EMD Millipore Launches Eshmuno® A Chromatography Media and Chromabolt™ Prepacked Columns

16 Sept 2013

EMD Millipore, the Life Science division of Merck KGaA, Darmstadt, Germany, today introduced two additions to the Company’s comprehensive chromatography portfolio to further accelerate downstream purification and improve process efficiency.

Eshmuno® A is a rigid, high capacity, acid and alkaline resistant Protein A affinity chromatography media for the purification of monoclonal antibodies and other Fc-containing proteins. Higher binding capacities offered by Eshmuno® A media in comparison with other commercially available Protein A media delivers increased productivity and lower costs.

Eshmuno® A media can be cleaned and sanitized under acid and/or alkaline conditions while maintaining high dynamic binding capacity at high flow rates with no significant change in product purity. In addition, the media offers an orthogonal solution for aggregate removal at both the front and tail ends of the elution peak from the Protein A column. This property of the Eshmuno® A media is advantageous in reducing the burden of subsequent chromatography steps typically used in the purification of Fc–containing proteins.

“Optimizing the particle size and pore size of the Eshmuno® base matrix along with the immobilization of our proprietary ligand enables a significant increase in dynamic binding capacity,” states David Beattie, Ph.D., head Biopharm Process Solutions R&D, EMD Millipore. “This allows for higher loading of the Fc-containing protein being purified, maximizing column throughput and improving process economics. The ability to increase capacity and throughput with the Eshmuno® A media also allows our customers to more effectively process the high titers coming from upstream processing.”

Chromabolt™ prepacked, pre-validated chromatography columns, available with a range of EMD Millipore chromatography resins, are designed for early clinical stage manufacturing. Pre-validation indicates the columns meet bioburden, endotoxin, HETP and asymmetry pecification for the resin. Offered in 3 sizes – 10, 20 and 32 cm i.d. – Chromabolt™ prepacked columns eliminate laborious packing and equipment cleaning. The columns are currently available packed with Fractogel® SO3, Fractogel® TMAE HiCap, and Eshmuno® S resins. Going forward, additional resins will be made available in the Chromabolt™ format.

The prepacked columns are compatible with all currently available chromatography systems and connectors, have easily accessible inlets and outlets, and offer faster set-up times compared to traditional columns. Ergonomic and easily transportable by a single person, the 20 cm and 32 cm sizes are on wheels.

“Downstream processes must become faster, more lean, and cost-effective,” notes Vin Donovan, head of Biopharm Process Solutions business field, EMD Millipore. “With Chromabolt™ prepacked columns, we help customers accelerate pilot and early stage clinical scale manufacturing and lower their costs by eliminating manual packing and equipment cleaning.”

Chromabolt™ Prepacked Columns

Merck KGaA, Darmstadt, Germany

Chromabolt™ is a family of pre-validated columns prepacked with EMD Millipore chromatography resins, designed for early clinical stage manufacturing. Available in 3 sizes – 10, 20 and 32 cm inner diameter (i.d.), these prepacked columns free up end users valuable time and resources by eliminating manual packing and cleaning. With Chromabolt™ prepacked columns, you can spend your time on manufacturing your products and not on laboriously packing chromatography resins.Chromabolt™ Prepacked Columns Features: Column has been robustly designed to withstand damage in everyday use. Effortlessly transportable by a single person. Fully ergonomic and designed with EH&S considerations. Easily accessible inlets and outlets. Simple exterior cleaning and wiping. 20 cm and 32 cm i.d. columns on castors. Compatible with all currently available chromatography systems and connections.

(0)

Eshmuno® A Resin

Merck

Eshmuno® A is a rigid, high capacity Protein A affinity chromatography resin for the purification of Fc-containing proteins, including but not limited to monoclonal antibodies. Eshmuno® A resin can be cleaned and sanitized under acid and alkaline conditions while maintaining high dynamic binding capacity at high flow rates.The Eshmuno® A resin contains a EMD Millipore proprietary ligand. This ligand is recombinantely expressed in E. coli. No animal derived products are used during production. The Eshmuno® A resin is synthesized via immobilization of the ligand on to the Eshmuno® base matrix, which is a rigid and hydrophilic polymer based on polyvinylether.Eshmuno® A Resin Features: Productivity - high binding capacity, superior flow capability, reusability, and low cost of goods (COGS). Product purity - increased aggregate removal, excellent HCP reduction, low leached Protein A, consistent viral clearance, and reduced Fab binding. Scalability - linear scale-up. Reliability - batch-to-batch consistency, GMP manufacturing environment, and continuous regulatory support.

(0)

Links

Tags