Biodextris

Bringing innovation to life

A trusted partner with decades of experience, Biodextris develops, manufactures and tests a wide range of biologics products. Whether it’s a vaccine, biologic, or other product, Biodextris will help you bring your innovation to life.

Analytical

We cover a wide array of biologic and small molecule products

Development

Production processes ready for manufacturing.

Bioproduction

We have extensive experience in manufacturing proteins.

About Biodextris

The Biodextris Team has worked together in mid and large sized vaccine companies for the past 18 years, now offering our big pharma expertise in a more personal and interactive package. We develop, manufacture and test a wide range of biologic products for vaccine, pharmaceutical and other applications.

Providing High Quality Clinical Development

The Way a CDMO should be

One-stop Partner

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

Extensive Vaccines And Biologics Experience

Dedicated Project Managers

Comprehensive Analytical Services

Collaborative With Regular Feedback

Development Strategy Input

CGMP Manufacturing Suite

Book an Appointment

We offer a full array of cell based production for Biological products.

With Biodextris, your project is overseen by dedicated project managers with extensive hands-on experience, saving you time and enhancing your experience. We offer technical and quality guidance, with cGMP compliant testing to ensure you successfully navigate the regulatory path for your product.

Proteins

Enzymes

Antibodies

Biosimilars

Peptides

Plasmids

Our services

Companies can rely on the Biodextris Team to deliver excellent services for a wide range of biologic products.

Our history leaves us with the know-how for high quality, robust, commercial product development combined with flexibility and the sense of urgency inherent in smaller organizations. From Analytical Development to Quality Management, our team of experienced product development scientists will get you through your project.

Analytical Services

Skilled experts in developing complete analytical packages for novel and complex vaccines, biologics and small molecules.


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Development Services

Rapid delivery of robust and reliable production processes ready for manufacturing of your vaccine or biologic.

Upstream Process

Downstream Purification

Process Transfer


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Bioproduction Services

Production services provide high-quality cGMP material for research, preclinical or clinical investigations.

Quality Documentation And Characterization Packages

Bl2 Production Capabilities

Glp Toxicology Lots


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Your Health And Safety Is Important To Us

Get in Touch With Us

Drop us a Message

Please feel welcome to contact our friendly reception staff with any enquiry. We will answer to you shortly!

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Recent Articles

Tips, News and Updates

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
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