Buffer reuse for sustainable production of biologics and vaccines

Purpose and goal:

The idea of the project is to develop methodology to experimentally evaluate new strategies to reuse, recycle and minimize consumption of buffer. In order to enable reuse and recycle of buffer industrially, the technology needs to be experimentally validated and documented for evaluation with regard to regulatory eligibility requirements. In order to carry out these complex studies, a complete downstream process for the production of biological drugs is needed, where it is possible to recirculate buffer in different ways.

Expected results and effects:

Reducing water consumption in the production of biologics and vaccines is the single largest contribution that can be made to achieving significant reductions in the industry´s climate footprint. Realistic measures of reduced buffer consumption through direct recirculation are 20-40%. Developing an experimental methodology for how product and buffer quality is affected by buffer recirculation over a long period of time is the main result of the project.

Approach and implementation:

The work is divided into two work packages; i) recirculation within a separation step, which means local adaptation of the process step and its control system, ii) reuse between separation steps, which requires a process-wide buffer management system. To this are added studies of product and buffer quality in connection with buffer recirculation. The work is limited to studying buffer reuse in an integrated downstream process for purification of monoclonal antibody against breast cancer (Herceptin).