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Information for commercial parties
Sanquin Research is actively involved in research with the aim of determining the immunogenicity of therapeutic antibodies. The formation of antibodies against various anti-TNFα-antibodies in patients and the clinical relevance thereof has been demonstrated and published by our research team (see Publications). Based on its proprietary technology Sanquin has developed a number of assays to monitor biopharmaceuticals and their immunogenicity in clinical practice.
With 30 years of experience in assay development, our longstanding expertise in the field of autoimmune diseases and close interaction with the clinic, Sanquin welcomes the opportunity to discuss with you how to best apply our knowledge & expertise for your company’s benefit.

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Immunogenicity of biologicals 2008.pdf

Sanquin Immunogenicity tests

Sanquin offers immunogenicity assaysAvailable tests
  1. of high sensitivity
  2. of high specificity
  3. of proven robustness and reliability
  4. using standard platforms
  • anti-infliximab
  • anti-adalimumab
  • anti-etanercept
  • anti-rituximab
  • anti-trastuzumab (for research purposes)
Tests in development:
  • anti-abatacept
  • anti-abciximab
  • anti-omalizumab

At the moment we are investigating a broader array of murine/chimeric/humanized and human biologicals for HAMA, HACA and HAHA responses.
Our assays are used for routine screening by Sanquin Diagnostic Services, providing immunogenicity testing for academic centres and hospitals in The Netherlands.



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Sanquin's team:
  1. acknowledged for its expertise in assay development
  2. strongly embedded in clinical surrounding
  3. knows what it takes to bring assays onto the market

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Academic collaboration
Sanquin is a member of ARTHRON a collaboration of academic and clinical centers in Amsterdam such as the Jan Van Breemen Institute - with in depth knowledge of the rheumatology field -, the Academic Medical Center AMC and Free University medical center VUmc, all involved in phase III trials for biologicals and all having a range of related biomaterials at their disposal.

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Sanquin offers licensing opportunities in the field of biologicals


Title
Patent application no.
Filing date

‘Methods and kits for detecting antibodies against therapeutic antibodies’
PCT/NL2008/050028
January 15th 2008

’Methods for increasing the therapeutic efficacy of IgG1 and IgG3 antibodies’
PCT/EP2008/000373
January 18th 2008

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Sanquin Reagents
The business unit Sanquin Reagents offers immuno-assays and assay components such as monoclonal antibodies, secondary labeled antibodies, buffers, and labeling compounds. Most of the hybdridoma clones were developed in-house and all monoclonal antibodies are produced in our facilities in Amsterdam. Examples are our anti-human IgG, -IgM, -IgA clones.
Sanquin Reagents offers bulk antibodies and other reagents to manufacturers of diagnostic kits all over the world. Sanquin Reagents is ISO9001 and ISO13485 certified, and all our reagents and kits for in vitro diagnostic use are CE-marked and comply with the 98/79/EC IVD Guideline.

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Sanquin Pharmaceutical Services
Sanquin Pharmaceutical Services (SPS) is an experienced and certified Contract Service Organisation, holding GMP (production) and GCLP (safety testing) licenses. SPS offers a broad array of services aimed at the development of biologicals for in vivo and ex vivo applications such as monoclonal antibodies and r-DNA proteins. Our multi-purpose production plant and supporting laboratories (including preclinical facilities) are designed to meet the current regulatory requirements for the production and safety testing of biopharmaceuticals. SPS is experienced in designing production strategies and scale up of biopharmaceutical production using state-of-the-art fermentation and purification techniques, including potent virus inactivation and removing steps. In addition, SPS can provide a broad expertise in the field of biosafety testing and other supportive services, such as the process validation for demonstrating reduction of viruses and/or DNA during purification.

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Sanquin is interested in partnering with:
    • Pharmaceutical companies
    • Biotech companies
    • Diagnostic companies
    • Service testing laboratories
    • CROs
    • Companies who offer personalized medicine approaches

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