Process cost-mod­el­ing tools for process de­sign and tech­nol­ogy se­lec­tion

BioSpectrum (India) - - BIO CONTENT -

The abil­ity of bio­phar­ma­ceu­ti­cal com­pa­nies to de­velop man­u­fac­tur­ing pro­cesses that de­liver low costs of goods (CoGs) is be­com­ing more im­por­tant as the market be­comes in­creas­ingly com­pet­i­tive. Process cost-mod­el­ing tools can be used to un­der­stand bet­ter the im­pact of process de­sign and tech­nol­ogy choices on over­all process through­put and cost of goods. Bio­phar­ma­ceu­ti­cal com­pa­nies can use these tools to de­ter­mine whether they have a com­mer­cially vi­able process that will achieve the tar­get cost of goods by pre­dict­ing the im­pact of switch­ing to al­ter­na­tive process con­fig­u­ra­tions and scal­ing-up.

Our process-mod­el­ing ex­perts typ­i­cally use the BioSolve Process soft­ware from Bio­pharm Ser­vices. They have re­ceived the high­est lev­els of train­ing and have gained sig­nif­i­cant ex­pe­ri­ence through suc­cess­fully de­liv­er­ing many di­verse cost-mod­el­ing projects all over the world.

Process mod­el­ing can sup­port bio­phar­ma­ceu­ti­cal com­pa­nies dur­ing their early stage process de­vel­op­ment ac­tiv­i­ties. Process de­vel­op­ment sci­en­tists use these tools to iden­tify the most op­ti­mized process flows de­liv­er­ing the low­est costs. For anal­y­sis the soft­ware pro­vides helps to iden­tify spe­cific process steps with the po­ten­tial to have the great­est im­pact on over­all process economics. With this in­for­ma­tion, man­agers can di­rect sci­en­tists to in­vest their time and ef­fort into op­ti­miz­ing these unit op­er­a­tions and de­liver the best over­all out­come. For ex­am­ple, by us­ing this tool we were able to iden­tify that the steps in a MAb process with the high­est costs were the pro­duc­tion biore­ac­tor in up­stream pro­cess­ing and Pro­tein A and cation-ex­change chro­matog­ra­phy step in down­stream pro­cess­ing (Fig­ure 1). We can also as­cer­tain how the cost dy­nam­ics change with in­creas­ing titer. As the titer in­creases from 5 g/L to 10 g/L the im­por­tance of down­stream pro­cess­ing costs in­crease sig­nif­i­cantly.

Com­pa­nies can gain valu­able in­sights from process and cost mod­el­ing soft­ware when con­sid­er­ing the de­sign of new bioman­u­fac­tur­ing fa­cil­i­ties. In­creas­ingly firms have to de­cide whether to im­ple­ment stain­less steel equip­ment, sin­gle-use tech­nolo­gies or a com­bi­na­tion of the two us­ing a hy­brid ap­proach. Process mod­el­ing with BioSolve Process al­lows the Sar­to­rius In­te­grated So­lu­tions team in part­ner­ship with clients, to as­sess dif­fer­ent pro­duc­tion par­a­digms dur­ing the con­cep­tual phase of fa­cil­ity de­sign. Fig­ure 1 shows a comparison of the costs as­so­ciated with a stain­less steel fa­cil­ity, hy­brid fa­cil­ity and a sin­gle-use fa­cil­ity.

Equip­ment siz­ing and op­er­at­ing ap­proaches can be op­ti­mized by mak­ing de­sign as­sump­tions based on prior ex­pe­ri­ence and our knowl­edge of process plat­forms. These as­sump­tions may in­clude up­stream titer, biore­ac­tor vol­umes, num­bers, and the down­stream process se­quence. Once mod­el­ing ex­perts have per­formed a ba­sic anal­y­sis it is pos­si­ble to com­pare the cost per batch/year/dose or cost per gram of var­i­ous dif­fer­ent sce­nar­ios and for com­pa­nies to start ask­ing them­selves “what if?” ques­tions. Com­pa­nies are us­ing our ex­per­tise in cost mod­el­ing, for ex­am­ple, to as­sess the im­pact on mak­ing ma­jor process changes such as mov­ing from batch to con­tin­u­ous pro­cess­ing.

Priyanka Gupta

Global Se­nior, Bio­pro­cess Mod­el­ling Con­sul­tant,

Sar­to­rius Ste­dim Biotech

« Priyanka Gupta Global Se­nior Bio­pro­cess Mod­el­ling Con­sul­tant, Sar­to­rius Ste­dim Biotech

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