HIPRA’s development toward BIMERVAX® began in the earliest days of the COVID-19 pandemic, when the company, based on its knowledge and background in vaccines, decided to engineer a next-generation antigen capable of addressing the evolving viral landscape. These efforts ultimately lead to the development of HIPRA's recombinant RBD-dimer antigen. Collaboration with leading research institutes, continuous variant monitoring, and a flexibility to pivot, even when clinical trials were about to commence, resulted in a vaccine that ultimately earned European authorization and WHO recognition. The program required HIPRA to enlarge and adapt their existing analytical, regulatory, and GMP capabilities at unprecedented speed — capabilities that now form the foundation of a permanent expansion into human health. Through HIPRA Biotech Services, a biologics contract development and manufacturing organization (CDMO) launched in early 2025, the company is making the scientific rigor, platform expertise, and rapid-response operational model forged during the BIMERVAX® journey available to biopharma partners worldwide.
Mobilizing Decades of Expertise in the First Months of the Pandemic
When SARS-CoV-2 emerged in early 2020, and HIPRA began considering contributing to the global efforts to develop vaccines to combat the COVID-19 pandemic, the company was not starting from zero. HIPRA had spent decades studying coronaviruses in poultry and cattle, and its research teams had developed a strong grasp of coronavirus biology, and the structural motifs most relevant to neutralizing immunity, albeit in species very different from human. That foundation created both the capability and the obligation to contribute meaningfully to the global emergency.
Within days of the SARS-CoV-2 genome becoming available, HIPRA launched exploratory antigen-design work, which resulted in multiple prototype formulations with encouraging preclinical immunogenicity data. But as the epidemiology evolved, the company continued evaluating next-generation constructs, and, eventually, emerging experimental data showed that a single-chain heterodimer incorporating Alpha and Beta RBDs produced substantially stronger neutralization than the original Wuhan-based candidate. Although HIPRA was ready to initiate a phase I trial with the latter, the evidence prompted a decisive shift: the company paused the initial program and advanced with the superior heterodimer instead.
Phase I began in August 2021, and the resulting vaccine — later named BIMERVAX® (registered trademark in the European Union) — received European marketing authorization in March 2023. HIPRA has since updated the antigen twice in alignment with international recommendations, including a monovalent XBB.1.16-based version and the current LP.8.1 version to fit into epidemiological landscape. Today, BIMERVAX® is one of the few COVID-19 vaccines offered across Europe—an outcome that reflects not only the strength of the underlying platform but also HIPRA’s willingness to make bold scientific choices when they matter most.
Decades of Antigen–Adjuvant Engineering Applied to a New Human Challenge
HIPRA entered COVID-19 vaccine development with decades of experience designing vaccines based on different approaches, such as recombinant antigens and formulating adjuvanted subunit vaccines — expertise built across numerous veterinary pathogens but the company has successfully demonstrated it to be directly applicable to human immunology. This background made a recombinant protein approach both scientifically sound and strategically differentiated. From the earliest days of the pandemic, HIPRA believed the global response would require multiple complementary vaccine technologies, not a single platform. Recombinant protein vaccines offer advantages for populations where reactogenicity, durability, and safety profiles are paramount.
Early exploratory work confirmed the strength of this strategy. In side-by-side evaluations of several antigen constructs, recombinant RBD candidates consistently produced stronger and more targeted neutralizing responses than full-length spike proteins in preclinical models. These results were fully aligned with HIPRA’s long-standing use of structure-guided antigen engineering, which served as the basis for the design and optimization of coronavirus vaccines in multiple animal species.
Recombinant protein vaccines also offered practical and regulatory advantages during such an emergency. Their excellent safety and tolerability profiles made them particularly suitable for older adults, immunocompromised individuals, and pediatric populations.
On the manufacturing side, HIPRA relied on its extensive experience producing recombinant antigens at industrial scale. The COVID-19 antigen was expressed in CHO cells, a platform that provides robust expression, high yields, and predictable scalability. CHO systems also support efficient purification strategies and tight control of critical quality attributes, an essential requirement for European Medicines Agency (EMA) review and later World Health Organization (WHO) prequalification.
Another advantage of recombinant subunit vaccines is their inherent thermal stability: BIMERVAX® can be stored and transported at standard refrigerator temperatures, improving global distribution and enabling deployment in regions where ultra-cold infrastructure is limited.
Perhaps most importantly, HIPRA’s decades of experience with more than 300 animal pathogens had already equipped the company with deep capabilities in process development, analytical characterization, and GMP biologics manufacturing. These capabilities, supported by a flexible and well-established facility network, allowed HIPRA to move from laboratory prototypes to large-scale production at an unusual speed. When BIMERVAX® entered clinical development, HIPRA already possessed the infrastructure, quality systems, and operational maturity required to manufacture substantial volumes under pandemic conditions.
Engineering a Distinctive RBD-Dimer Antigen for Broad Variant Protection
HIPRA’s decision to pursue a next-generation antigen based on emerging SARS-CoV-2 variants was only one dimension of its strategy. Equally significant was the choice to design an antigen fundamentally different from those used in most authorized COVID-19 vaccines. Whereas many vaccines rely on the full spike protein, HIPRA focused on the RBD — the region of spike that engages the ACE2 receptor and the dominant target of neutralizing antibodies. Preclinical immunogenicity studies conducted at HIPRA with several initial antigen constructs consistently showed that RBD-based designs elicited stronger, more focused neutralizing responses than full-length spike, validating the scientific rationale for a targeted subunit approach.
HIPRA then advanced the concept further: instead of producing a standard monomeric RBD, the team engineered a single-chain dimeric protein in which two RBD domains are covalently linked. This architecture can be configured as a homodimer (two identical RBDs) or a heterodimer (two variant-derived RBDs). The original BIMERVAX® formulation used a heterodimer incorporating Alpha and Beta sequences, which broadened immune coverage across circulating strains. The distinctive dimeric geometry also contributed to the vaccine’s strong booster performance by presenting two antigenic landscapes simultaneously within a stable, manufacturable protein format.
As international regulatory guidance has shifted toward monovalent vaccines based on a single lineage, HIPRA has aligned its subsequent BIMERVAX® updates with EMA, WHO, and U.S. Food and Drug Administration (FDA) recommendations. The two most recent versions thereof use homodimeric RBD constructs, including the newest monovalent LP.8.1-based antigen. Nevertheless, despite the excellent performance of the homodimeric RBD constructs, HIPRA continues to generate data supporting the scientific value of heterodimer constructs. Early findings suggest that bivalent single-chain dimers may deliver a fuller neutralization breadth, protecting not only against closely related variants but also against more antigenically distant strains. As regulatory frameworks evolve, HIPRA anticipates that dual-variant dimers could again play an important role in vaccine strategies aimed at durable, wide-spectrum immunity.
Development of the RBD domains incorporated into BIMERVAX® was guided by a combination of high-throughput immunogenicity screening, structural modeling, and HIPRA’s deep knowledge of coronavirus immunobiology across species. Crucially, the verified RBD constructs were not only more immunogenic; they were also far more manufacturable. Full-length spike proteins are large, structurally complex, and intrinsically unstable, making them difficult to express and purify at scale. By contrast, RBD dimers expressed in CHO cells exhibit higher titers, cleaner purification profiles, and more consistent quality attributes, enabling reliable industrial-scale production and facilitating global regulatory review.
Translating Outbreak-Response Agility into Human Vaccine Development
For more than five decades, HIPRA has developed and manufactured vaccines for diverse animal species, often in the context of rapidly evolving or unpredictable disease outbreaks. This environment conditioned the organization to work with incomplete information, respond to epidemiological shifts in real time, and mobilize manufacturing resources at speed. Rapid decision-making, scientific agility, and operational resilience are therefore not crisis adaptations for HIPRA — they are built into the company’s operating culture. When COVID-19 emerged, these capabilities became immediately relevant.
HIPRA had already been assessing strategic entry into human vaccines, but the level of investment required made the move difficult to justify under normal circumstances. The pandemic fundamentally changed that equation. The company quickly recognized both the severity of the global emergency and the direct applicability of its own strengths: deep experience with coronaviruses, established recombinant protein platforms, and flexible GMP facilities capable of absorbing new processes without disrupting ongoing veterinary programs. Under those conditions, contributing to the pandemic response was not just feasible — it was imperative.
This mindset empowered HIPRA to take bold scientific and operational decisions that many organizations would have avoided. The company was willing to pause a near-ready clinical package, redesign its antigen, and reallocate internal development capacity when emerging data indicated that a superior vaccine was achievable. These choices reflected the same principles HIPRA has long applied in animal health: scientific excellence in following the evidence wherever it leads, optimism in pursuing better solutions even under uncertainty, and a non-conformist willingness to depart from established paths when public-health impact demands it — even at the cost of short-term operational risk. The experience of developing BIMERVAX® validated HIPRA’s ability to translate its veterinary vaccine agility into the rigor of human vaccine development. It broadened the landscape of available COVID-19 technologies and demonstrated that HIPRA's scientific depth, manufacturing flexibility, and crisis-tested decision-making can meaningfully contribute to human health.
Although the exploratory phase of vaccine discovery mirrors many of the approaches used in veterinary medicine — screening CHO cells, microbial systems, yeast, or insect-cell platforms to identify antigens with the best stability, quality, safety and immunogenicity profiles— the transition to human vaccine development demands far greater analytical depth, process control, and regulatory rigor. Once BIMERVAX® moved beyond antigen development, the expectations for product commercialization expanded dramatically, including method robustness, reproducibility and validation across sites, detailed comparability packages, a full quality-by-design (QbD) framework and mapping the design space, and establishing statistical relationships of critical process parameters (CPPs) and critical quality attributes (CQAs), all while accomplishing this work under accelerated timelines.
The BIMERVAX® program ultimately became the bridge into HIPRA’s next chapter, providing the foundation of capabilities, systems, and institutional confidence that now underpin HIPRA Biotech Services.
From Innovator to CDMO: How BIMERVAX® Catalyzed HIPRA’s Expansion
The COVID-19 program did more than accelerate HIPRA’s entry into human health — it fundamentally reshaped the company’s strategic trajectory. Developing BIMERVAX® required HIPRA to expand or establish capabilities across every stage of the human vaccine value chain: antigen design, process and analytical development, GMP manufacturing, clinical and regulatory documentation, and global quality-system alignment. By the time the vaccine received European authorization in 2023 and later obtained WHO prequalification, HIPRA had demonstrated that it could discover, develop, industrialize, and license a complex recombinant biologic for human use under highly compressed timelines.
While HIPRA is actively commercializing BIMERVAX® across Europe and advancing its global rollout, the program also prompted a broader strategic realization. The scientific platforms, manufacturing expertise, and operational flexibility built during BIMERVAX® had value well beyond a single product and could be applied to support other organizations developing biologics and vaccines.
This realization led to the creation of HIPRA Biotech Services, formally launched in early 2025 as a dedicated contract development and manufacturing organization (CDMO) within the HIPRA Group. The new business leverages the same scientific depth, proficiency in developing scalable processes, analytical sophistication, and GMP manufacturing strength that enabled BIMERVAX® but applies them to support external innovators across the global biopharmaceutical and vaccine ecosystem.
HIPRA Biotech Services offers emerging biotechs and established pharmaceutical companies access to proven development and manufacturing platforms, which in the case of BIMERVAX® has recently succeeded under some of the most demanding scientific and regulatory conditions in modern vaccine history. Through this CDMO model, HIPRA can extend its contribution to human health far beyond a single product, enabling partners to benefit from the technologies, infrastructure, and multidisciplinary teams forged during the BIMERVAX® journey.
Engineering a Recombinant Platform Designed for Modern Biologics Speed
Speed has become a defining variable in biopharmaceutical innovation. Companies advancing vaccines, biologics, and emerging modalities increasingly need partners who can compress early development timelines without compromising scientific rigor or product quality. CDMOs capable of moving efficiently from antigen design to process development, scale-up, and GMP manufacturing offer a meaningful competitive advantage, particularly when programs must respond to fast-moving epidemiology or evolving clinical strategies.
HIPRA Biotech Services was created with this need in mind. The company is refining its recombinant protein platform to support significantly faster development cycles. A cornerstone of this effort is Project SPEEDCELL, an initiative funded by the European Commission under the EU4Health Programme.
SPEEDCELL’s mandate is ambitious: to enable recombinant proteins and antigens — traditionally associated with longer development cycles — to align with the 100-day mission for rapid response to emerging health threats, compressing timelines from antigen selection through GMP readiness. HIPRA is the sole industrial partner selected for this initiative, reflecting the commission’s confidence in the company’s antigen-engineering capabilities, its demonstrated ability to industrialize complex biologics under compressed schedules, and the maturity of its analytical and GMP infrastructure.
For CDMO partners, these investments deliver direct, practical benefits to advance their recombinant protein-based drugs via a proven pathway. Accelerated platform processes, more standardized analytical packages, and integrated scale-up strategies shorten the path to first-in-human studies and reduce uncertainty during later clinical phases. SPEEDCELL strengthens HIPRA Biotech Services’ ability to provide not only robust development and manufacturing solutions but also development at a pace aligned with the demands of modern biologics programs and future public-health emergencies.
A Proven Development Engine Now Available to Biopharma Innovators
What enabled HIPRA to move from concept to clinical evaluation in record time was not a singular response to a crisis but the culmination of more than five decades spent developing vaccines across species, disease areas, and manufacturing platforms.
HIPRA’s long history in animal health — spanning more than 300 zoonotic and economically significant pathogens — has produced a uniquely broad foundation in antigen design, immune-response optimization, and rapid-response bioprocessing. Across its portfolio, the company has industrial experience with recombinant proteins, viral antigens, bacterial expression systems, mammalian cell culture and microbial manufacturing platforms, and a diverse range of adjuvant technologies. Equally important, HIPRA has spent decades navigating seasonal and outbreak-driven surges in demand, building the ability to scale, pivot, and make evidence-based decisions under pressure. These operational instincts translated directly into its ability to execute decisively during the COVID-19 crisis.
The BIMERVAX® program validated this accumulated expertise under the most demanding conditions imaginable: rapidly evolving variants, shifting epidemiological targets, stringent regulatory expectations, and the need to build full human-vaccine capabilities without disrupting essential veterinary programs. The systems, workflows, and scientific mindsets refined during this period are now fully embedded within HIPRA Biotech Services.
For biopharmaceutical companies seeking a partner able to accelerate development timelines, manage technical complexity, and de-risk technology transfer, HIPRA Biotech Services offers a development and manufacturing engine proven in a real-world global emergency, now dedicated to enabling client programs.
