Buffer Management Solutions for Large-Scale Biomanufacturing

GE Healthcare knows that rising titers upstream are a challenge downstream. That’s why the company is putting its more than 50 years’ downstream experience to work helping you to intensify your process and improve the economy, today and in the future.

The company’s featured products and services include MabSelect Protein A Resins, Capto high-productivity resins and Axichrom automated columns.

MabSelect Protein A Resins

GE Healthcare provides high-capacity reins for efficient processing of monoclonal antibodies (mAbs) and crystallizable fragment (Fc) fusion proteins. These offer key benefits such as:

  • A legacy of innovation in chromatography resin – For more than four decades, GE Healthcare has continuously enhanced the power of its protein A resins to increase productivity and efficiency of mAb purification processes. This leadership in innovation has resulted in faster process development and standardized manufacturing to shorten time-to-market.
  • Improved productivity and bioburden control – MabSelect PrismA is a next-generation protein A chromatography resin offering significantly enhanced alkaline stability and binding capacity for improved bioburden control and process economy in mAb processing.
  • A purification platform for mAbs – mAbs exhibit many shared properties. This makes a platform approach to purification of mAbs suitable. A plug-and-play platform allows high throughput of projects all the way from process development to manufacturing.
  • Ability to meet future demand in mAb processing – The rapidly growing demand for mAbs calls for elevated manufacturing capacity. Therefore, antibody titers in upstream processes have dramatically increased. Chromatography resins must match this change. Modern processes require resins with high capacity and chemical stability for high yields and long resin lifetime.
  • Optimized productivity through process design – Have you ever applied the concept of variable loading to gain productivity? Varying residence time (RT) over the loading phase can significantly improve productivity from a protein A chromatography step.

Capto high-productivity resins

GE Healthcare offers scalable resins for a wide range of chromatography techniques. Its benefits include:

  • Gaining 95% productivity in chromatography operations – Modern resins such as Capto contribute to increased productivity through high binding capacity and high flow rates. By using modern resins, you can increase facility throughput.
  • Confidence in bioprocessing – It is crucial to have a continuous supply of chromatography resins, even under unforeseen circumstances. To help you maintain manufacturing of vital biopharmaceuticals, Capto resins come with GE’s security of supply program and comprehensive regulatory and application support.
  • A diversified pipeline creates new needs – Diversity is increasing in today’s biopharmaceutical pipeline. With many different types of molecules, it is difficult to use a platform approach for purification. Instead, you need to use a broad range of techniques, including affinity, ion chromatography (IEX), hydrophilic interaction chromatography (HIC) and multimodal chromatography.
  • Separation of large molecules efficiently – Within therapeutic areas such as gene therapy and vaccines, the molecules purified adds new hurdles in the purification process. The large size and diversity of these molecules challenge the capacity and resolution of the resin.
  • Reaching efficient separation at large scales – Efficient separation requires an optimally packed bed. Special precautions and support are required for resins with high mechanical stability.

Axichrom automated columns

GE Healthcare intensifies downstream processing by:

  • Decreasing packing time up to 80% – Today, it is possible to get packing right at first try. Automated chromatography column packing can save you both time and labor costs, compared with pack-in-place columns. Verified and automated packing methods help you achieve packing success independent of previous experience.
  • Looking at the bigger picture – There is more to chromatography than the column. The ÄKTA systems support GE Healthcare’s columns throughout scales. Easy buffer management can also be integrated into the process. Different levels of automation are available through UNICORN software and DeltaV Distributed Control System.

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