Lithuania is a small country in the Baltic region of northeastern Europe bordering the southeastern shore of the Baltic Sea. While largely a service economy, Lithuania, which is a member of the European Union, has a substantial industrial sector that produces chemical products, plastics, machinery and appliances. Biotechpharma UAB, a rapidly growing contract development and manufacturing organization located in Vilnius, is adding biologic drug substances and drug products to the list of goods exported throughout Europe, North America, Asia and the Middle East.
Biotechpharma was founded in 2004 as a contract development and manufacturing organization (CDMO) providing support for branded biologics and biosimilars. Initially, the company rented space for its product development and small-scale GMP manufacturing activities. As customer projects advanced from early to late phase, we received a growing number of requests to expand our capabilities.
In response, we inaugurated our own R&D facilities with reactors up to 10L in capacity in 2011. By the end of 2012, we were operating in a new state-of-the art GMP manufacturing plant. The investments required for these two new sites were approximately €12 million and €30 million, respectively. In 2014, a top-ten pharmaceutical company became a key customer, bringing a number of different development projects to Biotechpharma; since then we have attracted customers from around the world.
The growing demand for manufacturing of monoclonal antibodies and mammalian-cell derived products led to the need for additional capacity. In 2017, a 2000L mammalian single-use line including a seed train consisting of 10L, 50L and 500L bioreactors became operational. A cGMP pilot plant was also completed in 2017 for the production of both microbial and mammalian products to meet growing demand for small-scale GMP production of material for initial preclinical and clinical studies, and the installation of a new 3000L microbial fermentation line is currently underway.
Integrated, Full-Service Biologics CDMO
Biotechpharma is a fully integrated CDMO with the ability to satisfy all customer needs, from gene sequencing to final product manufacturing. We can perform cloning/cell-line development for both bacterial and mammalian processes, execute efficient upstream and downstream process development and optimization and provide GMP manufacturing of clinical and commercial drug substances and formulated products packaged in vials and syringes.
Flexible and Responsive
As a midsized CDMO, Biotechpharma is able to provide flexibility and responsiveness backed by a strong foundation in science and technology. We focus on understanding our customers and meeting their specific needs without binding them to one single approach. We are able to react rapidly to unexpected project changes, adjusting timelines, capacities and other activities to meet their evolving needs. We have on average 25–30 development projects underway each year, covering gene cloning to final drug product manufacturing.
Lithuania for Biotechnology
Lithuania is a small country that is generally not well known to many in the biopharmaceutical industry. It has proven for Biotechpharma, though, to be a good location. Initially, it took some effort to prove that Biotechpharma is great at biologic drug development and manufacturing. One visit to our site, however, was typically all that was needed to allay any concerns. Today, the track record of performance and high level of trust we have since established with our customers results in frequent recommendations. Our commitment to our customers is also reflected in our ongoing willingness to reinvest in the company.
While we serve customers located around the world, we do anticipate ultimately expanding Biotechpharma’s physical footprint outside of Lithuania. Northway is a separate holding company located in California that may serve as a basis for the acquisition of process development companies in the region. U.S. customers would then be able to access our process development capabilities more easily, with internal technology transfer to the manufacturing plant in Lithuania as their projects progress.