MilliporeSigma Introduces New Single-use Technologies to Advance Flexible Manufacturing

• Innovations include first-of-its-kind single-use tangential flow filtration capsule for bioprocessing of antibody-drug conjugates and monoclonal antibodies
• Tangential flow filtration capsule, final fill capsule filter and large-scale mixers designed with operators in mind
• New products reduce risk, improve speed and ease of use

Burlington, Massachusetts, April 17, 2018 — MilliporeSigma, a leading science and technology company, 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), New York City, USA.

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-Litre and 3,000-Litre 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 Pellicon® Capsule with Ultracel® Membrane is 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-Litre and 3,000-Litre 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 litres to 3,000 litres. 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, USA.

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 some 22,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing, and testing services.

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science, and electronics. Around 58,000 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 2020, Merck KGaA, Darmstadt, Germany generated sales of € 17.5 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 Electronics. Since its founding in 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.