Achiev­ing Dig­i­tal Trans­for­ma­tion: Un­lock­ing Cost Re­duc­tion, Clin­i­cal Ex­cel­lence & Pre­ci­sion Ther­a­peu­tics Man­u­fac­tur­ing

In the dy­nam­ic land­scape of phar­ma­ceu­ti­cal and biotech in­dus­tries, L7 In­for­mat­ics is lead­ing the charge in trans­form­ing tra­di­tion­al op­er­a­tions through dig­i­tal in­no­va­tion. With a firm fo­cus on cost re­duc­tion, clin­i­cal im­prove­ments, re­duc­ing tech-trans­fer times, L7 In­for­mat­ics is rev­o­lu­tion­iz­ing the way com­pa­nies re­search, de­vel­op, and man­u­fac­ture while al­so pri­or­i­tiz­ing the well-be­ing of pa­tients and providers there­by paving the way for a fu­ture where pa­tients re­ceive bet­ter treat­ments at low­er costs.

The ma­jor pain points af­fect­ing pre­ci­sion ther­a­peu­tics man­u­fac­tur­ing ca­pa­bil­i­ties are well-known with­in the in­dus­try. The re­liance on pa­per-based process­es and spread­sheets for op­er­a­tions can cause sig­nif­i­cant bot­tle­necks in pro­duc­ing and re­leas­ing cell and gene ther­a­py (C&GT) prod­ucts to pa­tients. Cur­rent so­lu­tions lack the flex­i­bil­i­ty or com­pos­abil­i­ty need­ed in this in­dus­try, im­ped­ing speed, ef­fi­cien­cy and qual­i­ty. L7 In­for­mat­ics rec­og­nized these chal­lenges and set out to build a holis­tic dig­i­tal so­lu­tion that al­le­vi­ates the lim­i­ta­tions of pa­per or siloed dig­i­tal ap­proach­es and is based on the prin­ci­ples of In­dus­try 4.0.

To achieve this, we lever­aged our flag­ship plat­form, L7|ESP™, and em­barked on a mis­sion to stream­line pre­ci­sion ther­a­peu­tics man­u­fac­tur­ing. By au­tomat­ing gov­er­nance and pro­ce­dures, L7 In­for­mat­ics sought to elim­i­nate the re­liance on pa­per and spread­sheets, en­sur­ing process con­trol and pa­tient safe­ty. We fo­cused on dig­i­tal­iz­ing the points where “peo­ple meet process,” re­plac­ing pa­per and spread­sheet trans­ac­tions with a dig­i­tal so­lu­tion in­cor­po­rat­ing qual­i­ty by de­sign (QbD) prin­ci­ples and re­al-time feed­back.

A typ­i­cal clean­room man­u­fac­tur­ing sys­tem in­volves mul­ti­ple de­part­ments in­ter­act­ing and ex­chang­ing in­for­ma­tion, doc­u­ments, ma­te­ri­als, equip­ment, sam­ples, and prod­ucts through­out var­i­ous stages. How­ev­er, tra­di­tion­al MES so­lu­tions fail to ad­dress the func­tion­al gaps in man­u­fac­tur­ing op­er­a­tions, leav­ing or­ga­ni­za­tions heav­i­ly re­liant on pa­per batch records, forms, and spread­sheets. L7 In­for­mat­ics’ MES so­lu­tion pro­vides val­ue-added func­tion­al­i­ty for CMC to CGMP man­u­fac­tur­ing process­es, of­fer­ing easy nav­i­ga­tion, fa­mil­iar lay­outs, qual­i­ty by de­sign fea­tures, in­ter­op­er­abil­i­ty with equip­ment and sys­tems, se­quen­tial ex­e­cu­tion con­trol, re­al-time da­ta tabs, com­pli­ance with reg­u­la­tions, ef­fec­tive com­mu­ni­ca­tion, file at­tach­ments, and re­al-time trend gen­er­a­tion.

L7 In­for­mat­ics’ dig­i­tal trans­for­ma­tion ap­proach ex­tends be­yond in­di­vid­ual de­part­ments. The com­pa­ny em­pha­sizes the need for uni­fied plat­forms that con­nect da­ta seam­less­ly across de­part­ments, break­ing down op­er­a­tional and in­for­ma­tion­al si­los. L7 In­for­mat­ics en­ables or­ga­ni­za­tions to un­lock their full po­ten­tial and max­i­mize ef­fi­cien­cy by elim­i­nat­ing frag­ment­ed sys­tems and fos­ter­ing in­ter-de­part­men­tal col­lab­o­ra­tion. This “dig­i­tal col­lab­o­ra­tion” can then be ex­tend­ed across com­pa­nies.

By dri­ving dig­i­tal trans­for­ma­tion and op­ti­miz­ing work­flows, L7 In­for­mat­ics al­so ad­dress­es the press­ing goals of cost re­duc­tion and clin­i­cal im­prove­ments. The com­pa­ny un­der­stands that a com­pre­hen­sive and sys­tem­at­ic ap­proach is es­sen­tial for long-term suc­cess. By lever­ag­ing our da­ta me­chan­ics, AI, ma­chine learn­ing, and sup­ply chain man­age­ment ex­per­tise, L7 In­for­mat­ics pro­vides in­no­v­a­tive so­lu­tions that yield mea­sur­able re­sults and dri­ve con­tin­u­ous im­prove­ment.

L7 In­for­mat­ics is com­mit­ted to dri­ving dig­i­tal trans­for­ma­tion and fos­ter­ing a col­lab­o­ra­tive com­mu­ni­ty that em­braces a sys­tems-based ap­proach to tack­le the press­ing needs of to­day. The com­pa­ny or­ga­nizes three im­pact­ful events to ed­u­cate fur­ther and ex­plore joint ini­tia­tives. These events boast an im­pres­sive line­up of thought lead­ers and ex­perts in the field.

Among these events are L7|LIVE, day-long sem­i­nars held in Boston (3/23/23) and San Fran­cis­co (6/13/23), which pro­vide an im­mer­sive plat­form for in­dus­try pro­fes­sion­als to en­gage in dis­cus­sions, share knowl­edge, and ex­change ideas. These sem­i­nars bring to­geth­er ex­ec­u­tives ded­i­cat­ed to re­al­iz­ing dig­i­tal trans­for­ma­tion and serve as a cat­a­lyst for in­no­va­tion and col­lab­o­ra­tion.

Ad­di­tion­al­ly, L7 In­for­mat­ics hosts a three-day event, L7|UNI­VERSE, in Austin. This gath­er­ing is a con­ver­gence point for in­dus­try lead­ers pas­sion­ate about dri­ving dig­i­tal trans­for­ma­tion in life sci­ences. At L7|UNI­VERSE, par­tic­i­pants can ex­plore the lat­est trends, share ex­pe­ri­ences, and learn from com­pelling case stud­ies that ad­dress cur­rent chal­lenges, of­fer­ing ac­tion­able in­sights to dri­ve mean­ing­ful change.

Please click here to learn more about L7 In­for­mat­ics or join us at an up­com­ing event.


Vasu Rangadass, Ph.D.

President & CEO of L7 Informatics, Inc.