CER Groupe: Advanced Biologics and Reagents Solutions for Sustainable Diagnostic Industry

In the rapidly evolving field of diagnostics, reliable and reproducible reagents are vital for accurate and effective testing. At CER Groupe, we are committed to supplying the diagnostic industry with high-quality and sustainable biologics and reagents, empowering companies to achieve success in their diagnostic endeavors, now and in the future. With a mission to provide game-changing solutions meeting current and future challenges, we understand the critical role played by diagnostic reagents in driving advancements in healthcare and commit to support innovation through significant investment in research and development.

In Vitro Diagnostic Trends and Challenges

The in vitro diagnostic industry is witnessing significant trends and challenges that demand careful consideration. On one hand, with the ever-growing demand for rationalized medication (e.g. for antibiotics), personalized medicine (e.g. oncology, auto-immunity) point-of-care, self-testing devices, and the increasing prevalence of diseases, diagnostic companies face the pressure to develop flexible platform delivering fast, robust and reliable results, with a significant multiplexing and automation potential. Results acquisition, analysis, interpretation and communication to health professionals is becoming a general trend also, with many digital health and connected diagnostic innovations. On the other hand, there is also an emergency in developing new diagnostic technologies that meet the sustainability challenges faced by an industry using significant amounts of biohazard waste containing plastic and chemical reagents difficult to recycle and manage. To complete this high-level picture of current industry challenges, the implementation of regulatory frameworks, such as the In Vitro Diagnostic Regulation (IVDR), drastically strengthen the requirements during the development, validation and routine manufacturing of in vitro diagnostic.

All these trends are tightly linked to the diagnostic reagents used in these IVD products, further emphasizing the importance of choosing the right partner for development and routine supply of diagnostic reagents, today and for the future. Quality, compliance, and expertise become paramount in ensuring diagnostic reliability and sustainability.

CER Groupe: Your Solution for Diagnostic Excellence

As a provider of best-in-class diagnostic reagents, CER Groupe offers a comprehensive range of services to support the diagnostic industry throughout the research, development, and routine supply phases of the product lifecycle. With an uninterrupted ISO9001 quality management system since 1995 and the consideration of P4EU and ARBRE-MOBIEU QC sequence principles to secure biologic development, CER Groupe established robust processes and continuously implement technological improvements for biologic and reagent development and production. Our commitment to excellence and customer satisfaction sets us apart as a reliable partner for decades both for animal and human diagnostic innovation programs.

Research and Development of Diagnostic Biologics

CER Groupe provides a wide array of services to facilitate the research and development of diagnostic biologics. Starting from the target and the ultimate application, our expert team combining > 100 years of cumulated experience in antibody and protein production offers tailored approaches to reach project objectives and timelines. Our expertise includes hapten synthesis, recombinant production, and the generation of high-sensitivity reagents such as mAbs, pAbs and VHH (mouse, rabbit, lama, …) with >100.000 programs completed so far. More recently, to improve performance of biologics, we integrated new computational approaches for rational design of biologics that fasten protein engineering processes.Whatever you are looking for a protein stable in challenging pH or temperature conditions or for an antibody with a modulated affinity, artificial intelligence can already help save time and money by scoring potential candidates, helping researchers take the good decision and keep R&D budget on track.

Recombinant protein production is performed in E. coli and mammalian cells, the host system and subtype being proposed based on final application, protein nature and preliminary technical study. Our team of experts also advice on cost-effective production/purification strategy and propose clear milestones, guarantees and timelines, in total transparency. The reagent cost being always an important factor to ensure diagnostic product profitability, licenses for high-producing strains achieving up to > 1 g/l were acquired, enabling us to offer competitive routine manufacturing packages without impacting product quality.

We also invested in state-of-the-art technologies for antibody development, like DNA immunization and B cell sequencing to tackle challenging targets, resulting in more relevant candidates and ultimately the selection of game-changer antibodies. Through these approaches, we maximize probabilities to obtain highly specific and sensitive diagnostic tools overpassing requirements.

Developing best-in-class biologics is part of our commitment in supporting a more sustainable diagnostic industry, through reduced development timelines, the use of lower quantities of reagents, and also the supply of more efficient and stable biologics. From a more general point of view, research programs are continuously led with regional and international academic actors to develop innovative diagnostic technologies all along the value chain for the future: biologic development, support functionalization, sample preparation, target detection, results acquisition/analysis and new diagnostic platform. Contact us to learn more about our research topics for diagnostic industry.

Product Development and Stabilization

We understand the importance of stability and formulation in diagnostic product development. Thanks to its expert biochemist team, CER Groupe enhances the performance and stability of diagnostic reagents through advanced conjugation techniques, including site-specific conjugation of enzymes, fluorophores or supports like magnetic beads. Additionally, our custom formulation platform is available for freeze-drying process setup and stable formulation optimization services, ensuring the long-term viability and reliability of diagnostic products through a fine understanding of their critical parameters. Beyond the insurance of proposing robust diagnostic products, product optimization also enable to emphasize the technological transfer of assays from widely used platform such as ELISA to modern technologies. The sustainable future of diagnostic will use microfluidic, label-free, high-plex, low-waste, cheap and highly sensitive biosensing platform like biolayer interferometry (BLI), surface-plasmon resonance (SPR) or photonic integrated circuits. For these advanced platforms, biologic quality requirements are strengthened, justifying the investment in characterizing more integrity attributes and in optimizing product conjugation or formulation.

Analytical Capabilities for Quality Control

How to efficiently and rationally optimize a product if relevant information is not available? Not easy! CER Groupe's state-of-the-art analytical capabilities enable the thorough characterization of key reagents and the identification of critical quality attributes. Next to usual screening techniques for purity and quantity assessment, we utilize label-free molecular interaction analysis technology to screen engineered candidates and select optimal reagents and conditions for assays without pre-labeling requirements. Proteomic analysis allows us to assess molecular attributes, such as antibody glycosylation or conjugate degree of labeling, and to evaluate their impact on antigenicity. Structural characterization is also offered to learn more about product homogeneity, integrity, stability, … all these data being integrated to optimize formulation and storage conditions. This comprehensive understanding of critical quality attributes enables us to implement effective quality control techniques and proactively monitor product reproducibility, rationally. Sustainability is also about selecting the right package of QC assays that is sufficient to assess product quality regarding the final application without performing extensive and often useless range of quality controls.

Routine manufacturing and supply of diagnostic products

The most important criteria when choosing a partner for routine supply are of course the service price but also the product quality, the contact easiness, the reproducibility, the respect of timelines, the access to traceability information, the documentation quality, the efficiency of logistic practices, and the partner independency.

By choosing CER Groupe as your partner for routine supply, you benefit from all these advantages. Our state-of-the-art facilities are completely qualified and organized to meet rapid and flexible requests from our partners. Through our multiple bioreactors, we can propose batch size aligned with your requirements at competitive prices. Our ambition is to leverage our strengths to consolidate our position of reference supplier for diagnostic companies in Europe.

With a long-lasting experience of multi-year service agreement with large companies, you can rely on us for your protein and antibody portfolio management.

Experience Transformative Collaboration

Partnering with an independent structure like CER Groupe offers several advantages for diagnostic companies.

• Clear contact point for your business and technical requests and regular follow-up
• More than a partner, CER Groupe is also a reference center for innovation, and is already involved in new technology development for diagnostic industry through international collaborations
• We combine expertise in both production and characterization, ensuring a seamless integration of research and routine manufacturing
• Operating under strict quality standards, we provide reliable and reproducible diagnostic reagents, without claiming any IP on your products
• Located in Belgium, our strong logistic practices enable efficient global distribution
• Our flexible production scale is tailored to meet the specific needs of the diagnostic industry, while offering competitive pricing without compromising quality
• Trust of our partners is of paramount importance, we are very strict regarding confidential information management and commit to offer the best practices for data integrity management

Conclusion

CER Groupe is your trusted partner in the diagnostic industry, dedicated to supplying high-quality biologics and reagents for today and for the future. With our comprehensive range of services, including research and development, routine manufacturing, and advanced analytical capabilities, we empower diagnostic companies to achieve their objectives, ensure reliable testing, and meet sustainability requirements. More than a subcontractor, CER Groupe is your partner for innovation, and develop long-term and trust relationship with its partners.

We invite you to contact us today to discuss your innovation program and challenge our solutions. Experience the transparency, expertise, and competitive advantages that CER Groupe brings to the world of diagnostics, and let’s build together a more sustainable diagnostic industry for the future!

Discover our solutions here!

Take contact for a question, a meeting, or a quote : info@cergroupe.be