Berke­ley Lights’ unique func­tion-first ap­proach pro­vides ad­vance­ments in time­line, qual­i­ty, and rev­enues

In re­cent years, an­ti­body ther­a­peu­tics have be­come high-val­ue tar­gets ac­count­ing for 9 of 20 top-sell­ing ther­a­peu­tics and near­ly 20% of all FDA ap­provals. De­vel­op­ment of this class of drugs, how­ev­er, is plagued by par­tic­u­lar­ly low suc­cess rates due to lim­i­ta­tions in ef­fec­tive screen­ing ear­ly in the dis­cov­ery and de­vel­op­ment process. The re­sult­ing late-stage fail­ures not on­ly waste pre­cious time, but al­so dri­ve up costs while lim­it­ing the num­ber of an­ti­body ther­a­peu­tics that make it to mar­ket.

Berke­ley Lights is unique­ly po­si­tioned to ad­dress these chal­lenges with a plat­form that ac­cel­er­ates de­liv­ery of in­ves­ti­ga­tion­al prod­uct to clin­i­cal tri­als by as­sess­ing qual­i­ty of both an­ti­bod­ies and man­u­fac­tur­ing cell lines at the ear­li­est avail­able phase of dis­cov­ery and de­vel­op­ment. Al­ready adopt­ed by many top 25 phar­ma­ceu­ti­cal com­pa­nies, as well as lead­ing CROs and CD­MOs, the Berke­ley Lights Plat­form is ac­tive­ly be­ing used to de­liv­er high-qual­i­ty ther­a­peu­tics to clin­i­cal tri­als in record time.

John Proc­tor, Se­nior Vice Pres­i­dent of An­ti­body Ther­a­peu­tics at Berke­ley Lights, shares in­sights in­to how the Berke­ley Lights Plat­form is trans­form­ing an­ti­body ther­a­peu­tics and how a nov­el, sub­scrip­tion-based mod­el now broad­ens ac­cess.

How does the Berke­ley Lights Plat­form change the eco­nom­ics of an­ti­body ther­a­peu­tic de­vel­op­ment?

John Proc­tor: Berke­ley Lights has cre­at­ed a plat­form that not on­ly short­ens time­lines for an­ti­body dis­cov­ery and cell line de­vel­op­ment but al­so brings func­tion­al and qual­i­ty as­sess­ment ear­li­er in­to dis­cov­ery and de­vel­op­ment.

Our nov­el ap­proach ad­dress­es two preva­lent chal­lenges in to­day’s work­flows: lengthy time­lines to bring an an­ti­body to clin­i­cal tri­als and a high fail­ure rate. This adds up to price tags well above 1 bil­lion USD to com­mer­cial­ize a sin­gle mol­e­cule and 10+ years spent to get from tar­get to ap­proval. And COVID aside, these num­bers are not im­prov­ing. Bring­ing a mol­e­cule to mar­ket to­day is more dif­fi­cult be­cause of the fo­cus on GPCRs and oth­er dif­fi­cult tar­gets and more com­plex mol­e­c­u­lar for­mats, such as bis­pecifics and an­ti­body frag­ments.

Us­ing the Berke­ley Lights Plat­form, our cus­tomers can bring more and bet­ter mol­e­cules to clin­i­cal tri­als faster, ex­pand­ing pipelines and en­abling mil­lions in rev­enue.

Our cus­tomers can bring more and bet­ter mol­e­cules to clin­i­cal tri­als faster, ex­pand­ing pipelines and en­abling mil­lions in rev­enue.

Tell us about how your plat­form has al­ready changed your cus­tomers’ dis­cov­ery and de­vel­op­ment process­es.

John Proc­tor: Across the board, our cus­tomers are re­port­ing re­duced time­lines and greater suc­cess against dif­fi­cult tar­gets. GSK has shaved three months off their CLD crit­i­cal path time­lines. The Crowe lab at Van­der­bilt Uni­ver­si­ty was able to go from hu­man donor to man­u­fac­tur­ing-ready SARS-CoV-2 neu­tral­iz­ing an­ti­bod­ies in 18 days. Cus­tomers are find­ing an­ti­bod­ies against GPCRs and oth­er chal­leng­ing mol­e­cules where their hy­brido­ma-based work­flows failed. They are find­ing clones with 3-fold high­er titer. And they are do­ing this in record time.

This year, with the re­lease of our fourth-gen­er­a­tion an­ti­body dis­cov­ery work­flow and the ad­di­tion of Op­to™ As­sure qual­i­ty as­says to our CLD work­flow, cus­tomers will un­doubt­ed­ly re­al­ize ad­di­tion­al im­prove­ments be­cause we en­able them to as­sess func­tion and qual­i­ty much ear­li­er in dis­cov­ery and de­vel­op­ment. This func­tion-first ap­proach promis­es to stream­line de­vel­op­ment and con­tin­ue to dri­ve down time­lines.

We en­able [our cus­tomers] to as­sess func­tion and qual­i­ty much ear­li­er in dis­cov­ery and de­vel­op­ment.

Why is this func­tion-first ap­proach so crit­i­cal to in­creas­ing suc­cess rates and build­ing more sus­tain­able an­ti­body ther­a­peu­tic pro­grams?

John Proc­tor: For both dis­cov­ery and de­vel­op­ment of an­ti­body ther­a­peu­tics, as­sess­ing func­tion and qual­i­ty as ear­ly as pos­si­ble trans­lates in­to not on­ly speed and ef­fi­cien­cy but al­so high­er qual­i­ty prod­uct, more ro­bust pipelines, and max­i­mized eco­nom­ics.

A key chal­lenge of cur­rent work­flows is that they are un­able to elim­i­nate non-func­tion­al an­ti­bod­ies and cell lines that se­crete poor qual­i­ty prod­uct dur­ing pri­ma­ry screen­ing. Sig­nif­i­cant re­sources are spent on con­tin­ued de­vel­op­ment of mol­e­cules and cell lines that are des­tined for cost­ly late-stage fail­ure.

In an­ti­body dis­cov­ery, pri­ma­ry screens mere­ly iden­ti­fy hits. These then must be ad­vanced to la­bo­ri­ous down-se­lec­tion in sec­ondary screens. This is a very in­ef­fi­cient and al­so dis­ap­point­ing step – you are ad­vanc­ing 10, 100, or 1,000 hits and of­ten these screens yield just a hand­ful or even no func­tion­al lead mol­e­cules. By fold­ing func­tion­al char­ac­ter­i­za­tion in­to the pri­ma­ry screen, our newest an­ti­body dis­cov­ery work­flow lets our cus­tomers go di­rect­ly from tar­get to 1000s of func­tion­al­ly char­ac­ter­ized lead mol­e­cules in less than 1 week. Cus­tomers can now link func­tion­al pro­files to an­ti­body se­quences and re-ex­press lead mol­e­cules with our rapid re-ex­pres­sion kit in just 2 days with­out gene syn­the­sis and cloning. In just a lit­tle over 1 week, they can com­plete the dis­cov­ery process through func­tion­al con­fir­ma­tion and se­lec­tion of the best lead can­di­dates.

Our cell line de­vel­op­ment cus­tomers are faced with sim­i­lar­ly cost­ly late-stage qual­i­ty as­sess­ment. The more com­plex an­ti­body ther­a­peu­tic for­mats we see to­day are prone to qual­i­ty is­sues in­clud­ing ag­gre­ga­tion, which im­pact man­u­fac­tura­bil­i­ty, shelf life, and safe­ty. Clone se­lec­tion to­day, how­ev­er, is gen­er­al­ly made sole­ly on titer and it is not un­til scale-up that prod­uct qual­i­ty is­sues come to light. This means de­vel­op­ment teams spend sig­nif­i­cant re­sources car­ry­ing mul­ti­ple cell lines through to the cost­ly scale-up process in or­der to en­sure suc­cess. Our Op­to As­sure as­says change this by bring­ing prod­uct qual­i­ty as­sess­ment in­to ear­ly clone se­lec­tion to help min­i­mize risk dur­ing scale-up and to en­able se­lec­tion of clon­al cell lines with fa­vor­able man­u­fac­tura­bil­i­ty pro­files. This leads to de­creased scale-up costs and ul­ti­mate­ly bet­ter down­stream prod­ucts.

In both an­ti­body dis­cov­ery and cell line de­vel­op­ment this func­tion-first ap­proach trans­lates to ac­cel­er­at­ed time­lines and mil­lions in en­abled rev­enue.

How does your new sub­scrip­tion mod­el ex­pand ac­cess to the Berke­ley Lights Plat­form?

John Proc­tor: Our cus­tomers have been re­quest­ing tai­lored ac­cess to our tech­nol­o­gy that bet­ter match­es their ca­pac­i­ty needs. The all-in­clu­sive TechAc­cess* sub­scrip­tion pro­gram now pro­vides ac­cess to our an­ti­body dis­cov­ery and cell line de­vel­op­ment work­flows with no up-front cap­i­tal ex­pense or long-term com­mit­ment and pro­vides the de­sired ca­pac­i­ty flex­i­bil­i­ty. Those with low­er ca­pac­i­ty re­quire­ments are par­tic­u­lar­ly ea­ger to take ad­van­tage of a mod­el that now match­es their through­put. Since the re­lease, we have seen a pos­i­tive cus­tomer re­sponse to this pro­gram and we en­cour­age any­one who is in­ter­est­ed in adopt­ing the Berke­ley Lights Plat­form to reach out to us to sched­ule a per­son­al­ized con­sul­ta­tion to un­der­stand which ac­cess mod­el, pur­chase or sub­scrip­tion, best suits their needs.

Reach out to the ex­pert to learn more:

John Proc­tor, PhD
SVP An­ti­body Ther­a­peu­tics at Berke­ley Lights

*TechAc­cess sub­scrip­tions are cur­rent­ly avail­able in se­lect re­gions.
For re­search use on­ly. Not for use in di­ag­nos­tic pro­ce­dures.