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1rem

The collaboration will leverage Thermo Fisher’s Accelerator Drug Development stable of solutions, which was launched in the fall of 2024.

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The epinephrine nasal spray was approved for the emergency treatment of type 1 allergic reactions in adults and children.

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Biologics on Target for the Future

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Pharm Tech Group looks at the challenges surrounding the development and manufacture of ATMPs in more detail with Agne Vaitkeviciene, CEO of Memel Biotech.

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.

 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.

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Within the highly regulated pharma industry, adoption of new technologies is generally slower than in other industries, as such, despite three-dimensional (3D) printing being available for some time now, its use in the production of medicines is still very much a novelty. However, 3D printing technology has a great potential within the pharma industry, particularly for personalized medicines.

FABRX, a small start-up company that was created by academics from the University College London in the United Kingdom, is focused on the use of 3D technologies in the future of medicine. At CPHI Barcelona 2023, 

 spoke with Carlos Rial Calvo, lead software engineer of FABRX AI—a subsidiary of FABRX based in Spain and started in 2023—to learn more.

“Our aim is to personalize medicine for patients,” explained Rial Calvo. “This is very useful, for example, for highly potent drugs that require very specific dosing.” Additionally, using 3D printing technology to personalize medicine is very useful for pediatrics, who can find swallowing medication difficult, so, Rial Calvo pointed out that it is possible to produce medication that is easier for children to adhere to.

Similarly, for patients that need to take multiple tablets, Rial Calvo noted that with the 3D technology it is possible to create polypills—a combination of different APIs in one printlet (3D printed tablet). “We create polypills, and then [the] patient only has to take one tablet,” he said.

FABRX is currently collaborating with hospitals across Europe, Rial Calvo specified. “For example, we are running a clinical trial in an [oncology] hospital in France to combine an anti-cancer drug with a drug for the side effects [of the cancer treatment] into the same pill,” he stated (1).

In another clinical study, the company has worked with the University of Santiago de Compostela and the University Hospital in Santiago de Compostela in Spain to develop a 3D printed medicine for a rare disease, Rial Calvo revealed. For this study, FABRX prepared doses of isoleucine for children with maple syrup urine disease—an inherited metabolic disorder (2). Using the 3D printing technology, flexible production of a personalized dosage form was possible.

“We provide the software for controlling the machines, but also the software provides features to help with the development of new formulations,” Rial Calvo concluded. “So, the researchers can use our software as well, with the machine, to test new materials.”

1. FABRX. FabRx and Gustave Roussy Enter into an Agreement to Develop a Novel, Personalised, Multi-Drug Dosage Form for the Treatment of Patients with Early-Stage Breast Cancer. 

, Press Release, June 25, 2021.
2. FABRX. FabRx Performs the First Clinical Study Using Personalised 3D Printed Dosage Forms to Treat Children with a Rare Metabolic Disease. 

Fabrx was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Carlos Rial Calvo from FABRX, a pharmaceutical 3D printing company, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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3D Printing Medicines with FABRX at CPHI Barcelona

Specialty Dosage Drugs

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