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Perspective

Outsourcing bioanalytical services at Janssen Research and Development: the sequel anno 2017

    Lieve Dillen

    *Author for correspondence:

    E-mail Address: ldillen@its.jnj.com

    Development Bioanalysis, Janssen R&D, Turnhoutseweg 30, 2340 Beerse, Belgium

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    &
    Tom Verhaeghe

    Development Bioanalysis, Janssen R&D, Turnhoutseweg 30, 2340 Beerse, Belgium

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    Published Online:1 Aug 2017https://doi.org/10.4155/bio-2017-0082

    Abstract

    The strategy of outsourcing bioanalytical services at Janssen has been evolving over the last years and an update will be given on the recent changes in our processes. In 2016, all internal GLP-related activities were phased out and this decision lead to the re-orientation of the in-house bioanalytical activities. As a consequence, in-depth experience with the validated bioanalytical assays for new drug candidates is currently gained together with the external partner, since development and validation of the assay and execution of GLP preclinical studies are now transferred to the CRO. The evolution to externalize more bioanalytical support has created opportunities to build even stronger partnerships with the CROs and to refocus internal resources. Case studies are presented illustrating challenges encountered during method development and validation at preferred partners when limited internal experience is obtained or with introduction of new technology.

    References

    • 1 Spooner N, Cape S, Hayes R et al. Issues facing the bioanalytical community: summary of round table discussions. Bioanalysis 8(21), 2189–2193 (2016).
      CASGoogle Scholar
    • 2 Benett P, Beyerlein D, Hucker R et al. Outsourcing in a bioanalytical laboratory. Ask the experts. Bioanalysis 5(20), 2456–2462 (2013).
      Google Scholar
    • 3 Zimmer D. Bioanalytical outsourcing: the two sides of the medal. Bioanalysis 5(17), 2095–2099 (2013).
      CASGoogle Scholar
    • 4 Zimmer D. Outsourcing strategy: local versus international contract research organizations. Bioanalysis 6(10), 1279–1281 (2014).
      CASGoogle Scholar
    • 5 Bennett P. Meeting the challenges of bioanalytical outsourcing: understanding the hidden cost of price pressure. Bioanalysis 3(22), 2491–2493 (2011).
      CASGoogle Scholar
    • 6 Summerfield SG, Evans C, Spooner N, Dunn JA, Szapacs ME, Yang E. Integrating internal and external bioanalytical support to deliver a diversified pharmaceutical portfolio. Bioanalysis 6(10), 1311–1319 (2014).
      CASGoogle Scholar
    • 7 Verhaeghe T. Bioanalytical outsourcing at Janssen Research and Development. Bioanalysis 6(10), 1321–1327 (2014).
      CASGoogle Scholar
    • 8 EMA reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/05/WC500127124.pdf.
      Google Scholar
    • 9 Dillen L, Loomans T, Van de Perre G, Versweyveld D, Wuyts K, de Zwart L. Blood microsampling using capillaries for drug-exposure determination in early preclinical studies: a beneficial strategy to reduce blood sample volumes. Bioanalysis 6(3), 293–306 (2014).
      CASGoogle Scholar
    • 10 Verhaeghe T, Dillen L, Stieltjes H et al. The application of capillary microsampling in GLP toxicology studies. Bioanalysis 9(7), 531–540 (2017).
      CASGoogle Scholar
    • 11 White S, Hawthorne G, Dillen L et al. European Bioanalysis Forum – reflection on bioanalytical assay requirements used to support liquid microsampling. Bioanalysis 6(19), 2581–2586 (2014).
      CASGoogle Scholar