Prof. Dr. Hartmut Schlüter Discusses: “Breaking the Bottleneck…”
For more efficient, effective chromatographic purification of proteins, chromatographic materials providing higher selectivities towards individual target proteins are needed. A lack of these materials results in the requirement for several chromatographic purification steps, increasing the costs associated with downstream processing. This problem is even worse if the purification of single protein species (protein isoforms) is necessary.
I expect that it will become increasingly necessary to purify biopharmaceuticals down to the protein isoform level as it is more and more obvious that within the total population of a recombinant protein, only certain subpopulations (defined protein species) show the desired action.
In order to meet this challenge, new processes must be developed which allow accelerated production of tailor-made chromatographic materials specific to defined target proteins. These include the chemical synthesis of materials that guarantee a high affinity towards the specific physicochemical properties of the defined protein species.
Since it may be some time until such customized chromatographic materials are available, solutions that leverage existing chromatographic materials must be applied. Rational screening of larger sets of parameters for identifying those that guarantee an optimal chromatographic purification should be applied. Typical parameters tested in screening experiments are chromatographic materials, pH, buffers, salt concentrations, solvents and additives. Furthermore, sample application conditions as well as washing steps and elution procedures can be screened
Consequent application of rational screening of a large set of parameters decreases the costs for purification of biologics.