An impor­tant mile­stone for many biotech star­tups is when the com­pa­ny evolves from pure­ly R&D work to actu­al­ly man­u­fac­tur­ing its inno­va­tions. Kan­vas proud­ly hit this mile­stone last year and we’re excit­ed to share an update on our lat­est capa­bil­i­ties, along with some lessons learned.

First, we’re open­ing a new good man­u­fac­tur­ing prac­tices (GMP) lab in South San Fran­cis­co! The lab is designed to accel­er­ate our man­u­fac­tur­ing capa­bil­i­ties for live bio­ther­a­peu­tic prod­ucts (LBPs) and being built to meet clin­i­cal-grade pro­duc­tion stan­dards. This will allow us to seam­less­ly tran­si­tion from R&D and process devel­op­ment into GMP man­u­fac­tur­ing to sup­port Phase 1 and 2 clin­i­cal tri­als of our lead drug can­di­date KAN-001, which is an LBP demon­strat­ing sig­nif­i­cant poten­tial to improve out­comes for can­cer patients who require immune check­point inhibitors. 

The lab spans ~4,000 square feet, with ded­i­cat­ed areas for upstream and down­stream pro­cess­ing, and qual­i­ty con­trol labs. It’s unique in that the prod­uct is main­tained under anaer­o­bic con­di­tions end-to-end, from Mas­ter cell bank start­ing mate­r­i­al all the way to Drug prod­uct in cap­sules. Key equip­ment includes state-of-the-art anaer­o­bic fer­men­ta­tion sys­tems, tan­gen­tial flow fil­tra­tion, lyophiliz­ers, encap­su­la­tion work­flow for drug prod­uct man­u­fac­tur­ing and ana­lyt­i­cal tools tai­lored for com­plex micro­bial con­sor­tia. Our goal is for the lab to become a cen­ter of excel­lence for LBP man­u­fac­tur­ing, serv­ing both Kan­vas’ inter­nal pipeline and exter­nal partnerships. 

We expect the facil­i­ty to become oper­a­tional in the com­ing weeks, with ini­tial GMP man­u­fac­tur­ing runs sched­uled short­ly thereafter. 

So far, one of our biggest learn­ings has been the crit­i­cal impor­tance of inte­grat­ing process devel­op­ment ear­ly with drug prod­uct design. Unlike tra­di­tion­al bio­log­ics, com­plex LBPs demand unique con­sid­er­a­tions for strain diver­si­ty, via­bil­i­ty and sta­bil­i­ty, and Kan­vas’ abil­i­ty to ensure this under com­plete anaer­o­bic con­di­tions sets us apart. Build­ing our own man­u­fac­tur­ing plat­form cou­pled with its inte­gra­tion with spa­tial imag­ing has rein­forced the val­ue of hav­ing true end-to-end con­trol, from strain iso­la­tion to the final drug product.

Over­all, we’re most excit­ed about gain­ing the abil­i­ty to iter­ate faster, inno­vate on man­u­fac­tur­ing strate­gies, and bring micro­bio­me ther­a­pies to patients with greater speed and pre­ci­sion. By hav­ing full con­trol over qual­i­ty and time­lines, our lab posi­tions Kan­vas to set new indus­try bench­marks for excel­lence and repro­ducibil­i­ty in com­plex co-cul­ture man­u­fac­tur­ing. Addi­tion­al­ly, our pro­pri­etary spa­tial imag­ing tech­nol­o­gy pro­vides unpar­al­leled insight into the health and via­bil­i­ty of each strain with­in a mixed con­sor­tium – capa­bil­i­ties no oth­er micro­bio­me-focused con­tract devel­op­ment and man­u­fac­tur­ing orga­ni­za­tion (CDMO) can match. This enables data-dri­ven process con­trol and ensures con­sis­tent prod­uct qual­i­ty, which is crit­i­cal for clin­i­cal success.

Ulti­mate­ly, we believe Kan­vas’ approach will rede­fine man­u­fac­tur­ing stan­dards for micro­bio­me-based ther­a­peu­tics. By com­bin­ing imag­ing and man­u­fac­tur­ing, we’re not just improv­ing our own drug pipeline, but also pio­neer­ing method­olo­gies that can serve the broad­er biotech com­mu­ni­ty, includ­ing help­ing oth­er com­pa­nies over­come long-stand­ing chem­istry, man­u­fac­tur­ing and con­trols (CMC) chal­lenges in the LBP field.

Final­ly, to sup­port our expand­ing man­u­fac­tur­ing capa­bil­i­ties, we’re hir­ing! Check out open roles here, which include ful­ly onsite, lab-based posi­tions in San Francisco.