Gen­er­a­tion Bio is look­ing to move the field of gene ther­a­py in­to the fu­ture, and thinks it has a man­u­fac­tur­ing process in place that will al­low enough scale for broad dis­ease in­di­ca­tions. Now, all it needs is a plant to put those large-scale am­bi­tions in­to ac­tion.

Gen­er­a­tion signed a lease on a new 104,000-square-foot fa­cil­i­ty in Waltham, MA, set to be­come op­er­a­tional in 2023. The fa­cil­i­ty will be avail­able for pre­clin­i­cal and clin­i­cal de­vel­op­ment for its lead he­mo­phil­ia A pro­gram.

The shell is set up, and it has all the ad­van­tages that come with a large, in­dus­tri­al site that doesn’t al­ways fit in­side the crowd­ed in­fra­struc­ture of Cam­bridge, the fifth most dense­ly pop­u­lat­ed city in the US. But the Waltham site is just eight miles away from Gen­er­a­tion’s Kendall Square head­quar­ters, and the abil­i­ty to pro­vide greater con­nec­tiv­i­ty be­tween the two sites was im­por­tant to the team as it rolls out a brand-new man­u­fac­tur­ing process.

The lease will cost $104 mil­lion over a 12-year pe­ri­od, and Gen­er­a­tion will in­vest $45 mil­lion over the next two years in­to the site. The team will still use CD­MOs be­fore and af­ter the site is up and run­ning to en­sure re­dun­dan­cy and se­cure ad­di­tion­al ccD­NA sup­ply, but CEO Ge­off Mc­Do­nough said the team wants to re­ly on greater flex­i­bil­i­ty and greater fi­nan­cial lever­age that comes with its own sup­ply chain in house.

The holdup sur­round­ing tra­di­tion­al man­u­fac­tur­ing is scale. For ex­am­ple: there are 200 mil­lion peo­ple world­wide with he­mo­phil­ia A. “You just don’t have enough scale to get to (them),” Mc­Do­nough said. “This move al­lows us to con­sid­er ad­dress­ing those very large pop­u­la­tions.”

Gen­er­a­tion Bio is tout­ing what it’s call­ing a game-chang­ing man­u­fac­tur­ing process called rapid en­zy­mat­ic syn­the­sis — oth­er­wise known as RES — that can speed clin­i­cal man­u­fac­tur­ing of its non-vi­ral gene ther­a­pies from 28 days down to one.

With more flex­i­bil­i­ty on its man­u­fac­tur­ing runs, Gen­er­a­tion’s team is tar­get­ing in­fec­tious dis­eases and oth­er larg­er in­di­ca­tions, in ad­di­tion to its cur­rent work in rare ge­net­ic dis­eases. The com­pa­ny has been work­ing on two lead pro­grams for he­mo­phil­ia A and phenylke­tonuria (PKU). Wil­son dis­ease and Gauch­er dis­ease are al­so on the list

“For first gen­er­a­tion AAV man­u­fac­tur­ing, mak­ing that con­struct can on­ly be done in a cell sys­tem,” Mc­Do­nough said in a call with End­points News Tues­day. “Since you’re mak­ing it with cap­sid, you’re lim­it­ing your­self to a few thou­sand liters of prod­uct, and with that, very few pa­tients you can help, some­where around 10,000. We’ve al­ways had this idea of ‘look, our drug sub­stance is DNA, there are oth­er ways to make DNA in­clud­ing en­zy­mat­i­cal­ly, where you take the plas­mid in, and you un­der­go a fi­nite set of en­zy­mat­ic trans­for­ma­tions, and then you get that drug sub­stance, which is closed end­ed DNA com­ing out.”

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.