Start­ing Strong with As­sured Sup­ply of Qual­i­ty Ma­te­ri­als for Im­mune Cell Ther­a­pies

This blog post is the sec­ond in a se­ries about ac­cel­er­at­ing the de­vel­op­ment and man­u­fac­tur­ing of cell-based can­cer ther­a­pies. In the last post, we out­lined the promise and po­ten­tial of im­mune cell ther­a­pies to treat can­cer along with an overview of the cen­tral chal­lenges that im­pede their broad ac­ces­si­bil­i­ty. In this ar­ti­cle, we take a clos­er look at key con­sid­er­a­tions for es­tab­lish­ing a re­li­able sup­ply chain of qual­i­ty ma­te­ri­als to en­sure a ro­bust and re­pro­ducible work­flow.

As im­mune cell ther­a­pies ad­vance through the de­vel­op­ment pipeline, the need for an op­ti­mal scal­ing strat­e­gy be­comes more ap­par­ent. Much of the de­lib­er­a­tion cen­ters around cell ex­pan­sion ap­proach­es to at­tain clin­i­cal­ly rel­e­vant cell num­bers and fea­tures such as au­toma­tion and process con­trol to en­sure high-qual­i­ty cell prod­ucts. Yet there are many more de­ci­sions to be made that can to a large de­gree de­ter­mine the ul­ti­mate suc­cess or fail­ure of a large-scale im­mune cell ther­a­py man­u­fac­tur­ing process, such as which start­ing ma­te­ri­als to use and which sup­pli­ers to part­ner with.

At clin­i­cal stages, cell ex­pan­sion, vi­a­bil­i­ty, and ef­fi­ca­cy de­pend on the time­ly ar­rival of high-qual­i­ty GMP raw ma­te­ri­als and reagents, and any dis­rup­tion in sup­ply can lead to vari­abil­i­ty or de­lays in the process and prod­uct. And while as­sured sup­ply of source ma­te­r­i­al has al­ways been ap­pre­ci­at­ed, dis­rup­tions due to COVID-19 high­light­ed how im­per­a­tive it is to es­tab­lish re­silient and flex­i­ble sup­ply chains from the start. Fail­ure to mit­i­gate dis­rup­tions can re­sult in cost­ly time de­lays and ul­ti­mate­ly grave con­se­quences for the pa­tient. There­fore, when choos­ing start­ing ma­te­ri­als, both qual­i­ty and as­sured sup­ply of re­sources must be eval­u­at­ed for suc­cess­ful scale-up.