NorthX Biologics is a pioneering Swedish contract development and manufacturing organization (CDMO) that combines deep-rooted scientific heritage with cutting-edge biotechnological advancements. Headquartered in Matfors with an additional facility in Stockholm, NorthX specializes in a wide range of biologics modalities, including proteins, nucleic acids, and viral vectors. The company’s Innovation Hub plays a central role in supporting the development of both traditional and advanced therapies, a vital testing ground for new programs and approaches. With a commitment to sustainability and community involvement, NorthX leverages proprietary technologies and development and manufacturing experience to provide services that go beyond the typical CDMO, pioneering novel approaches for both large and small clients. In this Q&A, Chief Executive Officer Janet Hoogstraate, Ph.D., discusses the strategic initiatives helping the company to comprehensively address the evolving needs of the biopharmaceutical sector, in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.
David Alvaro (DA): To begin, can you share the story of the origins of NorthX Biologics and the foundational vision driving the company?
Janet Hoogstraate (JH): NorthX Biologics was officially established in October 2021, although the facilities and its people have long been operational under different entities and leadership dating back to 1963. Our founding vision was to create a state-of-the-art facility here in Matfors, Sweden, with advanced capabilities for biologics, including proteins, RNA, and cell therapies, primarily aimed at empowering R&D projects and innovative therapies where manufacturing might not yet be established. This focus is crucial, especially for smaller biotechs and even larger companies where not every project can be accommodated.
We have been able to leverage the legacy experience and expertise of sites and teams from our predecessor companies, like Cobra Biologics, to deliver on this new vision. The acquisition of the Stockholm-based Clinical Trial Manufacturing unit from Valneva last year not only expanded the geographical footprint but also enhanced our technical expertise and capabilities, particularly in mammalian expression systems and viral vectors. This combination of heritage, innovation, and modern capabilities continues to shape NorthX's unique culture and strength.
DA: What are the values that define NorthX Biologics and the company’s culture?
JH: At NorthX, we say, "We are small enough to care; big enough to deliver." Although this is a borrowed phrase, it captures our core very well. True values must be demonstrated consistently by an organization, not merely stated. For us, caring is central, and that care manifests in our focus on customer relationships and partnerships, which are built to last and are foundational to our operations.
Innovation is also an important pillar. Our Innovation Hub was truly central to the inception of NorthX, and that dedication to innovation cascades from there across all of our operations.
Our long-standing site in Matfors is not just a workplace; it's a community deeply rooted in the traditions of rural Sweden. This setting has shaped a strong culture of collaboration, where team dynamics and a collective ability to overcome challenges are key to our success. Our employees embody a tight-knit spirit that enhances our processes and drives continuous growth and development.
This emphasis on teamwork and community is integral not only locally but across all our interactions, playing a crucial role in successfully delivering projects. As we expand in Sweden and beyond, we continue to diversify our team. Successfully integrating a range of cultural backgrounds has enriched our company culture and bolstered our global operations. Our leadership team, with its diverse experiences from various industries, significantly contributes to our strategic and operational approaches, strengthening our internal capabilities and enhancing our position in the global market.
Reliability and experience underpin our ability to deliver on promises, ensuring that our partners can depend on us for both small-scale and large-scale projects.
DA: Are there any additional values or priorities you have personally brought to the company since your appointment as CEO last summer?
JH: I firmly believe in fostering a culture of accountability within the team. It’s crucial for me that team members feel empowered to make decisions independently while knowing they have my full support. This approach encourages a proactive rather than reactive decision-making process throughout the organization. I also strive to instill enthusiasm and engagement among our team members. Being genuinely engaged in what we do and helping each other succeed are fundamental principles I champion, and they drive the collective success and fulfillment of our roles.
DA: How are your core capabilities and services structured, and to what extent do you see them evolving in the near future?
JH: We describe our service as providing complete solutions. Whether it's a large pharmaceutical company or a biotech startup with a groundbreaking idea needing clinical development, they may lack the necessary manufacturing expertise or capacity. That's where we come in, offering a full CMC package that includes process and analytical development, manufacturing, quality control, quality assurance, and qualified person services.
We approach our services by dividing them into two main areas — microbial and mammalian work — each requiring specific expertise with some overlap. From there, we branch into various modalities like plasmids, mRNA, proteins, viral vectors, and cell therapies, but they all begin with the specific capabilities and expertise needed at the microbial and mammalian levels.
Looking forward, we are keenly observing the industry's evolution. Our Chief Technology Officer Ola Tuvesson and his team stay actively engaged through collaborations, literature, and conferences to gauge emerging trends. Our goal is to evolve alongside our customers, ensuring that we are equipped with the right technologies to support their needs and ambitions, often before they even articulate them. This proactive approach allows us to adapt and potentially prioritize new modalities that align with market developments and client demands.
DA: What can you share about recent and forthcoming acquisitions and your overall growth strategy looking forward?
JH: Last year’s acquisition primarily aimed to enhance our mammalian capabilities, which were more developed at our Stockholm site compared with our headquarters in Matfors. This has significantly broadened our technical scope. Internally, we recognize that our technical capacity can be expanded by adding both personnel and new projects, so there is considerable potential for organic growth within our existing operations.
However, we are always looking for strategic acquisitions or partnerships that can extend our service offerings. When a new technology emerges that aligns with our customers' needs, we evaluate whether to develop this capability in-house or through a company that brings the desired expertise and cultural fit. This proactive approach to potential acquisitions is a continuous focus for us.
Regionally, while we are rooted in Sweden and have traditionally served Nordic countries, we are actively expanding our presence in Europe and are increasingly looking toward the U.S. market. We have already established some key partnerships there and are committed to establishing a stronger customer base in the United States.
DA: Can you elaborate on the role of the Innovation Hub and its central role at NorthX?
JH: The Innovation Hub at NorthX is central to both our identity and strategy, not merely enabling early projects but providing state-of-the-art infrastructure for both non-GMP and GMP manufacturing. This includes cutting-edge techniques like mRNA manufacturing, allowing us to support innovative academic or biotech projects without the need for heavy investment in expertise or facilities. For example, we established an mRNA line in anticipation of its growing importance in modern therapies well before we had a specific project lined up.
The hub’s flexibility and responsiveness allow us to tailor our capabilities to customer needs swiftly, avoiding the typical delays of setting up complex equipment like reactors. It’s designed to quickly advance ideas from concept to next-phase development, offering researchers and startups the opportunity to work directly with our labs to move their projects forward and identify bottlenecks early on .
Moreover, our Innovation Hub serves as a testing ground for new technologies that may later integrate into our broader CDMO services. This includes proprietary technologies, such as our plasmids and our work with outer membrane vesicles.
This dual role of the Innovation Hub — supporting external innovation while enhancing our internal capabilities — ensures that we stay at the forefront of biotechnology, continuously integrating successful innovations into our manufacturing practices. It’s supported by Vinnova, Sweden's innovation agency, which helps us stay connected to national and European research and funding networks, further enhancing our capacity to innovate. Through these efforts, we aim to offer complete solutions to clients of all sizes, helping them bring innovative therapies to patients. This is what drives us every day at NorthX.
DA: Are you working toward a specialized focus in one or more of your capabilities or aiming to remain remaining flexible to change in order to meet various customer needs and market demands?
JH: At NorthX, we operate within the advanced biologics sector, focusing primarily on GMP standards, although we also engage in non-GMP processes as steps toward concept testing and clinical manufacturing. Our capabilities encompass preclinical, clinical, and commercial manufacturing, enabling NorthX to support our clients throughout the entire development process. We clearly emphasize versatility and adaptability in our offerings. For instance, if a particular modality doesn't see expected demand or market interest within a couple of years, we’re prepared to shift our focus. Our approach is to balance market demands with anticipated trends, ensuring that we can swiftly adapt and align our capabilities with emerging needs and opportunities in the biotech field.
DA: Could you discuss any current strategic alliances or partnerships that are crucial to NorthX's success?
JH: Certainly, our strategic alliances are integral to our growth and innovation. Our engagement with immuno-oncology company Mendus illustrates our commitment to advancing cell therapy solutions for acute myeloid leukemia, reflecting our ability to tackle complex biologics manufacturing. Our work on outer membrane vesicles with vaccine development company Abera Biosciences not only advances novel biotechnological approaches but also supports our strategic focus on non-viral delivery systems as a promising alternative to conventional viral methods.
Another strategic collaboration has been the recently completed OPENCORONA project (OPENCORONA | Karolinska Institutet), developing a DNA vaccine all the way to testing in humans, which was led by the Karolinska Institute, located near our Stockholm site. This project not only enhanced our connection with top European researchers from countries like Germany and Italy but also strengthened our network within a broad European alliance.
Additionally, we are part of AdBIOPRO, a competence center driven by the Royal Technical University in Stockholm, where we collaborate with several companies and the university itself to enhance bioprocessing techniques like cell culture processes. This consortium allows us to exchange ideas and tackle common challenges openly, enhancing our processes and solutions.
These collaborations are predominantly at the national and European levels, but we are actively looking to expand our alliances to include partners in the United States, which is still in the early stages. These strategic partnerships are vital as they foster innovation and allow us to stay at the forefront of technological advancements in the biopharmaceutical industry.
DA: One innovative area you mentioned is non-viral delivery systems. How do you view their potential?
JH: Viral delivery systems received considerable attention in the development of gene therapies, but there remains a degree of skepticism about their widespread application beyond infectious diseases and vaccines. This opens the door for the development and integration of non-viral delivery methods, which I believe are crucial for diversifying treatment options. For example, our involvement developing and manufacturing a DNA vaccine as part of the OPENCORONA consortium included techniques like electroporation, which, while not a universal solution, illustrates the potential for physical methods of delivery.
We are exploring various non-viral approaches, such as outer membrane vesicles and lipid particles, which are less immunogenic and toxic and thus provide a potentially safer alternative to traditional viral methods. These innovations are promising not only because they offer a counterbalance to viral delivery's limitations but also because they expand capabilities in biologics, making treatments more adaptable and less prone to causing immune reactions. As these technologies mature, they will become increasingly important to our strategy, complementing our existing suite of solutions and potentially leading the way in next-generation biopharmaceutical development.
DA: As the pharmaceutical industry begins to move toward more personalized and precision therapies, how is NorthX preparing to adapt to these emerging demands for smaller, more individualized batch production?
JH: NorthX is actively preparing for the shift toward more personalized therapies, particularly in cell therapy, which by nature requires a more tailored approach. For instance, while it isn’t itself a personalized therapy, the allogeneic cell therapy we produce for Mendus is manufactured with technology that aligns well with the personalized therapy model.
Additionally, we are assessing the potential for personalized therapies at our Matfors facility to ensure the rapid turnaround times that such treatments require. Looking ahead, it's clear that the broader adoption of personalized therapies will necessitate a significant focus on cost reduction, both in clinical and manufacturing contexts. As the industry progresses, and potentially hundreds of cell and gene therapies become registered, managing and minimizing costs will become even more critical. This focus on cost-efficiency is likely to become an integral part of the innovation environment as we adapt our facilities and processes to accommodate these evolving demands.
DA: Sustainability is increasingly becoming a priority in biopharma. Can you discuss how NorthX is addressing sustainability in its operations and the importance of these efforts both for your customers and internally?
JH: Sustainability is a critical component of our operations and is deeply valued by our customers and staff. We are committed to using only green energy and meticulously managing our waste, aiming to minimize our environmental footprint. We also balance the use of single-use systems with stainless steel in manufacturing to mitigate the environmental impact, particularly where single-use systems can be avoided.
Beyond environmental considerations, we emphasize social sustainability through various community engagement and educational initiatives. We actively participate in local and national educational programs, contributing to leadership development and fostering career opportunities for students, which aligns with our broader commitment to societal improvement.
Moreover, our approach to sustainability isn't just about minimizing harm; it's about actively contributing to the community and setting a standard for responsible business practices in the life sciences sector. I believe it’s essential to give back — I see competence development as a circular process, both in regard to sharing experiences to support people in the beginning of their careers and fostering further scientific advancements. This holistic view on sustainability — spanning from green practices to social responsibility — is integral to our mission and is increasingly recognized as vital by our customers.
DA: To wrap things up, how do you see NorthX building upon your foundation and your current differentiators and continuing to evolve along with your customers?
JH: At NorthX, our philosophy is encapsulated by the phrase “Beyond CDMO.” We aim to be more than just a contract development and manufacturing organization; we focus on understanding our clients' needs and growing alongside them throughout their development journey. This approach means we don’t just execute prescribed tasks; we engage deeply with our clients, fostering strong, lasting relationships whether the clients are large or small. This commitment to client-centric partnerships is what truly differentiates us in the industry.
Looking ahead, the biologics manufacturing landscape is poised for significant changes, driven by advancements in personalized medicine and other emerging modalities. We see ourselves continuing to be at the forefront of developing and manufacturing complex proteins and cell and gene therapies. Another area we are keenly focusing on is how our Innovation Hub and manufacturing capabilities can enable pandemic preparedness, ensuring that regions and countries are better equipped for future health crises, a direction that has gained momentum since the COVID-19 pandemic.
Overall, our goal is to lead in innovation and adaptability, staying ahead of industry trends and aligning our capabilities with the evolving needs of the biopharmaceutical sector.
