee member<\/p>\n","protected":false},"excerpt":{"rendered":"

DARQA\u2019s first day dedicated to ATMPs explored preclinical development, flow cytometry, GMP, manufacturing, logistics, clinical studies and the quality challenges surrounding these innovative medicines.<\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[68],"tags":[],"class_list":["post-652","post","type-post","status-publish","format-standard","hentry","category-uncategorised-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/posts\/652","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/comments?post=652"}],"version-history":[{"count":1,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/posts\/652\/revisions"}],"predecessor-version":[{"id":671,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/posts\/652\/revisions\/671"}],"wp:attachment":[{"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/media?parent=652"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/categories?post=652"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.darqa.org\/index.php\/wp-json\/wp\/v2\/tags?post=652"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}