Merck Millipore has launched its PDReady™ for Monoclonal Antibodies (MAbs) Kit for accelerating process development timelines.
The kit is based on a robust process development template using 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 Merck Millipore technical experts, and equipment such as the Cogent® µScale 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 Merck Millipore's proven technologies to deliver a template for rapid and efficient downstream process development," said Vin Donovan, Vice President of Biopharm Process Solutions.
Donovan continued, "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
- Robust clarification in an easy-to-use format
• Affinity Chromatography - ProSep® Media
- Designed for cost-effective purification of high titer therapeutic antibodies
• Cation Exchange Chromatography - Fractogel® Media
- Provides reliability with optimal yields and efficient purification
• Anion Exchange Chromatography - ChromaSorb™ Membrane Absorber
- Provides the greatest levels of impurity binding at the highest salt concentrations for monoclonal antibodies
• Virus Filtration - Viresolve® Filters
- Robustly retains viruses while ensuring maximum product recovery
• Ultrafiltration - Pellicon® 3 Cassettes
- 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
- Provides sterility assurance, broad chemical compatibility, high flow rates and exceptionally high capacity
• Cogent® µScale TFF System
- Easy-to-use, semi-automated bench top TFF system for micro-scale process development and everyday low-volume ultrafiltration/diafilitration