Memel Biotech to Offer ATMP Manufacturing at Lithuania Site

Editor's note: this story was originally published on BioPharmInternational.com.

Memel Biotech, a Lithuania-based contract development and manufacturing organization, announced on April 4, 2024 that it has launched a fully integrated advanced therapy development and manufacturing service at its facility in Klaipeda, Lithuania, which will serve markets in the European Union (EU). With this new service, the company aims to target partnerships with emerging and established biotech companies seeking to enter the advanced therapy medicinal product (ATMP) space. The company will operate a new good manufacturing practice (GMP) facility, where it will offer discovery-to-delivery service for all three classes of ATMPs: cell therapy, gene therapy, and tissue-engineered therapy.

Memel has built its technical expertise in product formulation, process and analytical development, process scale-up and automation, GMP manufacturing, validation, and logistics. The company has also maintained up-to-date knowledge of regulatory approval demands and processes in key markets, according to a company press release. The company’s manufacturing range encompasses mesenchymal stem cells, induced pluripotent stem cells, extracellular vesicles, immune cells (including natural killer cells and dendritic cells), and gene modified cells, including chimeric antigen receptor T cells.

“Advanced therapies have enormous potential to make life changing impacts on patients, but there is no escaping the fact that they are complex and challenging to manufacture and deliver,” said Agnė Vaitkevičienė, CEO, Memel, in the press release. “Based on our previous experience in the sector, we believe Memel has the portfolio of services and skills to meet the challenges companies that are aiming to make a difference face—from initial formulation to scale-up—whilst conforming to the still emerging regulatory framework. In addition to European clients, our location also offers an ideal EU entry point to [the] US [United States] and ROW [rest of world] companies.”

Lithuania will soon house the largest biotech city under a project to be launched by the Northway Group, a collection of 17 enterprises within the fields of medicine, healthcare, biotechnical formation, and investment operations. In November 2023, the group announced its plans to build BIO CITY, expected to be the largest biotechnology hub in Europe and home to six large biotechnological complexes. Four of the complexes will be state-of-the-art GMP plants, and two will be scientific research centers. With a total area equivalent to the size of 10 football fields, BIO CITY is expected to cost €7 billion (US$7.6 billion) over the next decade (1).

According to Olga Potapova, president of the Cureline Group, a US-based company that provides management of scientific and pre-clinical research, development of diagnostic products, and organization of biological and tissue testing, “Memel is a natural extension of the [Cureline] Group’s portfolio. We have closely followed the development of the advanced therapies sector over the last decade in particular. Rather than try to repurpose any existing CDMO we believe the time is right to create a truly specialized partner who can take an active role in helping customers achieve their missions to bring these exciting new treatments to patients. Lithuania, with its highly skilled workforce, supportive environment, stability, and EU membership, is also an ideal location.”

Reference

1. Northway Biotech. The Largest Biotech City in Europe Will Soon Be Built by Northway Healthcare Group, with an Investment Amounting to 7 Billion Euros. Press Release, Nov. 16, 2023.

Source: Memel Biotech