Manufacturing roundup: Catalent expands in Singapore; Cambrex completes first phase of $30M NC expansion – Endpoints News

Catal­ent is look­ing to ex­pand its clin­i­cal sup­ply fa­cil­i­ty in Sin­ga­pore.
The $2.2 mil­lion in­vest­ment will grow the fa­cil­i­ty by 31,000 square feet to al­low for 35 new freez­ers to be in­stalled for more ul­tra-low tem­per­a­ture stor­age. The ex­pan­sion will al­so al­low the fa­cil­i­ty to sup­port larg­er pack­ag­ing amounts as well as in­crease the site’s ca­pac­i­ty to han­dle mR­NA vac­cines, and cell and gene ther­a­pies.
“This is the lat­est in a se­ries of in­vest­ments and ex­pan­sions that it has un­der­tak­en to meet the in­creas­ing and di­ver­si­fied de­mands of cus­tomers in their mis­sion to de­vel­op life-chang­ing med­i­cines for both the re­gion and the world,” said Roel de No­bel, Catal­ent’s VP and gen­er­al man­ag­er, of clin­i­cal de­vel­op­ment and sup­ply in the APAC re­gion, in a state­ment.
Cam­brex has com­plet­ed the first phase of a $30 mil­lion ex­pan­sion at its API man­u­fac­tur­ing fa­cil­i­ty in the city of High Point, NC, in the state’s Tri­ad re­gion.
Ac­cord­ing to the com­pa­ny, the new ex­pan­sion will add 30,000 square feet of an­a­lyt­i­cal and chem­i­cal de­vel­op­ment lab­o­ra­to­ries, with the abil­i­ty to ex­pand the head­count by 85 em­ploy­ees. The new lab space is in­tend­ed to sup­port API de­vel­op­ment in the fa­cil­i­ty’s man­u­fac­tur­ing area.
With the grow­ing num­ber of ther­a­pies in clin­i­cal de­vel­op­ment and trend to­ward more tar­get­ed ther­a­peu­tics, in­clud­ing or­phan drugs, this ex­pan­sion is prepar­ing Cam­brex to sup­port the grow­ing de­mand for small-scale API man­u­fac­tur­ing,” said Tom Loe­wald, CEO of Cam­brex, in a state­ment.
Ac­cord­ing to Cam­brex, the sec­ond phase of the ex­pan­sion is cur­rent­ly on­go­ing and will dou­ble the man­u­fac­tur­ing ca­pac­i­ty at the High Point fa­cil­i­ty. The sec­ond phase will con­tain man­u­fac­tur­ing suites with re­ac­tors that can pro­duce up to 2,000 liters of prod­uct.
As the mon­key­pox out­break con­tin­ues, HHS is al­so step­ping up its con­tract awards for vac­cine dis­tri­b­u­tion.
Amerisource­Ber­gen has been award­ed a $19.8 mil­lion con­tract to ex­pand the dis­tri­b­u­tion of the Jyn­neos vac­cine and TPOXX treat­ment from the Strate­gic Na­tion­al Stock­pile.
The con­tract, which goes in­to ef­fect in a few weeks, will al­low Amerisource­Ber­gen to boost its dis­tri­b­u­tion ca­pa­bil­i­ty for up 2,500 ship­ments per week of frozen JYN­NEOS vac­cine and up to 2,500 am­bi­ent tem­per­a­ture ship­ments per week, which can be used for TPOXX.
“We con­tin­ue to do every­thing we can to make the vac­cine and ther­a­peu­tics need­ed to re­spond to mon­key­pox avail­able to ju­ris­dic­tions as quick­ly as pos­si­ble,” said HHS As­sis­tant Sec­re­tary Dawn O’Con­nell, in a state­ment.
HHS said as of Sept. 2 the stock­pile has shipped over 800,000 vials of JYN­NEOS and more than 37,000 cours­es of TPOXX na­tion­wide.
The gov­ern­ment has been step­ping up pro­duc­tion ef­forts of the vac­cine in re­cent weeks as CD­MO Grand Riv­er Asep­tic Man­u­fac­tur­ing re­ceived the con­tract to man­u­fac­ture dos­es of Jyn­neos along with an $11 mil­lion BAR­DA for fill and fin­ish ser­vices.
Man­u­fac­tur­ing gi­ant Lon­za will be work­ing with the mR­NA mak­er Touch­light to boost its DNA of­fer­ings to cus­tomers.
The deal will give Lon­za ac­cess to an ad­di­tion­al source of DNA for its cus­tomers de­vel­op­ing mR­NA ther­a­peu­tics and vac­cines. The deal al­so al­lows Touch­light to gain ac­cess to more cus­tomers for its DNA prod­uct dubbed ‘dog­gy­bone DNA.’
“We are de­light­ed to pro­vide Touch­light cus­tomers with the ben­e­fits of an end-to-end mR­NA of­fer­ing through our col­lab­o­ra­tion with Lon­za. Lon­za is the lead­ing CD­MO in mR­NA man­u­fac­tur­ing and has an es­tab­lished, glob­al mR­NA man­u­fac­tur­ing net­work,” said Touch­light CEO Karen Fall­en, in a state­ment.
Touch­light has been mak­ing ma­jor moves in the past few months as the com­pa­ny inked a non-ex­clu­sive patent li­cense agree­ment with Pfiz­er in June. The deal gives Pfiz­er rights to Touch­light’s prod­uct to man­u­fac­ture and com­mer­cial­ize for mR­NA-based vac­cines and ther­a­peu­tics as well as DNA vac­cines and gene ther­a­pies.
Charles Riv­er has en­tered in­to a deal with non­prof­it Cure AP-4, an or­ga­ni­za­tion start­ed by the fam­i­lies of pa­tients suf­fer­ing from the rare neu­rode­gen­er­a­tive dis­or­der for Adapter-Pro­tein 4 Hered­i­tary Spas­tic Para­ple­gia.
The man­u­fac­tur­ing col­lab­o­ra­tion will see Charles Riv­er, craft plas­mid DNA for Cure AP-4’s Phase I/II gene ther­a­py tri­als against the dis­ease.
Ac­cord­ing to Charles Riv­er, this gene ther­a­py treat­ment will look to counter the root caus­es of AP-4 HSP and is aim­ing to act as a ma­jor treat­ment for the con­di­tion.
“The op­por­tu­ni­ty to work with a group as dri­ven as Cure AP-4 is ex­act­ly why we do the work we do. Play­ing a small but crit­i­cal role in de­liv­er­ing a po­ten­tial­ly trans­for­ma­tive ther­a­py to a se­vere­ly un­der­served pa­tient pop­u­la­tion gives us an in­cred­i­ble sense of pride,” said Charles Riv­er COO Bir­git Gir­shick 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.
The first slice of data has arrived from a dose escalating study of Intellia’s in vivo CRISPR treatment for hereditary angioedema, and it’s a promising first step toward a potential once-and-done therapy.
The CRISPR crew at Intellia $NTLA reported Friday morning that six HAE patients treated with either the low 25 mg dose or the high 75 mg dose of NTLA-2002 experienced a 65% and 92% mean reduction in plasma kallikrein. The low-dose group experienced a 91% reduction in HAE attacks after the drug was used to knock out the KLKB1 gene in liver cells.
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While Moderna has been focused on building out its manufacturing apparatus in North America, Europe and Africa, the company appears to be turning toward Japan for its next act.
According to a report from Nikkei Asia, Moderna CEO Stéphane Bancel said the company would like to build a facility in Japan as well as centralize all processes, including manufacturing, into a single facility.
While no other details on the manufacturing site were offered, such as location and timing, Bancel said the site would ideally manufacture vaccines for Covid-19, flu and other diseases. Endpoints News reached out to Moderna to get more details on the matter but they did not respond by press time.
The Department of Health and Human Services is taking the next step in its campaign to encourage Covid-19 vaccinations. The new fall “We Can Do This” ads move past the initial message to get a vaccine and asks Americans — especially people aged 50 and older — to get an “updated vaccine.”
Updated or bivalent boosters are the newer Pfizer-BioNTech and Moderna vaccines that add Omicron BA.4 and BA.5 components to the original vaccine — the CDC and HHS both recommended the shots earlier this month.
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Although “pay-for-delay” agreements and other egregious generic-blocking tactics may be in the rearview mirror, a new report from the nonprofit I-Mak explains how companies are still looking to protect the next generation of blockbusters with piles of new patents.
While some industry insiders point to a broken system that incentivizes these dozens and dozens of new patents — on average there are 74 granted patents on each of America’s 10 top-selling drugs — drugmakers have filed more than 140 patent applications on average per drug, and about two-thirds of those filings came after the approval.
GSK now has dozens more Zantac lawsuits to contend with.
Plaintiffs on Wednesday filed 88 suits against GSK in Delaware court on behalf of more than 7,000 claimants who allege the popular ranitidine heartburn products caused a range of cancers. Pfizer, Boehringer Ingelheim and Sanofi, which owned Zantac rights at various points in time, were also named in the suit, in addition to Thermo Fisher’s Patheon Manufacturing Services.
As manufacturers continue to invest in facilities throughout Ireland, J&J is looking to get in on the action even more.
The company announced on Friday that its vision subsidiary, Johnson & Johnson Vision Care Ireland, will expand its manufacturing facility in Plassey, Ireland, a suburb of the city of Limerick.
The company is placing a €100 million ($100.2 million) investment in the facility, which includes putting in new manufacturing lines that are fully automated. According to a company spokesperson in an email to Endpoints News, construction on the site has already started and is expected to begin production in 2024.
Novo Nordisk never hesitated in its pursuit of Forma’s sickle cell drug etavopivat. Dating back to the early part of 2021, Novo execs were reaching out to Forma to see if they could work out a collaboration. And from the start, Forma wasn’t much interested in that sort of an alliance.
But things got serious after Forma laid out its update on the program at ASH in early December.
The data were from a small Phase I trial, and Forma concluded:
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In August, Alnylam touted a Phase III success for transthyretin amyloidosis, or ATTR for short, with cardiomyopathy — a disease that causes protein buildup in the heart, so it can’t pump at full capacity. However, Intellia and Regeneron are here to compete, with a therapy that only needs to be dosed once.
In today’s update on part 1 of the study, Intellia said that its therapy, known as NTLA-2001, reduced mean serum transthyretin (the protein that builds up in the heart) by 93% and 92% in patients who got either a 0.7 mg/kg or 1.0 mg/kg dose of the therapy, respectively.
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