Jonas Anders: Platform Technologies
The concept of platform technologies started in the industry with the belief that one could purify all monoclonal antibodies the same sequence of technologies: Protein A, cation exchange and then anion exchange. While this is true, what remains to be defined for each new molecule are the specific parameters for each unit, type of resin, pH, etc. For example, there is always more than one protein A resin that might deliver better results during purification. Same for cation and anion exchange and process parameters such as pH.
Most companies we work with have a defined toolbox of resins for the three step process and select from that predefined toolbox with each new molecule. This limits the parameter space to a certain extent. By defining a certain sequence of preset technologies, one can experience more rapid process development and ultimately increase speed to market.
The platform approach works well for monoclonal antibodies as they all have a common parameter – they all bind to protein A during the capture step. Use of templates outside the monoclonal antibody space still needs to be explored. With microbially-expressed proteins or biosimilars, each is different and this limits the ability to establish a set of platform technologies. Use of expression tags such as histidine can enable development of a platform as some type of common, generic feature is needed.
Even with a platform in place, it is important to evolve it as necessary to incorporate new technologies and add new parameters to the toolbox.