Biodextris Inc. inaugure ses nouvelles installations en plein cœur de la Cité de la Biotech à Laval

Quebec City, December 17th, 2024 – Aramis Biotechnologies Inc. ("Aramis"), a Quebec City-based company specialized in plant-based biomanufacturing of innovative vaccines, and Biodextris Inc. (“Biodextris”), a Montreal-based CDMO specialized in cGMP complex biologic products, are excited to announce the signature of an agreement. This strategic partnership will leverage the expertise of both companies to ensure efficient downstream manufacturing of clinical materials for Aramis’ leading product candidate, a seasonal influenza vaccine with the potential to improve the protection of at-risk populations. Under the terms of the agreement, Biodextris will provide Aramis with access to its state-of-the-art facilities and industry-leading capabilities to ensure the timely production of high-quality materials for Aramis’ forthcoming Phase 1 & 2 clinical trials. The downstream manufacturing agreement marks an important milestone in the ongoing collaboration between Aramis and Biodextris, combining cutting-edge science and manufacturing excellence to drive success in clinical development. "We are delighted to be working with Biodextris as partner for downstream manufacturing and supply of clinical material" said Aramis’ Co-founder & CEO, Frédéric Ors. "This partnership is aligned with Aramis’ business model to use the best external expertise and capabilities, and prepare operations scale-up for potential pandemic response. From the initial proposal through to the extensive collaboration to date, we’ve been impressed by Biodextris’ partnership-centric approach to identifying and solving technical challenges, as well as their commitment to the highest quality standards, making them an ideal partner for clinical-scale production of our influenza vaccine candidate.” "It’s a pleasure to be chosen as Aramis’ development and downstream manufacturing partner in their mission to revolutionize vaccines” says Cédric Héroux, Biodextris’ GM. “The Aramis team’s deep scientific expertise and passion for health impact, both in Canada and at a global level, has resonated deeply with Biodextris since the start of our collaboration, and we look forward to working with them to make these vaccines accessible to patients.” About Aramis Biotechnologies Based in Quebec City, Aramis Biotechnologies is a Canadian company founded in 2023 that specializes in plant-based production of innovative vaccines. As a majority employee-owned company, our ambition is to develop innovative and sustainable solutions to current and future public health challenges. The Aramis’ team is grateful for the support from Innovation, Sciences and Economic Development Canada and from the City of Quebec. About Biodextris Inc. Biodextris is a cGMP complex biologics CDMO with over 20 years’ experience in the development, GMP manufacturing, and bioanalysis of high-value complex biologic products. With customers ranging from the largest global Biopharmaceutical companies to university spin-outs, Biodextris is the partner of choice for innovative Biotechnology companies with novel or complex processes looking to accelerate their path to clinic & commercialization. Biodextris’ new center of excellence in Laval, supporting customers in manufacturing and analysis from pre-clinical development through to commercialization, was developed with the support of the governments of Quebec and Canada, as well as Investissement Québec. For more information: aramisbiotechnologies.com biodextris.com

Québec, le 17 décembre 2024 - Aramis Biotechnologies Inc. (« Aramis »), une entreprise de Québec spécialisée dans la production de vaccins innovants produits dans les plantes, et Biodextris Inc. (« Biodextris »), un CDMO de Montréal spécialisé dans les produits biologiques complexes conformes aux BPF, sont heureux d'annoncer la signature d'une entente. Ce partenariat stratégique s'appuiera sur l'expertise des deux sociétés pour assurer une fabrication en aval efficace du matériel clinique pour le produit candidat principal d'Aramis, un vaccin contre la grippe saisonnière ayant le potentiel d'améliorer la protection des populations à risque. Selon les termes de l'accord, Biodextris fournira à Aramis l'accès à ses installations de pointe et à ses capacités industrielles de premier plan afin d'assurer la production en temps voulu de matériel de haute qualité pour les prochains essais cliniques de phase 1 et 2 d'Aramis. L'accord de fabrication en aval marque une étape importante dans la collaboration en cours entre Aramis et Biodextris, combinant science de pointe et excellence de la production pour assurer le succès du développement clinique. « Nous sommes ravis de travailler avec Biodextris en tant que partenaire pour la fabrication en aval et l’approvisionnement de matériel clinique », a déclaré Frédéric Ors, cofondateur et chef de la direction d'Aramis. « Ce partenariat s'inscrit dans le modèle d’affaires d'Aramis, qui consiste à utiliser les meilleures compétences et capacités externes, et à préparer la mise à l’échelle des opérations en vue d'une éventuelle réponse à une pandémie. Depuis la proposition initiale jusqu'à la collaboration approfondie à ce jour, nous avons été impressionnés par l'approche centrée sur le partenariat de Biodextris pour identifier et résoudre les défis techniques, ainsi que par son engagement à respecter les normes de qualité les plus élevées, ce qui en fait un partenaire idéal pour la production à l'échelle clinique de notre candidat-vaccin contre la grippe. » « C'est un plaisir d'être choisi comme partenaire d'Aramis pour le développement et la fabrication en aval dans sa mission de révolutionner les vaccins », déclare Cédric Héroux, directeur général de Biodextris. « L'expertise scientifique approfondie de l'équipe d'Aramis et sa passion pour l'impact sur la santé, tant au Canada qu'au niveau mondial, ont trouvé un écho profond auprès de Biodextris depuis le début de notre collaboration, et nous sommes impatients de travailler avec eux pour rendre ces vaccins accessibles aux patients. » À propos d’Aramis Biotechnologies Basée à Québec, Aramis Biotechnologies est une entreprise canadienne fondée en 2023 qui se spécialise dans la production de vaccins innovants produits dans les plantes. En tant qu’entreprise à capital majoritairement détenu par nos employés-actionnaires, notre ambition est de développer des solutions novatrices et durables pour répondre aux défis de santé publique actuels et futurs. L'équipe d'Aramis est reconnaissante du soutien apporté par Innovation, Sciences et Développement économique Canada et par la Ville de Québec. À propos de Biodextris Inc. Biodextris est un CDMO de produits biologiques complexes conformes aux BPF avec plus de 20 ans d'expérience dans le développement, la fabrication BPF et la bioanalyse de produits biologiques complexes de grande valeur. Avec des clients allant des plus grandes sociétés biopharmaceutiques mondiales aux entreprises dérivées d’universités, Biodextris est le partenaire de choix pour les sociétés de biotechnologie innovantes avec des processus nouveaux ou complexes qui cherchent à accélérer leur chemin vers la clinique et la commercialisation. Le nouveau centre d'excellence de Biodextris à Laval, qui soutient les clients dans la fabrication et l'analyse depuis le développement préclinique jusqu'à la commercialisation, a été développé avec le soutien des gouvernements du Québec et du Canada, ainsi que d'Investissement Québec. Pour plus d’informations: aramisbiotechnologies.com biodextris.com

Laval, October 4, 2024 – In the presence of Annie Koutrakis, Member of Parliament for Vimy and Parliamentary Secretary to the Honourable Soraya Martinez Ferrada, Minister of Tourism and Minister responsible for Canada Economic Development Regions for Quebec regions, Christopher Skeete, Minister for the Economy, Minister Responsible for the Fight Against Racism, and Minister Responsible for the Laval Region, and Guylaine Rose, Regional Director for Laval and Outaouais at Investissement Québec, Biodextris Inc. proudly inaugurates its brand new laboratories in the heart of Laval's Biotech City. These new facilities, resulting from nearly $25 million in investments, mark the beginning of a new era for the Quebec-based company specializing in the development, clinical manufacturing, and packaging of vaccines and biologics for biotech and pharmaceutical companies. “We are extremely proud to inaugurate these new facilities. This move represents much more than a simple change of location; it symbolizes our commitment to innovation and our desire to continue growing while remaining true to our customer-focused approach centered on human relationships,” said Cédric Héroux, CEO of Biodextris. Founded in 2015, Biodextris Inc. was the initiative of three entrepreneurial scientists from Quebec. Following the closure of GSK's enterprise and leveraging the company’s legacy, the founders chose to persevere and continue certain operations locally, ensuring the retention of high-quality jobs. Today, Biodextris Inc. employs over 40 people and stands out for its professionalism, personalized customer approach, and expertise in working with complex products. The pandemic, which refocused global attention on biotechnology-based vaccines and treatments, spurred the company's expansion. This growth phase reflects Biodextris' remarkable commitment to excellence and its mission to contribute to the advancement of Quebec’s life sciences industry. Located in the heart of Laval’s Biotech City, the custom-designed facility was built to meet Biodextris’ specific needs. The project received $4 million in support from the ESSOR program, administered by Investissement Québec on behalf of the Government of Quebec, along with an additional $3 million directly from Investissement Québec. Furthermore, the Government of Canada, through CED, is providing $900,000. “Investissement Québec is proud to support companies that strengthen Quebec’s life sciences ecosystem. Biodextris' project illustrates what can be achieved when innovation and growth are at the heart of a company’s mission. This expansion will not only boost the company’s productivity but also address a strategic need within our economy,” said Bicha Ngo, President and CEO of Investissement Québec. These investments will allow Biodextris Inc. to quadruple its production capacity, expanding from 8,000 to 32,000 square feet, and increase its workforce from 44 to 65 employees over the next three to five years. Additionally, this expansion will introduce a new division dedicated to the development and production of clinical batches of biotherapeutics, utilizing messenger RNA and plasmid technologies. “Our government is proud to invest $4 million in Biodextris' cutting-edge new facilities. We will continue to support local companies that help Quebec shine in the life sciences sector,” said Christine Fréchette, Minister of the Economy, Innovation and Energy, and Minister Responsible for Regional Economic Development. “With its high-quality infrastructure and experienced professionals, Biodextris contributes to the vitality of Quebec’s life sciences industry. By supporting the development of their new facilities, we are reinforcing Laval’s role as a hub of innovation in this field,” said Christopher Skeete, Minister for the Economy, Minister Responsible for the Fight Against Racism, and Minister Responsible for the Laval Region. “Our government is committed to investing to ensure our SMEs remain competitive and innovative. Thanks to CED’s support, Biodextris will be able to increase its production capacity, improve its competitiveness and continue to foster innovation in the life sciences field. We are here to support workers and Quebec and Canadian SMEs by helping them equip themselves with what they need so that, together, we can build a stronger, more resilient, more sustainable economy,” stated Annie Koutrakis, Member of Parliament for Vimy and Parliamentary Secretary to the Minister of Tourism and Minister responsible for CED. The opening of Biodextris Inc.’s new facilities not only illustrates the company’s success but also its ongoing commitment to innovation and excellence in life sciences, showcasing Quebec’s supportive environment for the development of such enterprises. “The inauguration of Biodextris Inc.’s new facilities in Laval is a source of pride for our city. It underscores our commitment to supporting innovation and economic development in the life sciences sector. We are thrilled to welcome this important expansion, which further strengthens our position as a leading Biotech City,” said Stéphane Boyer, Mayor of Laval. About Biodextris Inc. Founded in 2015, Biodextris Inc. is a subsidiary of Clean Biologics SAS, which provides clinical manufacturing process analysis and development services and quality control testing for clients in the vaccine and biologics industries. The company is staffed by experienced biologics development scientists, and key team members have worked together in medium and large vaccine development and manufacturing companies for almost twenty years. The Biodextris team provides its extensive pharmaceutical company expertise in a more personal and interactive setting to clients of various sizes. The company develops, manufactures, and tests a wide range of biological products for vaccine, pharmaceutical, and other applications. Biodextris has the experience and expertise to develop high-quality, robust, and marketable products, while acting with the flexibility and sense of urgency required by small organizations.

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In the realm of complex biologics development, the integration of Quality by Design (QbD) not only assures product quality but also emerges as a powerful driver for cost reduction and accelerated timelines. A systematic approach to development in biopharma, it emphasizes the integration of quality evaluation at every step, ensuring the production of safer and more effective drugs while optimizing resources. Unlike traditional post-production testing, Quality by Design proactively identifies and adjusts critical parameters and factors involved in development. This brief discussion explores the pivotal role of QbD in achieving these dual objectives. Determining quality target product profile and critical quality attribute is a key to a successful and efficient development. It is important to define quality target product profile (QTPP) and critical quality attributes (CQA) of the product as soon as possible during the development stage. If well defined, the Quality by Design approach will help address issues early in the product development process and prevent failures than will lead to additional cost and delay during advanced stages of the project. At Biodextris, we encourage and guide our client through Quality by Design process to ensure quality, cost optimization and timeline efficiency. Efficiency through Attribute Optimization and precise process control: Quality by Design enables a targeted optimization of critical product quality attributes, streamlining development efforts and reducing the need for extensive trial and error. By enhancing process understanding and control, QbD minimizes variations and deviations in complex biologics production. This precision and efficiency not only ensure consistent product quality but also accelerates the development timeline by avoiding delays associated with troubleshooting and rework. Risk Mitigation for Cost-Efficient Development: Quality by Design systematically identifies and mitigates risks early in the development process. This proactive risk management not only safeguards against potential setbacks but also contributes to cost efficiency by preventing the need for costly corrections later in the development cycle. Regulatory Compliance for Timely Approvals and Adaptability for Faster Life Cycle Management Well defined QbD attributes aligns with regulatory expectations, ensuring that the development process is well-documented and compliant. This adherence expedites regulatory approvals, reducing the time and resources required for navigating the approval process. Furthermore, Quality by Design's emphasis on continuous improvement allows for swift adaptation to changes throughout the product's life cycle. This adaptability reduces the time and costs associated with implementing updates or modifications post-launch. For Biodextris, Quality by Design is not only a quality assurance framework but also a strategic ally for reducing costs and accelerating timelines in the development of complex biologics as well as decrease regulatory compliance risks by building product knowledge and understanding. Its systematic approach, from attribute optimization to risk mitigation and formulation efficiency, positions QbD as an indispensable tool for achieving cost-effective and timely success in the competitive landscape of all biologic products development, especially for Complex Biologics. Contact us to see how Biodextris and Quality by Design can help you bring your innovation to life and follow our next newsletters for more details the QbD tools we use to improve your projects.