Billerica, Massachusetts, September 20, 2017 — MilliporeSigma 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 MilliporeSigma’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.
MilliporeSigma 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 MilliporeSigma will be provided further details regarding the availability of the foregoing sublicense.
MilliporeSigma’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.
About the Life Science Business of Merck KGaA, Darmstadt, Germany
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 20,000 employees and 60 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery. Udit Batra is the global chief executive officer of MilliporeSigma.
Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry.
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 51,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2017, Merck KGaA, Darmstadt, Germany generated sales of €15.3 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck, KGaA, Darmstadt, Germany, visit www.emdgroup.com.