“We invest emotionally and intellectually in their journey—when their product reaches patients, that’s our success too.”
Janet Hoogstraate, CEO of NorthX Biologics, brings ~30 years of pharmaceutical experience spanning from preclinical development to GMP production for marketed products, with leadership roles at Valneva and AstraZeneca. Her experience from both the CDMO and sponsor sides contributes to NorthX’s approach to developing advanced biologics in extended collaboration with the innovative product companies.
The contract development and manufacturing organization (CDMO) landscape is evolving beyond transactional relationships toward integrated partnerships. In this podcast, recorded at Nordic Life Science Days (NLSDays) in Gothenburg, Janet outlines how CDMOs can function as strategic partners rather than service vendors, sharing insights from an interactive workshop on growing CDMO relationships alongside clinical development.
Building Relationships on Mutual Investment
Traditional CDMO-sponsor dynamics often follow rigid structures: sponsors provide specifications, CDMOs execute processes, and deliverables change hands with minimal integration. Janet advocates for a fundamentally different model.
“We see ourselves as partners in the biotech’s success,” Janet explains. “It’s not merely that you give me a recipe that I execute and then hand back the product. It’s really an intimate collaboration to contribute to the biotech’s success.”
This partnership mentality requires CDMOs to bring more than manufacturing capabilities to the table. NorthX uses its CMC expertise—including process development, optimization, and GMP manufacturing—as a valuable asset that biotechnology companies can use at each stage of their development journey.
The integration extends to team structures. “Being part of each other’s project teams is really important,” Janet emphasizes. Rather than maintaining separate organizational silos where responsibilities are rigidly divided, effective partnerships embed CDMO expertise within biotech development teams and vice versa.
Breadth Vs Depth
NorthX Biologics’ capability portfolio spans proteins, antibodies, extracellular vesicles, plasmid DNA, viral vectors, and other advanced biologics—a broad range for a medium-sized CDMO. Janet explains how the company maintains expertise across these modalities.
“It starts with either microbial or mammalian expression systems, and at NorthX, we have deep knowledge in how you culture cells or bacteria. To that we add our downstream processes expertise,” she notes. “You can use that knowledge to make different modalities.”
The underlying manufacturing principles share technical similarities across different biologics. Extracellular vesicles and outer membrane vesicles, for example, draw on existing cell culture and bacterial fermentation capabilities. “We can definitely build on the experience we have from producing proteins, plasmid DNA, and viruses,” Janet says.
She notes that while NorthX has mRNA capabilities, that modality “hasn’t really taken off” and receives less emphasis. The company instead prioritizes protein and vesicle-based modalities for therapeutics and vaccine development.
Timing CDMO Engagement
Workshop discussions at NLSDays revealed that timing a CDMO engagement remains a persistent challenge for biotechs. Janet recommends early interaction.
“The sooner you engage with experts, the better,” she advises. “That doesn’t have to be the CDMO right away. You could interact with a CMC consultant to make sure you’re on the right track.” Process development benefits from expert input during initial design phases. Small biotechs typically possess strong biological and clinical expertise but may lack CMC depth. Early consultation prevents costly late-stage corrections when development timelines and regulatory commitments limit flexibility.
“Well before GMP, you need to have your relationship established with the CDMO so you can really build the process together in their facility and work on a long-lasting plan,” Janet emphasizes.
The workshop identified tech transfer as a potential value-inflection point, though participants debated which CMC milestone most significantly boosts company valuation. Later-phase milestones—particularly Phase 2 completion and Phase 3 transition to commercial manufacturing—garnered strong consensus as value drivers. “Phase 2, when you go into patients, is where it becomes easier for a biotech to interact with investors and get traction,” Janet observes. Demonstrating mechanism-of-action validation in patients provides the data investors prioritize.
Trust as the Partnership Foundation
Workshop participants repeatedly emphasized trust and communication as partnership cornerstones. From Janet’s perspective, trust develops through continuous, transparent dialogue rather than rigid contractual structures.
“Trust is something you need to build up through continuous communication,” she explains. “When communication is lacking or not optimal, that’s the start of losing trust.”
Maintaining trust requires ongoing effort beyond initial relationship establishment. Janet recommends periodic reflections on team performance, recognizing that “the relationship isn’t always friction-free. Things will happen, and you will have problems here and there that you need to solve together.”
When trust deteriorates, her first recommendation prioritizes repair over replacement. “If the trust is broken between a biotech and a CDMO, the first thing to do is try to fix it rather than just walk away,” she advises. Both parties have invested significantly in the relationship and established institutional knowledge. “Talk about it. How can we bring each other together again?”
CDMO changes usually stem from factors beyond trust breakdowns: capacity needs, cost considerations, or geographic proximity. Workshop feedback suggested that sponsors value CDMOs located within a reasonable travel distance for regular site visits and hands-on collaboration.
Sweden’s Collaborative Infrastructure Advantage
NorthX Biologics operates as a designated national innovation hub for advanced therapeutics and vaccines—a recognition that reflects Sweden’s collaborative ecosystem approach. “Sweden has a culture of collaboration between academia, industry, small and large pharma,” Janet notes. “It’s in our DNA, this collaboration.”
“We offer our infrastructure, knowledge, and experience to people who need it,” Janet explains. Academic entrepreneurs lacking manufacturing infrastructure can partner with facilities like NorthX during company establishment.
This collaborative framework aligns with NorthX’s partnership philosophy. “You don’t do things completely on your own. You try to collaborate with others so you can complement experiences and capabilities,” Janet says. “When a client needs go beyond our capabilities, we form external partnerships to ensure our client’s requirements can be met.”
Janet envisions expanding this model through European consortium participation and collaborative grant funding. “We strongly believe this Swedish mindset of collaboration can definitely be exported between other countries as well,” she notes.
Future Integration Models
Looking forward, Janet anticipates deeper structural integration between CDMOs and biotech sponsors. “In the next phase, there will be more integration between the two partners,” she predicts. “We will be more integrated in the development journeys, almost like embedded teams.”
This evolution requires CDMOs to engage earlier in strategic planning rather than responding to established specifications. “Let them see your challenges, not just your purchase orders,” Janet advises biotech leaders. “Choose a partner that listens and adapts and feels like part of your team.”
