Memel Biotech Launches Advanced Therapy Contract Development And Manufacturing Organization At The New EU Gateway In Lithuania.

• Agile and comprehensive development and manufacturing partnerships for all three advanced therapy classes – cell, gene and tissue engineered
• Strategically located offering gateway to Northern and Central Europe
• Good Manufacturing Practice (GMP) facility and a state-of-the-art supporting the manufacture of stem cells, tissue engineered products, exosomes and immunotherapeutics
• Extended range of services from discovery and formulation through preclinical and development stages to late stage clinical and commercial production, including fill and finish and logistics
• Expert regulatory strategy and support for EMA, FDA and national approvals
• Experienced team and backed by resources of US Cureline Group

Memel Biotech today announced it has launched a fully integrated advanced therapy development and manufacturing service from its state-of-art facility strategically located for EU markets at the Baltic seaport of Klaipeda, Lithuania.

Memel will target partnerships with both emerging and established biotech companies looking to enter the advanced therapy space. Operating from a new GMP facility, Memel will offer a seamless discovery-to-delivery service for all three classes of advanced therapies – cell, gene and tissue engineered.

Over the past two decades, the Memel team has gathered a wealth of technical experience in product formulation, process and analytical development, process scale-up and automation, GMP manufacturing, validation and logistics. This is complemented by up-to-date knowhow of regulatory approval demands and processes in all key markets.

Memel’s manufacturing range includes Mesenchymal Stem Cells (MSCs), Induced Pluripotent Stem Cells (iPSCs), Extracellular Vesicles (EVs), Immune cells (NK, DC) and gene modified cells, including CAR-T cells.

CEO Agnė Vaitkevičienė, a leading light in the development of the European advanced therapy sector serving as an expert adviser to the EU, explains the reasoning behind Memel’s foundation: “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. 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 US and ROW companies.”

Cureline Group President Olga Potapova adds: “Memel is a natural extension of the 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.”