Manufacturing roundup: WuXi STA unveils new facility; Purdue University nets $3M grant for zero-waste pharma manufacturing – Endpoints News

CD­MO WuXi STA has been on the move re­cent­ly by break­ing ground on a fa­cil­i­ty in the US, and the com­pa­ny is show­ing no signs of stop­ping its ex­pan­sion dri­ve.
The com­pa­ny an­nounced that it has opened a new ster­ile lipid nanopar­ti­cle man­u­fac­tur­ing site at its cam­pus in the city of WuXi, Chi­na. The fa­cil­i­ty has a mod­u­lar lay­out, al­low­ing for flex­i­bil­i­ty in the man­u­fac­tur­ing process, and can pro­duce 10 to 50 liters per batch.
“We are pleased to sup­port our part­ners with this state-of-the-art LNP fa­cil­i­ty to meet the grow­ing de­mand for ad­vanced in­jec­tion dosage forms. We will con­tin­ue to ex­pand our CRD­MO plat­form’s ca­pac­i­ty and ca­pa­bil­i­ties to en­able our part­ners to ac­cel­er­ate more in­no­v­a­tive drugs to mar­ket for pa­tients world­wide,” said WuXi STA CEO Minzhang Chen in a state­ment.
Re­searchers at Pur­due Uni­ver­si­ty have se­cured a $3 mil­lion grant from the Na­tion­al Sci­ence Foun­da­tion to in­ves­ti­gate cost-ef­fec­tive, ze­ro-waste ini­tia­tives for phar­ma man­u­fac­tur­ing op­er­a­tions.
Ac­cord­ing to the uni­ver­si­ty, cur­rent man­u­fac­tur­ing can cre­ate a sig­nif­i­cant amount of un­used med­i­cines and tox­ic waste, caus­ing en­vi­ron­men­tal dam­age and re­duc­ing man­u­fac­tur­ers’ prof­its.
“Our project is fo­cused on cre­at­ing a large-scale frame­work and cy­ber­in­fra­struc­ture that can help man­u­fac­tur­ing net­works to per­form more sus­tain­ably. We’ll start our proof of con­cept with the phar­ma­ceu­ti­cal in­dus­try, giv­en its high im­pact on the Amer­i­can man­u­fac­tur­ing sys­tem dur­ing Covid,” said Shwe­ta Singh, project leader and as­so­ciate pro­fes­sor of Agri­cul­tur­al and Bi­o­log­i­cal En­gi­neer­ing and En­vi­ron­men­tal and Eco­log­i­cal En­gi­neer­ing, in a state­ment.
The project will aim to build a “cir­cu­lar econ­o­my de­sign com­pu­ta­tion­al tool,” which will help com­pa­nies reuse re­sources while al­so re­duc­ing the flow of waste, and stands in stark con­trast to the more lin­ear forms of pro­duc­tion in the in­dus­try.
The mod­el has al­ready been test­ed in agrar­i­an-based set­tings, and Singh’s team is work­ing with part­ners in the in­dus­try to de­vel­op and test the al­go­rithms.
The team will al­so work to de­vel­op a pric­ing al­go­rithm as well for the re­cy­cling of waste med­i­cines for man­u­fac­tur­ing.
The joint ven­ture be­tween Re­silience and MD An­der­son to cre­ate a man­u­fac­tur­ing site for cell ther­a­pies has pulled in a new part­ner.
Man­u­fac­tur­ing tech­nol­o­gy com­pa­ny Ori Biotech has part­nered up with the Cell Ther­a­py Man­u­fac­tur­ing Cen­ter (CTMC), the joint ven­ture that aims to cre­ate new cell ther­a­pies to fight can­cer. The col­lab­o­ra­tion will set its sights on in­dus­tri­al man­u­fac­tur­ing process­es for cell ther­a­pies.
Ac­cord­ing to Ori, the part­ner­ship will in­clude com­bin­ing its tech­nol­o­gy plat­form with the man­u­fac­tur­ing cen­ter’s ca­pa­bil­i­ties. While the part­ner­ship has ze­roed in on work­ing on one cell ther­a­py now, it plans to work on oth­er Car-T process­es and de­ter­mine its “tech­ni­cal fea­si­bil­i­ty.”
The part­ner­ship will al­so al­low the CTMC to gain pre-com­mer­cial ac­cess to Ori’s tech­nol­o­gy.
“Ori and CTMC have specif­i­cal­ly part­nered with the goal of in­creas­ing pa­tient ac­cess to po­ten­tial­ly life-sav­ing cell ther­a­pies. This part­ner­ship will have a con­sid­er­able im­pact on the cell ther­a­py field by im­ple­ment­ing in­no­v­a­tive, dig­i­tal­ly en­abled process dis­cov­ery and au­to­mat­ed man­u­fac­tur­ing so­lu­tions,” said Ja­son Fos­ter, Ori Biotech’s CEO, in a state­ment.
Ever­stone Cap­i­tal has ac­quired a con­trol­ling stake in the man­u­fac­tur­ing com­pa­ny Soft­gel Health­care. Soft­gel, an In­di­an-based dosage form man­u­fac­tur­ing op­er­a­tion, cre­ates over-the-counter phar­ma­ceu­ti­cal prod­ucts — main­ly pro­bi­otics and soft gelatin cap­sules.
Ac­cord­ing to Sin­ga­pore-based Ever­stone Cap­i­tal, the ac­qui­si­tion will aim to build up Soft­gel and pro­vide the com­pa­ny with more re­sources. The fi­nan­cial terms of the deal were not dis­closed.
Soft­gel, part of the Madras Phar­ma Group, al­so main­tains eight man­u­fac­tur­ing sites and R&D op­er­a­tions.
“The com­pa­ny, with its strong R&D ca­pa­bil­i­ties and abil­i­ty to man­u­fac­ture prod­ucts in ad­vanced dosage forms, is well po­si­tioned to be a glob­al leader in the CD­MO seg­ment. We be­lieve that Ever­stone’s val­ue cre­ation play­book will help SH­PL re­al­ize its glob­al goals and pro­pel the com­pa­ny in­to its next phase of growth,” said Sameer Sain, Ever­stone Group CEO in a state­ment.
If you work in cancer biomarker and target research, chances are you use data from The Cancer Genome Atlas (TCGA) to help you make discoveries. This comprehensive and coordinated effort helps accelerate our understanding of the molecular causes of cancer through genomic analyses, including large-scale genome sequencing. TCGA covers 33 types of cancer with multi-omics data, such as RNA-seq, DNA-seq, copy number, microRNA-seq, and others. Detailed analyses of individual TCGA datasets, as well as pan-cancer meta-analysis, have revealed new cancer subtypes with important therapeutic implications. A key value here is the TCGA metadata.  TCGA samples include extensive clinical metadata for diverse cancers. However, inconsistent terminology and formatting limit the utility of these data for pan-cancer analyses.
Earlier this year, Jonathan Epstein and other scientists at Penn published a paper in Science that spelled out the intriguing results of a mouse study. Using CD-5 targeted lipid nanoparticles, the tiny vehicles used to carry messenger RNA, they were able to reprogram T lymphocytes into CAR-Ts in vivo, in the body. Trained to recognize fibrotic cells specifically in the heart, the scientists involved were able to restore cardiac function in mice.
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“Seinfeld” actor Jason Alexander takes a turn as a guardian angel in a new Sanofi campaign to encourage flu vaccinations.
Known for his funny, offbeat George Costanza character, Alexander takes on a sweeter though still humorous role protecting his charge from “life’s little disasters.” As he catches falling pigeon poop in his hat, swaps expired milk and fends off insects, he compares his guardian angel role to flu immunization.
Illinois-based pharma company Akorn, which filed for bankruptcy back in 2020, has now agreed to pay $7.9 million to resolve allegations that it caused Medicare to pay false claims related to generic drugs that had already transitioned to OTC products.
As part of the settlement, the DOJ said Akorn admitted to delaying its conversion of certain generics — the NSAID pain drug diclofenac, and the antihistamines olopatadine and azelastine — from prescription-only to OTC status.
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While CMS drug price negotiations won’t actually kick off until 2026, a group of more than two dozen Republican senators is already raising questions about how this new law will be implemented.
The partisan law (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations but mandatory inflation-related rebates that will begin next year, as well as million-dollar fines for noncompliance.
AstraZeneca’s latest campaign spotlights the ongoing — but often forgotten — struggles of immunocompromised people in the Covid-19 pandemic.
The “Up the Antibodies” campaign includes celebrities along with everyday patients who live with conditions that prohibit the return to normal activities, such as going out without masks or mixing with large groups indoors, that many non-compromised people in the US are now doing.
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As Fujifilm has been investing heavily in its CDMO arm for over a year, one of its major projects is now getting off the ground.
The Japanese manufacturer announced that it has broken ground on an expansion project at its site in the city of Hillerød, Denmark. The expansion, which was first announced in June, is part of a $1.6 billion project to expand the cell culture production capabilities in Denmark and at another facility in Texas.
The 21st Century Cures Act, passed during the Obama administration in 2016, featured a whole host of changes that were meant to help the biotech sector and help the FDA adapt to some newer advancements in the development of drugs.
One of the provisions in the bill requires the FDA to produce a list of alternative or streamlined mechanisms to help combo product developers better comply with current good manufacturing practice (cGMP) requirements.
Over the past few days, the Biden administration has been focused on new science efforts, particularly around cancer, and growing biomanufacturing in the US.
On Wednesday, the White House held a summit on biotech and biomanufacturing, revealing what it will spend to boost these efforts.
Brian Deese, director of the National Economic Council, said that the administration has been focused on a modern industrial strategy by placing public funds in efforts that invest in infrastructure and secure supply chains. He also said that the focus of the initiative is to increase the domestic manufacturing of APIs to limit the dependence on foreign suppliers as well as increase the domestic manufacturing capacity in general and create jobs.
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