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Collaboration › Details

R-Biopharm–Candor Bioscience: immunoassays, 201311– strategic alliance in the area of companion diagnostics


Period Period 2013-11-13
Organisations Partner, 1st R-Biopharm AG
  Group R-Biopharm (Group)
  Partner, 2nd Candor Bioscience GmbH
Products Product ELISA assay (diagnostics) (enzyme linked immunosorbent assay)
  Product 2 companion diagnostic test

Candor Bioscience GmbH. (11/13/13). "Press Release: R-Biopharm AG Enters into a Strategic Alliance with Candor Bioscience GmbH". Wangen.

Seamless chain of competence from biomarkers to market-ready Companion Diagnostics for research-driven pharmaceutical and biotech companies

R-Biopharm, a global leader in providing innovative clinical diagnostics, enters into a strategic alliance with CANDOR Bioscience GmbH (Wangen, Allgäu, Germany), effective immediately.

R-Biopharm has its own corporate division for companion diagnostics (CDx), i.e. diagnostics concomitant to therapy, as well as for complementary diagnostics. There, R-Biopharm is at the spearhead of the current development of tests for new approaches in personalized medicine. R-Biopharm will further expand its position by means of an intensive co-operation with CANDOR: CANDOR has already carried out a large number of successful assay projects for university research clients, diagnostics manufacturers and leading pharmaceutical companies.

Thanks to their co-operation, R-Biopharm and CANDOR will be able to streamline the overall development process for immunological and phenotypical biomarkers while controlling the entire process chain - from the first research approach via pre-clinical and clinical phases all the way to the validated, approved and authorized diagnostic product.

Thus, important contributions to personalized medicine will be faster and more effective, and they will be more readily available for patients worldwide thanks to the R-Biopharm marketing competence.

Together, the two companies will cover the entire range of development. The experienced R-Biopharm CDx team will provide the project head for all biotech and pharmaceutical corporate co-operations. This ensures that only one single contact person will coordinate all project steps while still using the comprehensive competence of both CANDOR and R-Biopharm. Right from the start, CANDOR will assure compliance with the indispensable parameters accuracy, precision, LLOQ, ULOQ, as well as avoiding matrix and interference effects. If required, CANDOR will add proprietary technologies to achieve even better biomarker stability.

On this basis, regulatory checks, approvals and authorizations for test procedures can be handled more smoothly and faster so that R-Biopharm can then carry out the ensuing product development phases faster and more efficiently. Moreover, R-Biopharm can take on producing assays of any batch size - if required, even marketing the complementary diagnostics products. For production purposes, R-Biopharm can rely on their top modern production environment for immunodiagnostics, unique in Germany and Europe. Production can take place with a high degree of automation in clean rooms, and complying with all relevant guidelines, both for CE labeling and FDA approval, can be readily achieved thanks to the long-standing R-Biopharm expertise. New potential partners from biotech and pharmaceutical companies can inspect the on-going production quality anytime right on-site in Darmstadt.

Partners from the pharmaceutical and biotech industries will thus be able to focus on developing medication, knowing they have a partner at their side that provides twofold diagnostic strength, across the entire project duration - including development, validation, regulatory approval and authorization, production and marketing of companion diagnostics assays.

This new strategic partnership is a consistent next step undertaken by the two companies already connected by successful co-operation. In early July 2013, CANDOR won the R-Biopharm Supplier Awards 2013. On this occasion, R-Biopharm CEO Dr Ralf Dreher explained: "The long-standing co-operation with CANDOR is characterized by an extraordinary level of partnership, meeting deadlines and excellent processes throughout the supply chain. The innovative support CANDOR delivers for our R&D activities, for our ELISA RIDASCREEN test and towards process optimization, is truly tremendous."

Complementary Diagnostics

Complementary diagnostics represents an important move towards the convergence of in vitro diagnostics and therapeutics. Complementary diagnostics does not require a strict drug/diagnostic regulatory link at the time of development - thus opening up great new ways of research into in vitro diagnostics and its impact on therapeutics. The concept of complementary diagnostics also includes diagnostics concomitant to therapy (companion diagnostics), thus opening new opportunities, ensuring values and generating a competitive edge for pharmaceutical and biotech companies. The market share of already approved pharmaceuticals may sometimes be increased by complementary diagnostics. At the same time, the proportion of non-responders can be reduced in many cases. Side effects can sometimes be avoided altogether, so that the benefit and thus the value of pharmaceuticals can be increased also from a healthcare cost payer perspective.

R-Biopharm AG

R-Biopharm AG (Darmstadt, Germany) is a globally active life science company and a leading provider of reliable test systems for clinical diagnostics and for analyzing human food and animal feedstuffs. Since 1988, R-Biopharm has been developing innovative products characterized by top quality, reliability and efficiency. A strong sense of responsibility, long-standing experience and a network of 21 affiliated companies and subsidiaries in the US, Europe, South America, China and Australia, as well as more than 100 distribution partners, make R-Biopharm a prime address for clients from retail, industry and public institutions looking for answers and solutions for current analytical challenges.

CANDOR Bioscience GmbH

CANDOR Bioscience GmbH is an international company for the development, production and distribution of a comprehensive selection of premium solutions for immunoassays. CANDOR offers more than 50 different products including optimizers, blockers, stabilizers and buffers for immunoassays. By using these solutions the reliability of results can be improved, the assay can be simplified and process times can be reduced. Manufacturing is exclusively done by CANDOR itself, thus controlling all aspects of product quality.

Please contact:

R-Biopharm AG
Personalized Healthcare
Dr. Frank Apostel, Director of Business Development
An der neuen Bergstrasse 17
64297 Darmstadt, Germany

CANDOR Bioscience GmbH
Dr. Sabine Gloeggler
Simoniusstrasse 39
88239 Wangen, Germany

Record changed: 2017-04-02


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