Optimal process mode selection for clone screening

A significant amount of data is generated during clone screening procedures because several cultivation systems are used such as well-plates, shake-flasks, laboratory-scale bioreactors among others. The amount of data can often be staggering and thus requires the use of statistical and data mining procedures in order to extract hidden information. In regard to a biosimilar monoclonal antibody project, data from the shake-flask scale was observed when comparing batch and fed-batch processes for several individual clones derived from two different cell lines. The aim of the research presented in this paper was to determine if clone selection based on batch data during the initial screening phase was equivalent to the results from fed-batch selection. It was determined that fed-batch processes should be implemented early during the screening procedure, if a choice is made that the final manufacturing process should also be operated in a fedbatch mode, as clone selection based on both batch and fed-batch analytical data was divergent.Pri izboru produkcijskega klona je potrebno zbrati in ovrednotiti veliko količino podatkov, saj pri izboru uporabljamo različne gojitvene sisteme, kot so na primer ploščice z gojitvenimi jamicami, erlenmajerice, bioreaktorji itd. Obdelava vseh podatkov je ponavadi zelo dolgotrajna in pogosto je potrebno uporabiti različne matematične in statistične metode za ovrednotenje skritih informacij. V pričujočem članku smo primerjali podatke pridobljene pri gojenju skupine klonov, ki proizvajajo monoklonsko protitelo, in sicer tako šaržne rezultate kot tudi analitske rezultate pridobljene pri semi-šaržnem gojenju kulture, torej z dohranjevanjem. Cilj raziskave je bil ugotoviti ali so šaržno pridobljeni podatki ekvivalenti podatkom pridobljenih s semi-šaržnim procesom in kako te vrednosti vplivajo na izbor produkcijskega klona. Ugotovili smo, da podatki, pridobljeni z različnimi procesnimi ustroji, niso primerljivi, kar kaže na potrebo, da se v izboru produkcijskega klona uporabi tisti procesni ustroj, ki je načrtovan za samo industrijsko produkcijo