BioSpectrum (India) - - WHO NEWS - Amit Khanna, Field Mar­ket­ing Man­ager- Filtration & Pu­rifi­ca­tion Tech­nolo­gies, Sar­to­rius Ste­dim In­dia

The bio­phar­ma­ceu­ti­cal in­dus­try is rapidly mov­ing to­wards sin­gle-use solutions for production. Ma­jor drive for sin­gle-use is multi prod­uct fa­cil­i­ties (esp. CMOs), time to mar­ket, quick clin­i­cal phase production, higher titers in up­stream which brings over­all scale of production down. An un­ex­pected bot­tle­neck in ex­ist­ing stain­less steel fa­cil­ity also ne­ces­si­tates sin­gle use im­ple­men­ta­tion for a quick res­o­lu­tion.

High vol­ume sin­gle-use biore­ac­tors, mix­ing sys­tems and stor­age solutions are al­ready es­tab­lished in the in­dus­try. High vol­umes are en­coun­tered dur­ing me­dia filtration, post clar­i­fi­ca­tion ster­ile filtration and viral vec­tor har­vest filtration. The cur­rent size of sin­gle use fil­ter cap­sule is a max­i­mum of 30 inch which may not be suf­fi­cient for large vol­ume pro­cess­ing. Tra­di­tional fa­cil­i­ties uti­lize multi-round hous­ings for this, a sin­gle-use ver­sion of such set-up was not avail­able un­til now. Mul­ti­ple cap­sules were con­nected in par­al­lel using Y con­nec­tion tub­ing to make a large sin­gle-use filtration unit. An 8 cap­sule ar­range­ment would re­quire mak­ing more than 10 man­ual con­nec­tions. Ster­il­iza­tion of such ar­range­ment or as­sem­bly un­der lam­i­nar flow area is an­other hur­dle.

Max­iCaps® MR from Sar­to­rius Ste­dim Biotech is a fully con­tained sin­gleuse as­sem­bly with up to 27 m² filtration area, de­signed for large scale filtration in bio­phar­ma­ceu­ti­cal ap­pli­ca­tions typ­i­cally more than 2000 L of pro­cess­ing vol­ume.

It is a ready to use pre-as­sem­bled, pre-ster­il­ized, dou­ble pack­aged sys­tem which has a small foot­print. It mit­i­gates the risk of in house as­sem­bly and ster­il­iza­tion of cap­sules. Hence, it helps a unit op­er­a­tion to save up to 4 hours. Ster­il­iza­tion is done using gamma ir­ra­di­a­tion method and all the com­po­nents used in the sys­tem are com­pat­i­ble with val­i­dated dose of ra­di­a­tion. The user is re­quired to make only the in­let and out­let con­nec­tion to in­te­grate Max­i­cap® MR in their process, mak­ing it a so­lu­tion that can be used ‘out of the box’. The con­nec­tion op­tions in­clude tri­clamp, ster­ile Opta® con­nec­tor or weld­able TPE tub­ing. Sin­gle-use pres­sure and flow-rate sen­sors can be con­nected eas­ily to the Max­iCaps® MR sys­tem for mea­sure­ment and con­trol of process op­er­at­ing pa­ram­e­ters.

The sys­tem has the op­tion of be­ing con­fig­ured to have 3, 6 or 9 fil­ter cap­sules of 30 inch each. It is pos­si­ble to fit ster­ile or biobur­den re­duc­tion fil­ters. In case of non­ir­ra­di­ated clar­i­fi­ca­tion fil­ters, the sys­tem can be sup­plied pre-as­sem­bled but non ster­ile. If an in­tegrity test­ing sys­tem is con­nected to the Max­i­cap® MR for in­tegrity test­ing of the fil­ters both pre and post use, the fil­ter cap­sules are not in­di­vid­u­ally tested but the to­tal sys­tem is tested for in­tegrity using meth­ods such as dif­fu­sion flow or for­ward flow. This fea­ture of in­tegrity test­ing of the com­plete sys­tem as a unit saves 90% time. The vent­ing of the sys­tem takes place through a spe­cially de­signed chan­nel with glass win­dow and gamma ra­di­a­tion com­pat­i­ble air fil­ter.

The sys­tem has un­der­gone com­pre­hen­sive val­i­da­tion test­ing, and its packaging for trans­porta­tion meets ASTM D4169-09 re­quire­ments.

Max­i­cap® MR is the an­swer to the long stand­ing prob­lem of multi-round sin­gle use filtration with added ben­e­fits of risk mit­i­ga­tion, time sav­ing, space sav­ing, less val­i­da­tion re­quire­ments and easy in­tegrity test­ing.

Amit han­dles the filtration & pu­rifi­ca­tion port­fo­lio of Sar­to­rius Ste­dim Biotech in In­dia & SAARC. An ex­pert in ar­eas like scaleup tri­als, in­tegrity test­ing for fil­ters & xflow cas­settes, process op­ti­miza­tion and trou­bleshoot­ing, Amit leads a team of ap­pli­ca­tion spe­cial­ists and reg­u­larly de­liv­ers talks and train­ings across the coun­try.


Con­ven­tionalMulti Round Hous­ing

Fil­ter Trol­ley

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