Biodextris

The importance of technical oversight (CMC) in drug development

The Website Store • Feb 28, 2022

The area of drug development is a veritable minefield with many junctures where a project can come to an abrupt end. The early discovery period presents its own significant challenges, but once a client has selected their lead candidate many organizations feel the heavy lifting is over, however this simply isn’t the case. The next steps of plotting out a clinical manufacturing process paired with analytics to characterize the product, and the inherent regulatory considerations are a very involved and complicated process.

The CMC SME : a key role to acceptance and patient safety

Enter the Chemistry, Manufacturing and Controls Subject Matter Expert (CMC SME) for the purpose of technical oversight. The direction of the CMC program will vary, but generally either an expert is hired-on full time as a staff member, contracted as a consultant, or in some cases an additional service provided by some CDMOs (contract development and manufacturing organization). In any case, the expertise the CMC SME brings to the table is the practical experience of navigating through government regulatory bodies (like FDA or Health Canada) ensuring that the program is well positioned for acceptance, and that patient safety is considered at every step leading to GMP manufacturing. This process may sound simple but there is a plethora of variables to consider from the practicality of scale-up and processing technologies to the overall costs predicted at the end of the process. While balancing these considerations as part of technical oversight, the CMC SME also has to operate within an assigned budget for all these activities and on a timeline that is reasonable for the company.

Terrence Cochrane, President of BrevisRefero Corporation (a Canadian biologics CMC consultancy) shares some of his experiences over the past 22 years to further illustrate the importance of having expert guidance and technical oversight:

“It can be challenging when there is the realization of a CMC experience gap within the organization, which can result in directional program changes once a CMC SME joins after activities have already started. As a result, the client has spent time, money and resources on activities that may require partial or full redirection, but it also affects the CDMO they’re engage with, in that the repeat (or start-over) of work can cause significant delays in moving the client’s product into GMP manufacturing. What I typically recommend to early-stage companies moving their product into clinical development is to perform an inventory of the technical CMC capabilities of the organization, such as process or analytical development experience, or scale-up and GMP manufacturing track-record. From there, management can evaluate the organizational skillset in comparison to the demands of the CMC program to determine whether the existing organization could possibly be augmented by an external CMC SME. While the thought of engaging an external SME can seem like a daunting task, the reality is that CMC SME’s (such as those at BrevisRefero) are used to being thrown into a fast-paced and dynamic CMC environment with many internal stakeholders, and they can typically come up to speed quickly for the benefit of both the client and drug development program. At the end of the day, speed to first-in-human studies is a top priority, and neglecting the important aspect of CMC experience can cause significant delays or even failure. In one recent project I observed a 9-month delay due to having to start over in critical areas of the CMC program, and in another program from a couple years ago a 6-month delay. This can cause real harm to the timelines while the technical program is sorted out, not to mention the inevitable shaking of board of director and investor confidence in the organizations’ ability to deliver.”

How technical oversight and CMC complements CDMO services:

Time and money are the two most critical factors in any business’ success and as illustrated above, expert guidance in drug development will yield a return on investment by saving both. Of course, complementary to expert guidance and technical oversight, a comprehensive service provider like the Clean Biologics family of companies is also imperative to support product development for a successful drug launch. The Clean Biologics family collectively offers quality control, biological safety tests for biopharmaceutical products for regulatory compliance, production of cell banks /GMP-grade BSL2/BSL3 virus seed stock; also offering CDMO services in both GMP and non-GMP with both microbial, viral and cell-based platforms along with the full complement of GMP analytical testing and development in the areas of vaccine, antibodies, oncolytic viruses and viral vectors.

Editorial by John Mukherjee – Director of Business Development and Marketing at Biodextris Inc. Terrance Cochrane can be reached at t.c@brevisrefero.com; BrevisRefero Corp. is a consultancy offering a comprehensive suite of CMC related services.

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Accelerating Success and Reducing Costs: The Impact of Quality by Design in Complex Biologics Development

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.

A project-based approach to biologics CDMO collaboration

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.

Calder Biosciences announces clinical supply agreement with Biodextris to evaluate its lead RSV vaccine candidate as part of a Phase 1 clinical trial

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.