MAb Development and Production
The development of genetically engineered monoclonal antibodies (MAbs) has transformed healthcare and our ability to produce new biomedicines. The high specificity of MAbs is beneficial in a wide range of therapeutic areas such as cancer and autoimmune conditions.
MAbs have become the dominant category of biotherapeutics, but because therapeutic antibodies are among the world’s most expensive categories of drugs, there are strong pressures to decrease manufacturing costs.
Tools for Cost-effective MAb Manufacturing
The relative homogeneity of MAbs makes them good candidates for a platform purification approach. Platform technologies are not just purification steps, but are sets of unit operations, conditions, and methods applied to a given class of molecules.
GE Healthcare’s platform technologies can help you achieve cost-efficient MAb process development and manufacturing. We offer high-flow separation media, high-throughput process development (HTPD) tools, disposable technologies, and breakthroughs in large-scale processing equipment.
Benefits of a Platform Approach
- Operational Efficiency and Reduced Time-To-Market: Applying a platform approach mean key aspects of development and processing are re-used. This saves time and money when developing a new MAb, and allows generic and predictable timelines.
- Cost Efficiency and Predictable Scale-Up: Using platforms means your process is a series of predictable activities that can efficiently be scaled up. This could potentially allow a larger number of candidates to be evaluated, and even reduce the effort and cost of validation.
- Quick Product Change-Over: Typical change-over can be performed in one week, or even less, when there are no unusual unit operations that require new equipment.