CDMO Profile Series: Inside the hive

Feb. 3, 2023
Northway Biotech has become a trusted CDMO partner — and helped build an international buzz for Lithuania

Vladas Bumelis has a sweet spot for bees.

Northway Biotech — founded by Bumelis in 2004 — boasts a lobby building with a cylindrical glass façade designed to resemble a beehive. Once inside the lobby, visitors are greeted by stylized bee sculptures and hexagonal honeycomb cell-shaped tiles. Employees who reach milestone anniversaries with the company are awarded glass bee statues.

“Bees are hardworking and highly collaborative creatures, working in a team with a clear organizational structure and well-defined roles that keep the nest healthy,” says Bumelis.

It’s that spirit that helped shape the core principles of Northway, a flexible biologics CDMO that Bumelis built from the ground up in Vilnius, Lithuania.

The homegrown company — which now has a sister site in the U.S. — offers fully integrated drug substance and drug product development as well as CGMP manufacturing services.

As the small but mighty country of Lithuania works toward an ambitious goal for its life sciences sector — 5% GDP contribution by 2030 — Northway Biotech continues to be a key producer in that quest. The industrious company has effectively tapped into Lithuania’s strengths to not only build a standout end-to-end CDMO, but also to put Lithuanian biotech on the map.

Building the hive

Bumelis, who serves as Northway’s chief executive officer and chairman of the board, is known around the Baltics to be a savvy biotech entrepreneur. And his litany of successful business launches throughout his 50-year career in life sciences certainly backs that reputation.

Bumelis’ decision to launch a CDMO in Lithuania came at a time when the country’s life sciences sector, after a temporary lull in the ‘90s following Lithuania’s independence from the Soviet Union, had only just started its accent. In fact, Northway was Lithuania’s first pharma CDMO.

“When I established the CDMO business, the area was relatively new. I decided to enter the market when it was accelerating to achieve competitive advantage over other key players,” says Bumelis.

His instinct was spot on. Close to 19 years later, Northway is thriving, and so is Lithuania’s life sciences sector, which is now among the fastest growing in Europe.

Northway Biotech, originally named Biotechpharma, initially focused on product development and small-scale GMP manufacturing, using a leased facility. But as customer projects advanced through pipelines and demand grew, Northway needed to expand its capabilities and its footprint.

Bumelis, ever the pioneer, chose a location in the then underdeveloped Santara Valley, in the northern end of the capital city of Vilnius. The Lithuanian government had approved five valley development programs back in 2008, with the goal of upgrading the country’s scientific research infrastructure — but Northway was one of the first companies to complete construction in Santara Valley. By 2011, the CDMO had its own R&D facilities, with reactors up to 10 liters in capacity. By the end of 2012, it was operating a new state-of-art GMP manufacturing plant.

Success continued and Northway invested in growth. In 2019, the company committed more than $56 million to a facility expansion, upping its fermentation capacity to 5,000 liters, and adding another process development laboratory.

“The first years, as standardly for new business, were a bit of a challenge as we had to prove that in Lithuania, we have excellent knowledge and can meet client needs. But soon after, we got a pace and are now counting over 90 clients from 24 different countries we have worked with,” says Bumelis.

The CDMO’s facilities in Vilnius now include 25 R&D labs as well as a CGMP manufacturing plant with both single-use and stainless steel systems for upstream and downstream processes. Northway distinguishes itself by offering CGMP drug substance manufacturing services based on both microbial fermentation technology and mammalian cell culture. In addition to drug substance manufacturing, Northway offers fill-finish of liquid and lyophilized drug product to provide its clients a ‘one-stop-shop’ solution.

Worker bees

A small country tucked away near the geographical center of Europe, Lithuania is quickly proving that it’s not to be overlooked when it comes to business. The country has one of the fastest growing economies in Europe. The life sciences sector in particular has expanded consistently, boasting a record average annual growth of 22% last year.

“While Lithuania is not necessarily the first location that comes to mind for biopharma outsourcing, our location offers considerable advantages to customers,” says Bumelis.

The biggest and most crucial advantage, according to Bumelis, is the country’s pool of highly skilled and motivated talent. “If you have a good bioreactor but no brains, you can’t do much,” he jokes.

Lithuania is home to six universities offering life science and biotech-related majors and has a solid base stemming from its rich scientific history, which dates back to an enzyme manufacturing factory and research center built in the early 1970s. The research center became the foundation for Lithuania’s Institute of Biotechnology and is now part of the Life Science Centre at Vilnius University.

“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,” says Bumelis.

According to Bumelis, almost all of Northway’s ~200 employees at the Vilnius site hold a minimum of a bachelor’s degree, with many having completed their master’s or doctoral studies.

But education alone isn’t what sets Northway’s staff apart. It’s the company’s ability — especially as a mid-sized CDMO — to ensure flexibility and speed.

“What makes Northway unique is the collaborative spirit with a creative approach to solutions we apply for every project. Sometimes projects may come with unexpected process challenges, and with quick adaptations, we help clients save time to meet clinical or commercial deadlines,” says Bumelis.

The track record of performance and high level of trust that Northway has established with its customers has resulted in frequent recommendations and a growing customer base. This, in turn, has helped build Lithuania’s reputation for delivering quality and reliability at a competitive price.

Staying busy

The buzz of activity has not slowed at Northway, even during the pandemic. Northway recently welcomed a new addition to the family — a sister site in the U.S.

The Waltham, Massachusetts-based site has been supporting local and international customer projects since summer 2020 in its process development labs. The company plans to open the doors to its 30,000-square-foot GMP facility in the first quarter of this year, hiring an additional 50 workers.

The new facility will provide end-to-end capabilities — from cell line development to drug product manufacturing — and is essentially a twin to the site in Vilnius.

“The equipment in both sites is 99% identical, allowing for seamless transfer or duplication of projects from one site to the other. This means that the same standard operating procedures and business process reengineering can be used at both locations,” says Bumelis.

This is a big benefit in the very global pharma market, enabling technology, processes and products to be seamlessly transferred between the U.S. and Europe, for approval in either location.

Key to Northway’s success has been the company’s ongoing willingness to reinvest and enhance its services and capabilities. In that spirit, Bumelis shared the company’s newest foray — gene therapy.

“I have purchased an area not far away from the existing facility in Vilnius, where I plan to build three advanced biotechnology centers,” says Bumelis.

One center will be dedicated to gene therapy product manufacturing, as well as R&D mainly focused on stem cell therapies and 3D bioprinting. The second and third sites will be mammalian and microbial production centers, respectively, with capacities to produce the material on a large scale, according to Bumelis.

Ultimately, Bumelis sees Northway Biotech as a single-source CDMO deeply invested in providing high quality, world-class services to customers around the globe.

And, just like the bees, he’s staying focused on the mission.

“Bees don’t fly for fun, they fly to deliver product,” says Bumelis with a smile. “The result of bees’ hard work is honey of the highest quality. It symbolizes the technologies we are giving to our customers.”

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'