News | April 17, 2018

MilliporeSigma Introduces New Single-Use Technologies To Advance Flexible Manufacturing

Source: MilliporeSigma
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Burlington, MA - MilliporeSigma today introduced three new products to support flexible manufacturing of biologics. The innovations, all designed to make single-use bioprocessing easier, safer and more efficient, will be unveiled at the International Pharmaceutical Expo (INTERPHEX), held April 17-19 in New York City.

They are:

  • Pellicon® Capsule with Ultracel® Membrane, a first-of-its kind single-use tangential flow filtration device that advances flexible manufacturing
  • Millipak® Final Fill Filter, for high-value, small-volume processing
  • Mobius® Power MIX 2,500-Liter and 3,000-Liter large-scale single-use mixers.

“The biopharmaceutical industry needs flexible manufacturing solutions that reduce long drug development timelines and accommodate shifts in demand, while protecting employees and the environment,” said Andrew Bulpin, head of Process Solutions at MilliporeSigma. “MilliporeSigma’s new bioprocessing innovations demonstrate our commitment to developing superior single-use technologies that will drive implementation of flexible manufacturing technologies around the world.”

At INTERPHEX -- the premier pharmaceutical, biotechnology and medical device development and manufacturing event in the U.S. -- MilliporeSigma introduced its new Pellicon® Capsule with Ultracel® Membrane, the first-of-its-kind single-use tangential flow filtration capsule for bioprocessing of antibody-drug conjugates and monoclonal antibodies. The capsule combines fast, user-friendly and efficient processing of biologics with reliable performance and linear scalability. The capsule also reduces risk of product cross-contamination, as well as exposure to highly toxic compounds during processing and disassembly. It is the newest addition to MilliporeSigma’s industry-leading Pellicon® ultrafiltration product family.

Also introduced at INTERPHEX is MilliporeSigma’s Millipak® Final Fill Filter. This filter was designed with an angled, innovative Aseptic Multi-Purpose port for sampling, venting and integrity testing through the same port while protecting against microbial contamination and ensuring sterility of the drug product. The stacked disc design maximizes product yield, and the transparent housing clearly shows fluid flow during the critical final filtration step.

MilliporeSigma’s new Mobius® Power MIX 2,500-Liter and 3,000-Liter single-use mixers handle difficult-to-mix buffers, cell culture media powders and other pharmaceutical ingredients. Both large-scale systems incorporate NovAseptic® technology, traditionally used in stainless steel mixers, saving time and enabling more efficient single-use mixing. The new mixers extend MilliporeSigma’s product line, which now includes single-use mixing at scales ranging from 100 liters to 3,000 liters. All Mobius® Power MIX systems offer easy bag installation and product sampling to save customers’ time.

MilliporeSigma representatives will be available to discuss these innovative technologies at Booth 2841 at INTERPHEX, April 17–19, at the Javits Center in New York City.

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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 is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has five businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Life Science and Performance Materials – and generated sales of €15.3 billion in 2017. More than 52,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges.

Merck KGaA, Darmstadt, Germany is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. The company holds the global rights to the name and the trademark “Merck” internationally except for the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

SOURCE: MilliporeSigma