Presented by Mikkel Nissum, Vaccine R&D Quality Site Lead at GSK Vaccines
Only clean drinking water rivals vaccination in its ability to save lives. Yet, development and manufacturing of vaccines remain challenging. Vaccines comprise a heterogeneous variety of targets. Each target requires a dedicated development and manufacturing process adding to the timelines for getting new vaccines to the patient and to ensure a reliable supply. For the downstream processing part, often the process is composed of an optimized set of up to three chromatographic steps to provide the final desired quality of the target. On top of the long development time required to develop such a multi-step process, at times, the end result may not be satisfactory, in particular regarding purity of the target.
In order to overcome this downstream processing challenge, we embarked on establishing a purification platform based on affinity purification. The main advantages of such a platform for vaccine manufacturing would be:
1)By applying a positive selection principle for chromatography, the number of chromatographic steps may be reduced to just one step
2)Establishing a platform would require minimal process changes from one target to another
3)Downstream processing would become predicable in terms of development time and costs
The journey of establishing the affinity purification platform focusing on main challenges and key results will be presented in the Webinar.