News & Events

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

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.

Discover Biodextris' new cGMP biomanufacturing and analytical facility. Check out our state-of-the-art capabilities.

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.

In the landscape of the biopharmaceutical industry, the partnership between a biopharma sponsor and its biologics Contract Development and Manufacturing Organization (biologics CDMO) has become more than a simple business arrangement and has transformed into a strategic collaboration characterized by flexibility and adaptability. Historically, biopharma companies have had to contract very large projects out to biologics CDMO meaning they would commit large financial and organisational resources, which did not always match investment cycles. Today, the industry and its biopharma CDMOs are recognizing the benefits of segmenting projects and costs, aligning them with funding phases and thus optimizing resources while fostering innovation. Biodextris: at the heart of a multi-expertise CDMO organization With extensive development and manufacturing capacities, biologics CDMO Biodextris has accompanied this change with strong, project-based partnerships with the biopharma industry. As part of the Clean Biologics group , Biodextris is also at the heart of a multi-expertise organization, thus enhancing the capacity to coordinate overall biopharma CDMO capacities while keeping a segmented approach. Aligning organisational resources with funding cycles to mitigate risk and foster innovation Biopharma projects typically go through several funding cycles, covering discovery and R&D, clinical trials and commercialization, and which require support from biopharma CDMOs and CROs. This includes sometimes long analytical, development and biomanufacturing phases requiring a sizable financial commitment. A flexible approach to biologics CDMO collaboration aligns costs with these funding phases ensuring that financial resources are used efficiently. Additionally, this strategy contributes to overall risk mitigation: the development cycle of a biopharma substance is rife with uncertainties, including regulatory changes, market dynamics, and technical advancements. Flexibility in biologics CDMO partnerships allows biopharma companies to adapt to these pitfalls and hurdles more efficiently. With a keen understanding of the biopharma dynamics and its privileged position within a biologics CDMO group, Biodextris optimizes resources for sponsors by reducing organisational burdens: this leaves our partners with more time and resources for their core and strategic activities including discovery, R&D and business development.

Boston, MA, June 5, 2023 (GLOBE NEWSWIRE) – Calder Biosciences Inc., a molecular engineering and clinical manufacturing-stage biotechnology company pioneering its 3D-Vaxlockä platform technology to engineer and develop novel protein subunit vaccines, today announced a clinical supply agreement with Biodextris Inc. Under the agreement, Calder Biosciences will evaluate DT-preF, its lead candidate in the development of a vaccine to prevent acute lower respiratory infections caused by the Respiratory Syncytial Virus (RSV), as part of a Phase I clinical trial that will include an efficacy read-out. Preclinical studies are designed to assess the toxicity and tolerability of the lead candidate vaccine. The preclinical study will begin in Nov and the Phase 1 clinical study will begin in H1 2024. Calder Biosciences’ CEO, Chris Marshall, remarks: “We are truly excited to be working with the Biodextris team to bring our RSV vaccine candidate into production, featuring our novel manufacturing process. This represents the first of a series of conformationally locked protein subunit vaccines with greatly improved safety and potency.” "We are delighted to have signed this agreement with Calder Biosciences. It represents an important contract for Biodextris, as this work will be the first to be carried out by our production and development teams in our new industrial-scale vaccine and biologics development, manufacturing and packaging plant (CDMO)” says Alain Carrier, General Manager of Biodextris. The new Biodextris biomanufacturing centre (cGMP) and its analytical capabilities was developed with the support of the governments of Quebec and Canada and Investissement Québec. Today's announcement was made at the 2023 BIO International Convention, which is being held in Boston, MA, from June 5 to 8. About Biodextris Inc. Founded in 2015, Biodextris 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. About Calder Biosciences Inc. Founded in 2018, Calder Biosciences is a New York City-based, privately held, clinical manufacturing-stage biotechnology company with financial backing from SOSV, a global venture capital firm. Calder is developing next-generation protein subunit vaccines. Calder’s proprietary 3D-Vaxlockä technology locks proteins in the conformation that most prominently exposes sites of vulnerability and elicits substantially amplified and focused, neutralizing antibody responses, along with strong T cell responses. These responses are expected to improve both protection and safety. Better stability also substantially reduces cold chain requirements and spoilage. Calder’s lead, 3D-Vaxlock’d RSV vaccine is entering clinical development. For more information: www.calderbiosciences.com www.biodextris.com

We are proud to announce that Biodextris has commissioned a dedicated 30,000 sq.ft. custom-designed cGMP biomanufacturing facility including development and analytical capabilities to cater to growing demands. The bioprocessing building includes: 6,000 sq.ft. segregated cGMP biomanufacturing suites 2,500 sq.ft. controlled material warehousing 8,000 sq.ft. process development and analytical / QC laboratories Biodextris is well known for its agility and the increase in available cGMP bioproduction suites will allow us to continue to adapt to our growing customer needs. Our production capacity will be expanded by the addition of 200L bioreactors as well as aseptic filling capacity . The new analytical/QC laboratory will benefit from the addition of new equipment to support the increasing number of techniques performed internally as well as to ensure that the latest technologies are available to Biodextris clients. This investment in cGMP biomanufacturing infrastructure and analytical capabilities is a key element of our strategy. It supports our mission as a CDMO to bring innovation to life , by offering our partners and client a facility capable of carrying their projects from early clinical phases to commercial production. This extension of capabilities is also an integral part of the strategy of the Clean Biologics group to propose integrated CDMO services for biopharma sponsors. The newly constructed analytical laboratories and cGMP bioprocessing facility is located in the Cité de la Biotech Laval and is set to be ready for operation during the summer of 2023. Please reach out to the team for additional information.

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