New Single-use Technologies to Advance Flexible Manufacturing Introduced

Merck have introduced three new products to support flexible manufacturing of biologics. The innovations, all designed to make single-use bioprocessing easier, safer and more efficient, 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 the Process Solutions business unit, Life Science, at Merck. “Merck’s new bioprocessing innovations demonstrate our commitment to developing superior single-use technologies that will drive implementation of flexible manufacturing technologies around the world.”

The 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 Merck’s industry-leading Pellicon® ultrafiltration product family.

The Millipak® Final Fill 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 maximises product yield and the transparent housing clearly shows fluid flow during the critical final filtration step.

Merck’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 Merck’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.