Finding a More Optimal Way for ATMPs (BIO 2024)

Advanced therapy medicinal products (ATMPs) are a promising class of therapeutics that can provide useful treatment options for a wide variety of diseases. However, the development and manufacture of these advanced therapeutics is complex and challenging.

“The ATMP field is developing relatively slow,” explains Agne Vaitkeviciene, CEO of Memel Biotech, a Lithuanian-based specialized contract development and manufacturing organization. Development of ATMPs is hindered by factors such as the cost of the final product or the cost of manufacture, she specifies. One way to overcome such challenges, is “to find a more optimal way for manufacturing using innovative technologies using innovative solutions,” Vaitkeviciene adds.

However, manufacturing capacity and general expertise around ATMPs are also being discussed as potential hurdles to the advancement of these promising therapies. “I think the general capacity for biomanufacturing, not just ATMPs, is already an issue, especially in Europe; a lot of manufacturing was relocated somewhere else,” Vaitkeviciene says. Yet, a lot of the ATMP manufacturing is now returning to Europe and the United States, she continues, explaining that there has also been a push from policymakers to increase capacity.

“There has been a lot of [action to improve ATMP capacity] to catch up with the capacity manufacturing needs,” Vaitkeviciene notes. “And I think it will, [capacity] will catch up [with demand], I don't think it will go into a critical or crisis stage, I'm positive in that.”

Watch the video for the full interview. Memel Biotech will be exhibiting at the 2024 BIO International Convention in San Diego, Calif., from June 3–6.

Agne Vaitkeviciene holds a BS in Molecular Biology (Vilnius University, Lithuania) and an MS in organ, tissue, and cell donation for Cell Therapy (University of Barcelona, Spain). Since 2006, she has been working in the field of cell therapy and ATMP manufacturing under GMP conditions. In 2013 Agne Vaitkeviciene co-founded a life science startup company and managed its activities in the field of advanced therapy medicinal product (ATMP) research and manufacturing as CEO until 2019. Since 2019, she has been actively involved as an expert in EU programs, such as IMI2, EIT Health Innostarts, and consults biotechnology companies in life science product development management. For the past five years, Agne has been actively involved in life science expert groups within Lithuanian governmental organizations such as the Innovation Agency of Lithuania and Invest Lithuania. Association LithuaniaBIO elected Ms. Vaitkeviciene as a Vice-President in 2019 and delegated her responsibilities of coordinating foreign affairs and startup support activities within the Association. In 2020–2023, she was the Executive Director of LithuaniaBIO. In 2020, Agne joined Cureline Group as a COO of Cureline Baltic and later, together with Dr. Olga Potapova, founded Memel Biotech in 2021 in Klaipeda, Lithuania. Currently, Agne is responsible for overall Cureline Group activities in Lithuania, provides leadership for the ATMP CDMO program, and coordinates BD efforts in the EU region for member companies of the Cureline Group.