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.

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.