There’s a bot­tle­neck in man­u­fac­tur­ing right now, and per­haps the cat­e­go­ry that is the best rep­re­sen­ta­tive of the is­sue is cell and gene ther­a­py. Sev­er­al com­pa­nies are try­ing dif­fer­ent things to ad­dress the is­sue, but Mul­ti­ply Labs has en­list­ed some CD­MO pow­er­hous­es on its path to­ward the au­toma­tion of the process.

Cy­ti­va and the Uni­ver­si­ty of Cal­i­for­nia-San Fran­cis­co were al­ready mem­bers of the ro­bot­ic cell ther­a­py man­u­fac­tur­ing con­sor­tium Mul­ti­ply, found­ed in 2021. Last week, it was an­nounced that Ther­mo Fish­er Sci­en­tif­ic and Charles Riv­er Lab­o­ra­to­ries have joined the team to help de­vel­op a cGMP-com­pli­ant sys­tem that can make gene-mod­i­fied cell ther­a­pies at an in­di­vid­ual scale.

I sat down with Mul­ti­ply’s CEO and co-founder Fred Pari­et­ti to talk more about this. Here’s our con­ver­sa­tion.

Con­grat­u­la­tions on this news!

We’re very ex­cit­ed, it’s very good to be able to an­nounce these new part­ners, but al­so show a lit­tle bit more of the ro­bots. When you see them in per­son, it’s al­ways a lit­tle more im­pres­sive, but right now, it feels good to do an an­nounce­ment.

Can you walk me through the ear­ly stages of Mul­ti­ply and the con­sor­tium?

We are all ro­bot­ics peo­ple … 95% of us. And when I say ro­bot­ics peo­ple, I say me­chan­i­cal en­gi­neers and com­put­er sci­en­tists. Some of us were at self-dri­ving com­pa­nies. Oth­er peo­ple were at ro­bot­ic arm com­pa­nies. And so we saw a trend to­ward spe­cial­ized med­i­cine … and as ro­bot­ics peo­ple, we be­lieve very strong­ly that the on­ly way to do that ef­fi­cient­ly is with cut­ting edge au­toma­tion.

That’s how we got in the cell ther­a­py space, and as ro­bot­ics peo­ple with GMP ex­pe­ri­ence … which is very very unique. Very few ro­bot­ics peo­ple ac­tu­al­ly know whaat GMP man­u­fac­tur­ing is … And as ro­bot­ics peo­ple, we knew in cell ther­a­py, the process is so im­por­tant.

What does this mean in prac­ti­cal terms? Phar­ma com­pa­nies and large CD­MOs are used to us­ing state-of-the-art equip­ment. These are the in­stru­ments they brought to GMP … and so if we start­ed do­ing this from all scratch, it would be a gi­gan­tic amount of un­knowns. First of all, no­body knows if the cells are go­ing to work in your equip­ment. Sec­ond, you are back to square one from the point of view of reg­u­la­to­ry stan­dards. And that’s the rea­son we de­cid­ed to go with a very mod­u­lar ap­proach, and why you’re see­ing all these part­ners that are the man­u­fac­tur­ers of the cur­rent state of the GMP in­stru­ments. Our ro­bots talk to all of these mod­ules.

Where in the process did you de­cide to meet man­u­fac­tur­ing where it al­ready was? Was that ear­ly on?

It was right from the start. Right from the start when we start­ed work­ing on cell ther­a­py, it was very clear that us­ing proven GMP in­stru­ments was go­ing to be es­sen­tial if we want to make it hap­pen. It’s a very unique en­gi­neer­ing ap­proach in which we use what’s proven now, and we add a lay­er of in­for­ma­tion on top of it, but with­out sub­trac­tion. With­out forc­ing the cells to work in a new con­di­tion, be­cause you don’t know how they’re go­ing to re­act.

I know the com­pa­ny start­ed in 2021…

The con­sor­tium start­ed then. The com­pa­ny has been around since 2016. In the first years, we fo­cused most­ly on small mol­e­cules. Now we do both small mol­e­cule man­u­fac­tur­ing and ro­bot­ic based cell ther­a­py man­u­fac­tur­ing.

With Covid-19 putting sup­ply chain is­sues and bot­tle­necks on dis­play for the lay­man to see on a glob­al dis­play, what is on your mind when you’re tak­ing steps to solve this prob­lem and then you see it thrust on­to the glob­al stage?

Covid was kind of like a turn­ing point, evening though we don’t work with any­thing that’s strict­ly Covid-re­lat­ed. Covid was ba­si­cal­ly a change in mind­set for the in­dus­try. First of all, it showed that phar­ma­ceu­ti­cal man­u­fac­tur­ing is crit­i­cal, and you bet­ter think about it. Right? And think about very good, scal­able, crit­i­cal so­lu­tions. We don’t even need to pitch peo­ple on this right now, they reach out to us and say we want to au­to­mate.

To be more re­silient, now every ma­jor phar­ma and CD­MO is mak­ing sup­ply chain in at least three con­ti­nents: Asia, North Amer­i­ca and Eu­rope. I think this is kind of like the base­line. Be­fore, I think peo­ple were try­ing to ad­dress the glob­al mar­ket with a sin­gle lo­ca­tion, but right now, I think that’s not pos­si­ble. It’s per­fect for a ro­bot­ics ap­proach, be­cause we can ship and in­stall the ro­bots any­where on the plan­et, and they in­stant­ly make those fa­cil­i­ties more ef­fi­cient. From that point of view, I think ro­bot­ics is a very good an­swer to our sup­ply chain prob­lems.

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

While Massachusetts-based Charles River Laboratories has been on an acquisition spree, they are not against planting their flag. The latest move by the company sees them crossing the pond to establish a manufacturing site in the UK.

The company on Tuesday opened its cell and gene therapy manufacturing center at Bruntwood SciTech’s Alderley Park in Cheshire, United Kingdom. The expansion follows Charles River’s acquisition of Cognate BioServices and Cobra Biologics in 2021 for $875 million. Cognate is a plasmid DNA, viral vector and cell therapy CDMO.

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”