Biodextris

Biodextris Dans Biotech Finances

The Website Store • Oct 25, 2016

Biodextris cherche 1 à 3,5 M€

La CRO canadienne basée à Laval, lancée en septembre 2015 par Christine Jacques, Paul Rice et Joseph Zimmerman, entend profiter de sa future levée auprès d’investisseurs canadiens pour augmenter sa capacité de production, diminuer ses coûts d’opération par employé et bâtir une usine de fabrication de lots cliniques. Ex-chercheurs seniors de l’unité nord-américaine principale de GSK-Vaccins, les trois fondateurs ont profité de la fermeture du centre de recherche de cette big pharma à Laval, cédé par la suite à Néomed, pour s’émanciper et se lancer dans l’aventure entrepreneuriale.


Ils ont pu obtenir quelques aides remboursables, 173 k€ venant de la ville de Laval et de la Banque de développement du Canada, qui leur ont permis de démarrer dans les locaux mêmes du centre de recherche. « La situation était avantageuse pour nous, car nous disposions des équipements avec lesquels nous avions l’habitude de travailler chez notre précédent employeur », précise Christine Jacques, directrice des services analytiques chez Biodextris. « Nous étions immédiatement opérationnels, avec une excellente expertise et, très vite, nous avons décroché un client important à l’international dont nous ne pouvons divulguer le nom. Désormais, après un peu plus d’un an d’existence, il nous est nécessaire d’élargir le spectre de notre activité ». Concrètement, l’entreprise, qui a bouclé son premier exercice en engrangeant 690 k€ de chiffre d’affaires, est à la recherche d’un site pouvant accueillir une usine de production de lots cliniques de produits biologiques. Elle emploie d’ores et déjà dix salariés et pense en recruter six autres prochainement. « Les CRO basées au Canada qui offrent les services tels que les nôtres n’étant pas très nombreuses, nous y avons vu une opportunité de croissance », explique Christine Jacques à propos de sa montée en puissance rapide.

“L’expérience GSK pour servir autant

la grosse pharma que les petites biotech.”

L’expertise qui fait la différence

Au Québec, Biodextris reste, semble-t-il, protégée en raison de son expertise. Les trois fondateurs ont en effet développé des douzaines de produits pour des essais cliniques en phases early à destination des marchés canadiens, états-uniens et européens. « Avec cette expérience héritée de GSK, nous savons ce qu’il faut pour amener un produit en phase clinique et comprenons très bien les situations, autant pour les big pharma que pour les petites biotech. Notre service consiste à accompagner et conseiller le client pour développer un procédé de fabrication robuste et fiable incluant la fermentation, la purification et la formulation, pas seulement à réaliser des tests », souligne Christine Jacques. La moitié des activités de la CRO est consacrée au contrôle qualité des produits biologiques durant toute la durée des études cliniques. La prochaine étape pour Biodextris consistera à percer le marché américain en priorité et à réagir aux opportunités qui se présenteront à l’international, notamment en Chine. Il faudra pour cela réussir le round de financement qui est en cours.


Opinion de Jean-Marc Juteau, directeur de la Cité de la Biotech (Québec)

Il y a un an, alors que plusieurs chercheurs et entreprises présentaient leurs projets afin de démarrer une spin-off dans les anciens locaux de GSK et s’installer chez Néomed, l’équipe des fondateurs de Biodextris en avait déposé l’un des meilleurs. Plusieurs partenaires du développement économique, lors des réunions d’évaluation, ont immédiatement soulevé la qualité de sa candidature. Depuis octobre 2015, il s’agit définitivement de l’une des compagnies de ce lot qui a le mieux réussi. Les trois chercheurs-fondateurs ont pu collecter les aides financières nécessaires, des contrats avec des clients importants et à offrir un ensemble de services leur permettant d’aller chercher des revenus très intéressants sur le court terme. Les fondateurs sont très complémentaires, ayant des expertises indéniables en laboratoire ainsi que pour le développement des affaires. Avec leur vision commerciale, leur plan d’affaires clair, il ne fait aucun doute qu’ils trouveront les fonds nécessaires pour le financement de leur expansion ainsi que pour l’obtention de nouveaux contrats.


173 k€
C’est le montant obtenu par Biodextris sous forme de prêts de la ville de Laval et de la Banque de développement du Canada, pour son démarrage. La société, avec 690 k€ de chiffre d’affaires, cherche à lever 1 à 3,5 M€ pour son expansion.


73 Md€
C’est le montant du marché global, estimé pour 2019, du contrat pharmaceutique de la fabrication en sous-traitance, qui croît à un taux annuel moyen de 7,5 % depuis 2013, alors à 50 Md€.


75 %
C’est le pourcentage des 600 cadres questionnés de compagnies pharmaceutiques et biotech cherchant à sous-traiter, et qui s’attendent à augmenter leurs dépenses en services contractuels recherche et fabrication au cours des cinq prochaines années, selon un sondage réalisé par Visiongain en février 2015.


Article publié dans Biotechfinances • Lundi 24 octobre 2016 • No 742

Biodextris - Bringing Innovation to Life

With Biodextris, your project is overseen by dedicated project managers with extensive hands-on experience, saving you time and enhancing your experience.


Learn more about us ➜

Leave A Comment

Search

Recent Posts

16 Feb, 2024
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.
24 Oct, 2023
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.
By Cedric Heroux 06 Jun, 2023
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
Biodextris commissions a custom-designed cGMP biomanufacturing and analytical facility
By The Website Store 14 Sep, 2022
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.
Is cell culture to replace microbial fermentation?
By The Website Store 13 May, 2022
Is cell culture to replace microbial fermentation in the biologics arena ?
Why is process development such a lengthy activity?
By The Website Store 18 Mar, 2022
Why is Process Development such a lengthy activity?
More Posts

Share Posts

Share by: