For clinical development and manufacturing of biopharmaceuticals
January 7, 2013, Darmstadt, Germany — Merck Millipore, the Life Science division of Merck, today launched the Mobius® FlexReady Solution with Smart Flexware® Assemblies for tangential flow filtration (TFF). The fully-automated system is ready to implement and features scalable, industry-leading filtration technologies for unmatched performance and operational flexibility.
Unlike traditional single-use processing systems, this modular system is quick and easy to set up, providing the ability to switch from TFF to Chromatography with a minimum number of component changes, making it ideal for pilot plants and CMOs that have rapidly changing demands.
The system is suited for a wide range of concentration and diafiltration processes. In addition to the feed pump and retentate valve control loops, the system also includes an automated flow control valve on the filtrate line to enable open ultrafiltration and microfiltration operations, increasing the overall flexibility for clinical development and manufacturing facilities.
A variety of recycle vessel configurations are available with the Mobius® FlexReady Solution to provide maximum process capability. In addition to different vessel volumes, users can select a plastic carrier or a double-jacketed stainless steel carrier, depending on whether or not temperature control is required. All recycle vessels come with integrated load cells, mixer, and temperature sensor, and have been designed such that the containers can be easily and accurately installed by a single operator.
“With the introduction of this fully automated Mobius® single-use TFF system, we are able to provide our customers that require a high level of processing control a choice for performing their Ultrafiltration/diafiltration operations,” notes Vin Donovan, Vice President of Biopharm Process Solutions. “Users now have one platform for two process steps (TFF and Chromatography) with both systems sharing the same Smart Cart and software, thus streamlining the capital investment and learning curve while speeding their molecule to clinic.”
The Smart Flexware® single-use flow path delivers equivalent or better performance to that of traditional stainless steel systems while maximizing system flexibility. Smart Flexware® assemblies are easy to install, reducing the risk of operator error and challenges typically associated with installing single-use flow paths. Additionally, the flow path significantly reduces dead-legs and moving parts, decreasing the risk of contamination to virtually zero.
Merck Millipore’s Mobius® FlexReady Solutions provide the industry’s only complete single-use process train, offering both upstream and downstream solutions that reduce the time and resources required for commercial protein manufacturing. Comprehensive services, including IQ/OQ, process qualification consultancy and first run support, ensure rapid implementation and optimized performance.
For more information, please visit www.merckmillipore.com/mobius.
About Merck Millipore
Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers’ success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to customers and helps advance the promise of life science.
Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2011 revenues of EUR 2.4 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada.
Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany