Speed and Customized Support from Gene to GMP Manufacturing

Emerging, small and mid-sized biopharma companies with limited resources need contract development and manufacturing partners that can offer personalized support. By combining a range of integrated services supporting biologics throughout the life cycle, with the benefits of an expert, young and dynamic workforce, Biotechpharma UAB is uniquely positioned to support biopharma companies across the globe.

Biologics Continue to Dominate

Biologics are typically more expensive to develop than small molecule drugs, but they offer significant benefits to patients and are, on average, 40% more profitable to manufacturers.1 Biologics dominate the current slate of blockbuster drugs, including four of the five best-selling therapies (Humira, Eylea, Rituxan, Enbreal). The appeal of developing the next blockbuster is echoed by the drive to develop biosimilar therapies, with as much as $100 billion in revenue open to competition by 2020 as patents expire.2 Additionally, biologics development is driven by the increasing importance of orphan drugs, with sales projected to reach $262 billion by 2024, accounting for 20% of the prescription drug market.3 With the importance of biologic drugs increasing annually, the number of biotech startups is exploding, particularly in the United States, and the number of biotech IPOs offered on U.S. exchanges peaked in 2018.4 Many of these emerging and small businesses have limited resources and lack the capacity and capabilities to carry their projects through the necessary development phases. CDMOs that offer customized services designed specifically to support smaller firms can help them rapidly progress their projects from the R&D stage to first-in-human trials. The global market for biologics outsourcing is expected to undergo double-digit compound annual growth rates to reach $70.3 billion by 2025.1

Integrated CDMO Services in Demand

Biotechpharma is a full-service CDMO located in Vilnius, Lithuania with capabilities in cell line development, process development and optimization, and mid-size volume GMP manufacturing of biologic drug substances and drug products. We provide support for the development and production of branded biologics and biosimilars and are committed to achieving rapid project advancement by providing the highest-quality customized services that are needed by smaller biopharma companies and increasingly sought by large pharma.

We support our clients worldwide and can deliver projects at any stage, from cell line construction and process development through fill/finish of cGMP biopharmaceutical products. We 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.

We are actively seeking to develop partnerships with U.S.-based biopharma companies that need support from development through clinical material manufacturing and commercial supply. We hope to expand partnerships with companies that value the tailored support we can offer.

The Lithuania Advantage

While Lithuania is not necessarily the first location that comes to mind for biopharma outsourcing, our location offers considerable advantages to customers. We have a proven track record of delivering the quality and reliability that they require at a competitive price. Owing to our country’s state-subsidized public university system — including the venerable and prestigious Vilnius University — we are able to draw from a pool of highly scientifically and technically educated and trained talent. Almost all of the staff at Biotechpharma hold a minimum of a bachelor’s degree, with many having completed their masters or doctoral studies. Most have worked in the biotech industry for at least five years, and many have decades of experience spread across small and large pharmaceutical companies located around the world. Our staff has extensive knowledge and understanding of the expectations of regulatory agencies in the EU, United States and Asia. High quality and on-time performance are ensured by a team of experienced researchers and management professionals, while Vilnius is just a two-hour flight from major European hubs, including Frankfurt and London, has full EU member status and uses the Euro as its currency.

Focused on Speed and Flexibility

As a mid-sized CDMO, Biotechpharma provides flexibility and responsiveness, backed by a strong foundation in science and technology. We focus on understanding our customers without binding them to a single approach. We are able to react rapidly to changes in project requirements, adjusting timelines, capacities and other activities. We do not simply provide a timeslot and capacity, but work as partners with our customers to provide customized support from development to commercialization.

Our Chairman of the Board, Vladas Bumelis, a four-decade veteran of the biotech industry and recipient of the Award of Lithuania in 2004 for his work developing some of the first recombinant proteins, characterized our ability to support the scope of customer needs as follows: “Biotechpharma is poised to become a global leader among mid-sized CDMOs for developing and producing recombinant proteins, because our strong integration allows us to do everything that biotech companies need — cloning genes in bacteria and mammalian cells, developing upstream and downstream processes and analytical methods, scaling up, and GMP production.”

We support our clients worldwide and can deliver projects at any stage, from cell line construction and process development through fill/finish of cGMP biopharmaceutical products.

Expanding Capabilities

With expectations of growing demand for our upstream and downstream process development and optimization, and GMP clinical/commercial drug substance and formulated product manufacturing services, Biotechpharma is continuing to invest in greater capacities and capabilities. 

We are looking to expand our capacity by adding a new plant at our Vilnius site. Flexible facility design will also allow for increased mammalian cell culture production capacities in addition to the two existing production lines up to 1000-L and 2000-L, all equipped with single-use bioreactors. 

Our Chief Business Officer Frank Ternes, who brings 30 years of experience in big pharma and CDMO organizations, explains how this expansion supports our strategic goals: “We are better positioned than ever to meet the growing global demand for these specialized capabilities — and to become a fully integrated biopharmaceutical CDMO.”

Separately, we will soon be implementing an initiative focused on the development of platform technologies and knowledge for the production of biologic drug substances. With platform technologies in hand, we will be able to further streamline our operations and reduce project timelines for our clients — initial results are expected in 2020. 

References

  1. $70.3 Billion Biologics Outsourcing Markets, 2025. Markets Insider. 18 Aug. 2017. Web.
  2. “Key biologics patents expiring in 2020.” Manufacturing Chemist. 14 Mar. 2017. Web.
  3. World Preview 2018, Outlook to 2024. Rep. EvaluatePharma. Jun. 2018. Web.
  4. Booth, Bruce. “Biotech IPO Markets: Closing The Books On 2018’s Crazy Year.” Forbes. 3 Jan. 2019. Web.

Giedrius Žunda

Mr. Žunda has more than 16 years of experience with Sicor Biotech UAB, a leading biotech company in Central and Eastern Europe, and Teva Pharmaceutical Industries Ltd, the largest generic company in the world, where he steadily advanced within the organization. Under his leadership, the Vilnius site completed FDA inspections and commercialized products in both the EU and U.S. Most recently, he served as Site General Manager of Biologics Plant and member of the Board at Sicor Biotech UAB, Teva’s Lithuanian subsidiary. Mr. G. Žunda earned a Master’s degree from Vilnius Gediminas Technical University.