It was late last year when the biotech Green­Light Bio­sciences inked a deal with CD­MO gi­ant Sam­sung Bi­o­log­ics to man­u­fac­ture its mR­NA Covid-19 vac­cine. Now, as Sam­sung pumps more mon­ey in­to its biotech and CD­MO op­er­a­tions, the South Ko­re­an com­pa­ny has com­plet­ed the first com­mer­cial-scale en­gi­neer­ing run for Green­Light’s Covid-19 vac­cine boost­er can­di­date.

Ac­cord­ing to Sam­sung Bi­o­log­ics, Green­Light’s syn­the­sis re­ac­tion had a titer of 12g/L at a com­mer­cial scale and pro­duced 650g of mR­NA. On the back of this test, Green­Light’s Covid boost­er is ex­pect­ed to have da­ta lat­er this year, with man­u­fac­tur­ing at a com­mer­cial scale start­ing soon af­ter.

In an in­ter­view with End­points News, Green­Light CEO An­drey Zarur said the com­pa­ny can it­er­ate its mR­NA plat­form to pro­duce hun­dreds of mR­NA species. That’s been ben­e­fi­cial in its orig­i­nal agri­cul­tur­al busi­ness and is now be­ing ap­plied to its vac­cine can­di­date. Zarur said the plat­form al­lows the com­pa­ny to ad­just and up­date the vac­cine in­stead of stick­ing with a cer­tain spike pro­tein.

“The beau­ty of our plat­form is that once we have that we have en­sured that what­ev­er the lead­ing can­di­date is that we liked at that mi­cro­scop­ic scale is ful­ly scal­able to pro­duce hun­dreds of mil­lions of dos­es very rapid­ly,” he aid. “So, the val­ue of the man­u­fac­tur­ing plat­form it­self gets am­pli­fied, if you will, by the fact that we have this up­stream dis­cov­ery en­gine.”

As for the first en­gi­neer­ing run, Zarur said it went ex­act­ly as planned, adding that the com­pa­ny now has a high-pro­duc­tiv­i­ty process that can run at a mi­cro­gram scale, a gram scale, a 10-gram scale, and now a mul­ti-100-gram scale.

The over­all tech­nol­o­gy trans­fer and scale-up from the lab to Sam­sung’s com­mer­cial fa­cil­i­ty were com­plet­ed in sev­en months, but ac­cord­ing to Zarur, Green­Light’s man­age­ment team has worked with Sam­sung for years — and that last­ing col­lab­o­ra­tion was key in get­ting the process up and run­ning.

“We are in con­ver­sa­tions with sev­er­al oth­er com­pa­nies in terms of oth­ers us­ing our plat­form to man­u­fac­ture their prod­uct. In terms of our part­ner for large scale clin­i­cal and com­mer­cial, right now we’re on­ly talk­ing to Sam­sung,” he said.

Green­Light al­so struck up oth­er part­ner­ships to cre­ate mR­NA vac­cines for oth­er dis­eases. In March, the Serum In­sti­tute of In­dia inked a deal with the biotech to joint­ly de­sign three mR­NA prod­ucts, in­clud­ing a shin­gles vac­cine, for de­vel­op­ment and even­tu­al man­u­fac­tur­ing and com­mer­cial­iza­tion.

While the de­vel­op­ment of the boost­er con­tin­ues, Zarur hopes to have a clin­i­cal study done by the end of the year and have da­ta by ear­ly next year. Zarur al­so plans to work with reg­u­la­to­ry bod­ies in Africa to start a clin­i­cal study on the con­ti­nent as vac­ci­na­tion rates re­main low.

“We are cur­rent­ly ne­go­ti­at­ing with a num­ber of reg­u­la­to­ry au­thor­i­ties in Africa to ini­ti­ate those clin­i­cal stud­ies in Africa. We have re­leased a GMP batch and so we’re re­al­ly just go­ing through the de­tails of the pro­to­col,” he said.

As far as the fu­ture with Sam­sung, Zarur said they have dis­cussed us­ing the plat­form in dif­fer­ent ca­pac­i­ties, main­ly to pro­vide ac­cess to oth­ers who are de­sign­ing nov­el mR­NA ap­proach­es as well as pro­vide greater scal­a­bil­i­ty.

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