Darmstadt, Germany, September 20, 2017 — Merck, a leading science and technology company, today launched Eshmuno® P anti-A and Eshmuno® P anti-B affinity chromatography resins specifically designed to remove anti-A and anti-B isoagglutinin antibodies during the manufacturing of plasma-derived immunoglobulin (Ig) therapies.
Trace amounts of anti-A and anti-B antibodies in plasma-derived Ig can lead to serious and sometimes fatal hemolytic events in patients undergoing plasma-based treatment. Introduction of chromatographic steps using Eshmuno® P resins to specifically deplete anti-A and anti-B antibodies is expected to reduce patient risk for adverse medical events associated with plasma-derived Ig therapies. This enhanced patient safety is achieved without negatively impacting process economics by reusing the resins for at least 200 cycles, with acid or alkaline cleaning, without loss of performance.
Eshmuno® P anti-A and Eshmuno® P anti-B resins are manufactured using a combination of Merck’s proprietary base matrix technology and a novel synthetic approach. The resins are released by an innovative test method to evaluate performance with significantly less variability compared with classical agglutination methods.
Merck has the right to grant non-exclusive sublicenses to certain patents and patent applications owned and controlled by LFB (Laboratoire français du Fractionnement et des Biotechnologies S.A.), strictly limited to the use of Eshmuno® P Anti-A and/or Eshmuno® P Anti-B resins for research, development and manufacture of plasma products (including toll and contract manufacturing for third parties). Customers who would like to purchase Eshmuno® P anti-A and/or Eshmuno® P anti-B resins from Merck will be provided further details regarding the availability of the foregoing sublicense.
Merck’s range of Eshmuno® and Fractogel® EMD chromatography resins are designed for efficient bioprocessing purification and are extensively used in commercial processes. These resins are well suited to support plasma purification processes, while minimizing operational costs and time to clinic.
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.