Billerica, MA — EMD Millipore, the Life Science division of Merck KGaA, Darmstadt, Germany, today launched its PDReady™ for Monoclonal Antibodies (MAbs) Kit for accelerating process development timelines. The kit is based on a robust process development template using state-of-the-art technologies for each purification operation. Every step within the template uses a technology already proven to successfully purify MAbs, allowing biopharmaceutical manufacturers to rapidly develop a reliable purification process that delivers high purity and yield.

The PDReady™ for MAbs Kit reduces the complexity of process development by providing a single integrated package including purification devices, precise protocols to guide process development, specific recommendations for required laboratory tools, support from EMD Millipore technical experts, and equipment such as the Cogent® mScale that is loaned to the customer. Each unit operation within the template is designed for convenient scaling from bench to clinic. By employing a proven template for MAb purification, the necessary experimentation for process development is drastically reduced, saving time, money and effort, while still developing a robust process.

“The PDReady™ for MAbs Kit leverages EMD Millipore’s proven technologies to deliver a template for rapid and efficient downstream process development,” said Vin Donovan, Vice President of Biopharm Process Solutions. “Our experience with these technologies in monoclonal antibody processes allows us to establish known process parameters, drastically reducing the experimentation required to achieve drug purity and yield targets. This speeds the time to clinic and ultimately commercial-scale production.”

Purification unit operations within the PDReady™ for MAbs Kit include:

• Clarification – Millistak+® Pod Filter System

o Robust clarification in an easy-to-use format

• Affinity Chromatography – ProSep® Media

o Designed for cost-effective purification of high titer therapeutic antibodies

• Cation Exchange Chromatography – Fractogel® Media

o Provides reliability with optimal yields and efficient purification

• Anion Exchange Chromatography – ChromaSorb™ Membrane Absorber

o Provides the greatest levels of impurity binding at the highest salt concentrations for monoclonal antibodies

• Virus Filtration – Viresolve® Filters

o Robustly retains viruses while ensuring maximum product recovery

• Ultrafiltration – Pellicon® 3 Cassettes

o Tangential flow filtration device of choice for demanding filtration processes, including higher operating pressures, temperatures and caustic cleaning regimes

• Sterile Filtration (including buffers) – Millipore Express® Filters

o Provides sterility assurance, broad chemical compatibility, high flow rates and exceptionally high capacity

• Cogent® µScale TFF System

o Easy-to-use, semi-automated bench top TFF system for micro-scale process development and everyday low-volume ultrafiltration/diafilitration

For more information on the PDReady™ for MAbs Kit, please visit www.emdmillipore.com/pdready.

About EMD Millipore

EMD 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, EMD 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. EMD Millipore is known as Merck Millipore outside of the U.S. and Canada.