Canada Biomedical Research Fund and Biosciences Research Infrastructure Fund
Award Recipients: Stage 2

For a pandemic-ready Canada, it is critical for us to have the capacity to run the path from pathogen identification to clinical-phase-ready vaccines and therapeutics in the shortest time possible. To achieve this goal, reliable, scalable, and adaptable biomanufacturing processes are key.

RAMP-UP links the pathogen identification to clinical trial scale production of biologics, towards this goal. It will deliver versatile bacterial and mammalian cell lines platforms able to: 1) design efficient and manufacturable biologics; 2) develop their scalable bioprocesses and associated analytical technologies; 3) reliably mass-produce the formulated biologics, including sterile-fill-finish end step within one hundred (100) days.

RAMP-UP brings manufacturing process solutions directly answering the current and foreseeable needs of biopharmaceuticals and Contract Manufacturing Organizations alike, including GMP aspects, in line with their highest priorities. To maximize efficiency in answering the needs of its strategic Industry partners, RAMP-UP will work closely with its technology transfer partners to optimize the successful “to market” transfer of its innovations. In effect, RAMP-UP will facilitate shortening the discovery to commercialization path.

Concurrently RAMP-UP will provide, the desperately needed highly qualified personnel to staff facilities, governmental academic and industrial alike, through a unique and proven, co-training program. Focused on enabling interdisciplinary and intersectoral collaboration skills in trainees, it will aim at breaking down the historically persistent silos existing in the biopharmaceutical sector.

In concert with the National Research Council of Canada and the Canadian Network of Scientific Platforms, RAMP-UP is the one initiative ready to provide a robust and truly pan-Canadian strategy in response to the next pandemic for all Canadians from coast to coast to coast.

Because antibiotics are overused, some of them no longer kill “superbug” bacteria. This problem, called antimicrobial resistance, means we need to find new antibiotics. In 2019, more people died from superbug bacteria than from COVID-19 in 2020-21. These superbugs kill 5,400 every year in Canada. However, very few antibiotics are being developed because the process is long and expensive for the pharmaceutical industry. This leaves Canadians vulnerable, especially if we are faced with another pandemic.

Based on the problems in the COVID-19 pandemic, our industry partners determined that Canada has the following needs to better fight current and future superbugs, pandemic-style: we need to use Canada’s leadership in artificial intelligence to discover new antibiotics, and we need to develop processes to make chemicals locally so we don’t depend on other countries for supplies.

Using artificial intelligence and other technologies, we will study how bacteria react to chemicals, use that information to find new antibiotics that kill bacteria, and ensure that those antibiotics are not toxic to humans. Then we will determine how to make these antibiotics in Canada. These activities will allow our industry partners to make enough of the new antibiotics for clinical studies to test their safety.

As a result, Canada’s response to ongoing antimicrobial resistance will be faster and stronger and will help solve future global health threats. Using artificial intelligence and focusing on drug discovery will help Canadians find good jobs in these sectors.

Our research aligns with 4 pillars of Canada's Biomanufacturing and Life Sciences Strategy: Strong and coordinated governance; Laying a solid foundation by strengthening research systems and the talent pipeline; Growing businesses by doubling down on existing and emerging areas of strength; and Building public capacity.

The 2023 USA National Academies of Sciences report on non-human primates (NHP) needs considers NHP: “to be necessary to support key strategic priorities…, including maintaining global leadership in biomedical science and safeguarding… against unexpected public health threats”. NHP are key models for infectious diseases and are essential for pre-clinical studies in vaccine and drug development. The COVID pandemic exposed limited animal resources and the difficulties with international NHP trade. Canada's sovereignty for pandemics preparedness requires NHP capacities as we have no breeding facilities, and a crying need for additional level 3 containment laboratory (CL3) handling NHPs to support the study of vaccines and therapeutics against (re)emerging pathogens. This is a crippling void in our country’s biomanufacturing ecosystem (BE). We will leverage from our mounting NHP knowledge and expertise (more than 10 years’ experience) to enrich the BE, by creating the National Primate Center for Pandemic Preparedness (NPCPP) and built a continuum starting from NHP breeding, up to effective research translation into clinical development. Our objectives are to: 1) supply NHPs and related research models to the BE, as well as; 2) offer cutting-edge bioimaging for large animals under ; 3) GLP-specialized CL3 premises. The upcoming Québec’s cyclotron will provide custom isotopes for animal PET/CT-scan analyses, filling another gap in the BE. This optimized infrastructure will support national networking, complement existing facilities, and be a unique site for HQP training. NHP made available for pre-clinical studies supported by CL3+GLP services will feed national bioindustry while accelerating translation of research deliverables into commercial products. Thus, NPCPP will be directly aligned with the Canadian Biomanufacturing and Life Sciences Strategy, and fulfill domestic needs while positioning Canada amongst international leaders.

During the COVID-19 pandemic, POPCORN was created to unite investigators from all children’s hospitals (16) and pediatric networks in Canada and create a multidisciplinary approach to pediatric research. Despite the outstanding work done by this “network of networks”, few gaps still exist in the ability to respond to the next pandemic in Canada: 1) inability to rapidly conduct clinical trials in children and pregnant people, 2) paucity of real-time data to inform evidence-based policy decisions and, 3) inability to capture the full trajectory of a child’s illness. With this proposal, our goal is to build upon this unique research structure (now termed POPCORN 2.0) to quickly identify and comprehensively study all emerging infectious diseases in children and pregnant people and maximize the capacity and readiness to include them in clinical trials. To do so, POPCORN 2.0 will: i) collect and bank residual serum and respiratory samples from children and pregnant people across Canada, ii) link all sites’ data warehouses for syndromic surveillance and long-term outcomes assessment, and iii) streamline contracting, ethical review and data/material transfer agreements to expedite clinical studies and trials. Through these activities, we will be the primary national maternal-child health source for disease surveillance and pandemic preparedness, with harmonized clinical databases and the largest pediatric biobank worldwide to support researchers and decision-makers alike. Also, we will serve as the “one-stop shop” for private and academic partners to streamline the conduct of clinical studies and interventional trials. As such, POPCORN 2.0 represents an invaluable resource for Canada’s Biomanufacturing and Life Sciences Strategy and ECaPPH’s vision by radically improving the capacity for discovery and surveillance of infectious diseases and speeding up the translation from research to provision of life-saving therapies and vaccines to some of the most vulnerable Canadians.

Globally, countries were unprepared for the COVID-19 pandemic and Canada was no exception. Border restrictions were imposed in attempts to mitigate disease spread, yet efforts in North America were generally ineffective at containing the spread of COVID-19. Despite closed borders, cross-border trade continued between Canada and the US, albeit chronic supply shortages limited biomanufacturing capacity and our ability to deliver healthcare with consequent negative economic and societal effects. To build resilience in Canada’s biomanufacturing ecosystem, we must learn from experience to develop proactive strategies to prevent the devastating impact of infectious diseases on the biomanufacturing and health sectors and improve efficiencies moving assets across borders.

INSPIRE integrates three areas required to instil resilience and build capacity in the biomanufacturing sector in Canada: 1) biomanufacturing and health sector supply chains, 2) cross-border trade and mobility, and 3) robust and timely pathogen surveillance supported by novel technology development. Anchored by a cross-cutting pathogen surveillance platform that prioritizes community-level wastewater surveillance, INSPIRE occupies a unique position within the Canadian Hub for Health Intelligence and Innovation in Infectious Diseases (HI3) to strengthen and support the multiple themes within the HI3 portfolio. Leveraging INSPIRE’s role to validate wastewater data into demand signals that inform biomanufacturing supply chains through biothreat alerts, we will serve HI3 and other Canadian Hubs by sharing pathogen surveillance data to alert partners to pathogens circulating within our proposed pathogen surveillance corridor. In turn, pathogens identified may be targeted to produce diagnostic tests, vaccines and therapeutics.

Training highly qualified personnel (HQP) is key for a strong Canadian biomanufacturing and life sciences ecosystem–underpinning made-in-Canada medical countermeasures and public health policies that will prevent the consequences experienced during the COVID-19 pandemic from repeating in future health emergencies. By integrating existing and new training infrastructure and expertise from research, training, translation and industry partners, and linking it with programmatic research across HI3 institutions, the BioManufacturing Hub Network (BioHubNet) will tailor training pathways with core and specialized components, including research, technical, transferrable and translational skills, with an industry-ready focus. Multidisciplinary experiential learning will embed trainees in research projects within and beyond academia through strong partnership with industry and not-for-profit organizations–Mitacs will support 300 student placements and linkage with other hubs will promote national mobility. BioHubNet will support the three HI3 hub themes: Precision Interventions, Process Innovation and Health Intelligence, with a leadership team experienced in connecting training with applied research, and linkage to 16 HI3 CBRF/BRIF Stage 2 proposals, as well as to strategic initiatives with a track record in pandemic-focused research and training. By leveraging these and additional ecosystem assets, BioHubNet will train 500+ interdisciplinary HQP who will in turn support research programs to move through and beyond proof-of-principle, delivering real-world evidence and solutions including regulatory and clinical trials frameworks, policy briefs, technology dossiers, licensing agreements, and rapid multi-domain data analysis, and creating new companies through entrepreneurship and commercialization streams. This effort will deliver HQP and research advances essential for promoting the health and well-being of Canadians in future pandemics and health emergencies.

The Prepare, REact, Collect, Innovate, Share and Engage (PRECISE) Diagnostic Platform is designed to elevate Canada’s ability to diagnose and respond to emerging infectious diseases. Our interdisciplinary team including clinicians, virologists, immunologists, and biochemists, together with patients, public health agencies, and industry partners is poised to create a flexible, biomanufacturing-centric approach, building on our previous experience with SARS, COVID-19 and mpox.

Our core objectives are to:

1. Collect data and biospecimens from patients with infectious diseases.
2. Profile pathogens and host responses.
3. Develop and refine diagnostic and immune-monitoring tests.
4. Co-create an engagement platform with community partners.

These goals are tailored to expedite diagnostics and enhance the effectiveness of vaccines and therapeutics. PRECISE is designed around an 'interpandemic' phase, continuously fine-tuning protocols with exemplar infectious diseases. Should a threat emerge during the study period, pre-established agreements and protocols and trained personnel will enable us to pivot rapidly to address it.

Collaboration is a cornerstone of PRECISE. Biospecimens will be shared with clinical laboratories, academics (including other HI3 groups), public health laboratories and industry partners for rapid development of diagnostics and swift product validation. We will actively engage with public health and patient partners to ensure that our approach is tailored to the needs of those most affected.

Our ultimate goal is to ensure the rapid scale-up and sustainable manufacturing of crucial diagnostic tools. We commit to capacity-building by training highly qualified individuals through cross-disciplinary, diverse, and equitable mentorship programs and placements.

By merging clinical expertise with innovative biomanufacturing solutions and fostering robust partnerships, PRECISE will fortify Canada's resilience against future pandemics.

SARS, SARS-CoV-2, mpox, and other threats have revealed significant weaknesses in our public health system. Novel pathogens are most likely to present to primary care clinics and emergency departments. PREPARED will engage these sites in surveillance, pandemic early warning, bridge practice and biomanufacturers, and boost recruitment to trials.

PREPARED has four interrelated objectives: 1) Enhance surveillance: Implement and evaluate a scalable system that engages primary care and emergency departments in collecting specimens from patients presenting with acute respiratory infections, alongside automated electronic medical record (EMR) analysis. This surveillance data will help identify novel infectious agents, monitor the evolution of known pathogens, and enhance pandemic preparedness. 2) Improve patient care and health system efficiency: Implement and evaluate a standard approach to acute respiratory infections, including the latest point-of-care multi-pathogen rapid antigen tests to identify the specific virus or bacteria causing an infection. This will streamline clinical decisions, save time and reduce unnecessary antibiotic use. 3) Accelerate the biomanufacturing of diagnostics, vaccines and therapeutics: By sharing biospecimens with industry and supporting validation, vaccine efficacy studies and trials, we will expedite approval, reduce costs, and support access to products. 4) Facilitate linkage to clinical trials: Connect patients who have acute infections to clinical trials funded publicly and by industry that test new treatments and diagnostics.

Our project engages 15 industry partners, 16 primary care practice-based research networks, which collectively serve >2.5 million Canadians, and emergency departments in 6 provinces. This leverages provincial and federal investments in the analysis of primary care EMR data, and a $10 million grant for CanTreatCOVID from CIHR and Health Canada, with support from the Public Health Agency of Canada.

To ensure that we have the biomanufacturing capacity we need, ready and sustainably waiting to mobilize in the event of a future pandemic or other health emergency, we have established the “Canadian Biomanufacturing Cooperative (CBC)”. Member facilities include the Alberta Cell Manufacturing facility (ACTM- Edmonton, Alberta), the OHRI’s Biotherapeutics Manufacturing Centre (BMC- Ottawa, ON), The Dalhousie Vector Challenge Facility (DVCF-Halifax, NS), The Fitzhenry Vector Laboratory (FITZ- Hamilton, ON), and the Vaccine and Infectious Disease Organization (VIDO- Saskatoon, SK). Together, the CBC has more than 100 highly qualified personnel, that have biomanufactured more than 20, discrete types of biologic therapies (e.g. oncolytic viruses, live virus vaccines, autologous and allogeneic cell products, nucleic-acid based vaccines) for Phase 1 and 2 clinical trials both within Canada and abroad for the past 15 years. Academically embedded GMP biomanufacturing facilities such as these, are mission critical to rapidly advance new, transformative therapies that treat indications like infectious diseases, genetic disorders and cancer. During a pandemic, these non-commercial, early-phase clinical trial facilities have the flexibility and knowhow to rapidly adapt existing processes, and if coordinated, can meaningfully contribute to a national biomanufacturing campaign. Conversely, during non-pandemic times, this purpose-built nimbleness enables these facilities to manufacture a wide range of investigational products, providing much-needed capacity to support Canadian clinical trials and de-risk new innovations for industry uptake. As the cornerstone of the CP2H hub, the CBC will function as a coordinated and harmonized network of Canada’s most experienced, early-phase biomanufacturing facilities with the consolidated, complimentary, and redundant capacity needed to support a strong and resilient biomanufacturing ecosystem in Canada.

Regulated pharmaceutical biomanufacturing is required to make vaccines, therapeutics, and diagnostic reagents. Biomanufacturing requires precise specifications and tight process controls to avoid the unpredictable and often harmful effects frequently encountered when manufacturing a product if the manufacturing process falls outside of a very narrow range of conditions.

Process Analytical Tools (PAT) are critical pieces of monitoring equipment needed for GMP manufacturing to ensure that the process stays within range. They provide a way of evaluating and measuring the contents and concentrations of the manufacturing media in near real-time to identify and control critical process parameters (CPP), which in turn affect the critical quality attributes (CQA) required for a successful batch and subsequent Quality Control testing.

This proposal is requesting funding to purchase PAT equipment, such as Raman spectroscopy and Fourier transform infrared (FTIR) spectroscopy, which are the latest types of PAT tools used at the beginning and end of the manufacturing process, respectively. The requested PAT tools will significantly aid process development efforts, decrease development time, increase batch success rates, and provide valuable process insight with the goal of bringing products to commercialization and aiding in Canada’s Pandemic Response. Spectrophotometric PAT will be applied to the process development, scale-up, and biomanufacturing components of at least five CBRF applications submitted to the HI3, PRAIRIES, and CP2H Hubs, and is in line with CP2H’s vision of transforming manufacturing pipelines so that Canada can pivot quickly in a pandemic.

This project aims to harmonize the infrastructure, technology and quality systems between six academic/ government GMP biomanufacturing facilities across Canada. Our plan is to functionally integrate these nodes of manufacturing excellence into a collaborative network of nimble GMP facilities that share innovations, improve efficiency, standardize product quality and position Canada to respond to inevitable future pandemics. Our collaborative network of distributed production facilities will increase efficiency and scalability of biomanufacturing processes, build resiliency into our supply chain, mitigate risks associated with single site manufacturing and provide standardized, high-quality training sites across Canada. The CP2H hub was designed to respond to the Coalition for Epidemic Preparedness Innovation or CEPI’s 100 day mission challenge by (1) creating a Trans-Canadian Biomanufacturing Co-operative; (2) establish high-performance translational research and development teams and; (3) create a network of regional experiential HQP training centres. The current proposal addresses all three of these goals and provides linkages to other hubs with interest in biomanufacturing.

This proposal combines world-class virology expertise and biocontainment facilities within the PRAIRIE Hub along with the RNA vaccine technologies and biomanufacturing capacity of Precision Nanosystems Inc in Vancouver, plus additional biomanufacturing capacity from the Canada Critical Drug Initiative (CCDI) organization in Edmonton to ensure global delivery. Targeting 3 different virus classes of very high pandemic potential, the deliverables are 1) to optimize self-amplifying (sa) RNA vaccines against Orthopoxviruses, Influenza viruses and Lassa viruses, 2) to demonstrate vaccine potency following viral challenge in vaccinated animals, 3) to develop scalable biomanufacturing facilities to ensure rapid delivery of these protective vaccines for the national and global populations, and 4) to have these biomanufacturing platforms ready to be activated quickly in the event of a different virus pandemic(s) occurring. Potentially, this proposal synergizes with related proposals from other Hubs focusing on developing more effective and safer lipid nanoparticles ( UBC Hub ), the use of naturally occurring exosome-type particles to package the saRNA ( Ottawa Hub ), and optimization of process development (McGill Hub). saRNA technology offers many potential advantages over mRNA platforms in requiring lower amounts of RNA particles thus accelerating large-scale manufacturing and vaccine delivery times as well as concomitant reductions in side-effects and in turn, less vaccine hesitancy. While self-amplification requires use of a larger RNA than mRNAs, Precision Nanosystems Inc not only provides their proprietary saRNA and lipid platforms but also their analytical tools and equipment to ensure quality and potency of the larger saRNA. Virologists within the PRAIRIE Hub along with world-class artificial intelligence expertise provided by UofA's AMII institute will design and optimize vaccines to be cross-protective against related viruses within each targeted viral class.

The COVID-19 pandemic revealed significant gaps in Canada's capacity to produce vaccines. We are a multidisciplinary prairie-wide team representing Universities of Manitoba (UM), Alberta (UA), Calgary and VIDO to support Canada's pandemic readiness. We will establish a Viral Vaccine Research and Development cluster centered around the PRAIRIE Hub. The cluster will develop a collection of virus-vectored and protein vaccine platforms that fulfill distinct outcomes such as efficacy, side effects minimization, ease of manufacturing and public perception. Our team, collaborators, partners, and advisors bring vast expertise in virology, immunology, infectious disease pathologies, artificial intelligence, machine learning, and bioprocessing to deliver 7 virus-vector platforms, 1 recombinant protein vaccine platforms, a one-of-a kind comparative vaccine analysis pipeline, and a manufacturing process development pipeline. Our integration of artificial intelligence to create rapid decision-making models and monitor manufacturing variations, as well as health economics to value impact throughout the project, are just some examples of our added innovation. Importantly, through our comprehensive vaccine development, testing and production pipelines, trainees will gain essential skills across the vaccine production spectrum that will empower them to fill essential gaps in Canadian vaccine production.

To further strengthen Canada’s vaccine production capacity, infrastructure is requested to establish a new biosecure Prairie Biologics Accelerator facility and a CL3 lab (UM) for vaccine development, pre-clinical testing, bioprocess development, diagnostics research, and training. The Prairie Immune and Vaccine Optimization and Testing core (UA) will provide specialized capacity to engineer, scale-up, and purify viral-vectored vaccines, but also an unparalleled immunology and pathology assessment pipeline for rapid vaccine comparative analysis and ultimately best vaccine choice.

The COVID-19 pandemic has underscored the central role of diagnostic testing in managing the response to an emerging pathogen. The primary objective of this program is to develop complementary techniques, including both point-of-care and high-throughput diagnostic assays. Building on our successful assays for SARS-CoV-2 in diverse specimens and using additional proof-of-principle targets such as respiratory pathogens (invasive pathogen group A streptococcus), sexually transmitted infections (syphilis), and blood-borne pathogens (hepatitis C), we will establish rapid diagnostic tools that are modular, transferable, and readily deployable. We recognize the critical importance of emerging respiratory viruses of zoonotic origin and will design our techniques and use specimen types to be quickly adaptable to detect these emerging pathogens. As an added benefit, this pandemic preparedness research will help improve health equity by incorporating a patient-oriented approach that will identify the unmet diagnostic needs of marginalized populations in Canada and work alongside these communities to develop effective assays that directly bridge these diagnostic gaps.

As Canada prioritizes the development of its biomanufacturing and life sciences capacity, the clinical diagnostics framework is paramount to our ability to mount a rapid and effective response to pandemic threats. The research and requested infrastructure in this program will work perfectly in sync to create a framework for producing diagnostic tests suited for various use contexts. Having this highly adaptable technology will enable us to prepare for and quickly react when the next pandemic breaks. The newly developed point-of-care and high-throughput diagnostic assays will offer rapid diagnostic and screening capability, help respond to outbreaks in a timely manner, inform public health interventions, and contribute to the future development of vaccines and therapeutics.

This project aims to support research across all Hubs for vaccine and drug development. All products administered by injection must be aseptically filled into vials to ensure they remain sterile and uncontaminated. This process is known as aseptic fill/finish. COVID-19 highlighted fill/finish bottlenecks contributing to significant delays in the development of new biologics. Scarce fill/finish capacity in Canada forced developers to go outside of our border. Alberta Cell Therapy Manufacturing (ACTM) located at the University of Alberta has existing fill/finish capacity to reduce bottlenecks and ensure Canadians have access to critical vaccines, therapeutics and other life-saving drugs when they need them. The requested infrastructure aids in maintaining and monitoring this aseptic environment, facilitates required quality control testing, accommodates product storage and increases the flexibility of filling container sizes and types.

Operational since 2016, ACTM is a fee-for-service Contract Development and Manufacturing Organization (CDMO) that manufactures products for clinical trials in compliance with Good Manufacturing Practice (GMP) for academic and industry clients across Canada. ACTM is already providing aseptic fill/finish services using a semi-automated system and has purchased a robotic aseptic fill/finish system with the capacity of 4800 vials and pre-filled syringes/day. These fill/finish systems will support all Canadian researchers and industry partners in developing products for clinical trials and ensure that Canada is prepared to respond quickly to the next pandemic. Additional personnel will be trained in this highly specialized field and ACTM is partnered with Hub GMP training programs. Aseptic fill/finish activities must comply with Health Canada’s GMP requirements. The requested infrastructure will support these highly regulated fill/finish activities and ensure ACTM meets current regulatory requirements.

Advanced therapeutics (AT) are a rapidly evolving field of gene- and cell-based therapies which induce and augment natural defenses against disease. For example, mRNA vaccines enable nimble responses to emerging pathogens and engineered immune cells can be used as “living drugs” that sense and respond to a myriad of conditions. At the same time, advances in biomedical engineering and biomanufacturing are creating the instruments, methods, and processes needed to efficiently turn these advanced therapeutic products into effective treatments. We propose the Advanced Therapeutics Manufacturing Facility (ATMF) as a critical infrastructure component supporting research led by Canada's Immuno-Engineering and Biomanufacturing Hub (CIEBH).

The CIEBH ATMF is a state-of-the-art, ~25,300vsq ft good manufacturing practice (GMP) facility located in BC. A ducted air system will control air changes and particle numbers, creating unidirectional air locks in 6 clean rooms. Three clean rooms will support cell production, and one room each will be dedicated to viral vector, plasmid DNA, and mRNA/LNP manufacture. A Quality Control/Analytics Lab will house equipment needed to document product identity, sterility and potency. A Process Development Lab will house equipment needed to scale up and validate processes, as well as train HQP. A suite of equipment will operationalize the facility and enable production of therapies with high potential to solve current and future health challenges, specifically mRNA vaccines, viral vectors and cell and gene therapies.

The BC ATMF will catalyze a leap forward in precision and translational medicine, biomanufacturing, and pandemic preparedness. It is linked with cross-cutting training platforms, offering opportunities for hands on training across a continuum of career trajectories and stages. It enables multiple CIEBH projects and is essential to make Canada a global epicentre for developing next-generation immune-based therapeutics.

Lipid nanoparticle (LNP) messenger RNA technology is now established as a leading approach for development of potent, well tolerated vaccines that can be rapidly developed and scaled at reasonable cost. LNP RNA is poised to play a lead role in combatting future pandemics and can be used to tackle health threats emerging right now, such as antimicrobial resistant (AMR) bacteria. While revolutionary, there is huge space for improving and customizing LNP formulations for vaccine specific purposes.The goal of AVENGER is to establish domestic capacity for a 100-day response to a pandemic pathogen with next-generation LNP RNA technology while establishing R&D and biomanufacturing pipelines that can be used for the development and manufacture of AMR bacterial pathogen vaccines.

AVENGER aims to be Canada’s LNP RNA vaccine platform by developing a library of optimized LNP formulations designed to generate long-lasting immunity to viruses or AMR bacteria, which have very different immune requirements. LNPs are unique in their modular composition, allowing purpose-customized formulation development. We will develop lipid compositions and RNA cargoes tailored to specific pathogen types to create a validated library of LNP vaccine formulations for rapid deployment in the event of an outbreak, slashing required development time. As a demonstration of platform utility, a vaccine to an AMR bacteria will be developed to a Phase-1 clinical trial ready status.

This proposal is led by Pieter Cullis, who has over 40 years of experience in LNP systems and provided key contributions to the Pfizer/BioNTech COVID-19 mRNA vaccine, and Anna Blakney, a self-amplifying RNA (saRNA) vaccine expert who has contributed to clinical vaccine development. The team includes world-class immunologists, vaccinologists, biochemists, and microbiologists intimately connected with world leading LNP industry partners and a track record consistent with the ability to produce a vaccine product in 100 days.

To ensure that Canada is better prepared for the next pandemic, we propose PROGENITER, a project that will be a keystone component of Canada’s Immuno-Engineering and Biomanufacturing Hub (CIEBH). PROGENITER will enable the rapid design, engineering, and production of antibody leads against present and future viral diseases to advance at least three antibodies into IND-enabling studies within four years. PROGENITER’s end-to-end process will span a comprehensive suite of capabilities: including AI-enabled antibody discovery supported by state-of-the-art infrastructure for expression, purification, biophysical characterization, atomic-resolution cryo-EM analysis, and GMP-level production of antibody therapeutics. This mission aligns with CIEBH’s vision for rapidly responding to new threats, and with Canada’s national pandemic preparedness strategy (BLSS).

Drawing on the academic success of its team members during COVID-19, PROGENITER will also broadly connect CIEBH's four pillars. Its infrastructure is capable of supporting next-gen delivery of lipid nanoparticle-based vaccines (P1); engineering antibody technologies (P2); developing T-cell based therapeutics (P3); and driving drug design to address antimicrobial resistance (P4). PROGENITER will leverage its collective expertise to pursue a research program to discover critical pathogen-host protein interactions to identify biologics for current and prospective disease threats.

PROGENITER’s partnership with industry (AbCellera, Amgen, Gandeeva, GSK and Zymeworks) brings a highly innovative and entrepreneurial approach to industrialized discovery, development, and delivery of biologics, with the potential to improve the success rate of therapies in clinical trials. The highly interdisciplinary and diverse team that the project brings together will be vertically integrated for seamless collaboration and focused on the central mission of developing clinical-grade antibodies capable of combatting pandemic threats.

The global response to COVID-19 highlighted challenges tied to misinformation, disparities in access to vaccines, and public perception of risk and scientific uncertainty. The aim of this project is to strengthen public trust in, and access to, safe and effective vaccines and other immune-based innovations as a critical part of Canada's rapid response to future pandemics. We propose the creation of a new, national and multidisciplinary Social Sciences and Humanities (SSH) Consortium of leading scholars, partners and collaborators, all of whom have a proven track record of translating research into practical applications and policies in the real world. The team will build a solid foundation of trust by proactively identifying and mitigating potential social and behavioral obstacles. Project activities are structured into 3 workstreams and 6 objectives, with design and methodologies focused on end-to-end reach (therapeutic pipeline and immunization system), risk analysis (proactive mitigation of threats), and participatory action (engage with diverse groups to co-create knowledge and solutions to barriers). Our methodologies combine quantitative and qualitative methods to support a diverse range of stakeholders: scientists, regulators, public health authorities, health workers, industry, and crucially, the general public, with special emphasis on vulnerable populations. We will bridge the gap between biomanufacturing science and society, uncovering essential SSH evidence and insights that directly inform policy and practice, and training the next generation of health researchers and biomanufacturing experts. We will help cultivate a preparedness that ensures rapid, effective deployment of life-saving innovations during potential future pandemics under Canada’s Biomanufacturing and Life Sciences Strategy.