Manufacturing roundup: Cytiva partners with Aurisco to build site for … – Endpoints News

The Chi­nese CD­MO Au­risco is link­ing up with Cy­ti­va to build a plat­form to pro­duce oligonu­cleotides.
Dubbed the Oglio Flex­Fa­cotry plat­form, the com­pa­nies tout the line as a faster and more ef­fi­cient way to make oligonu­cleotides.  It will be the first of three new com­mer­cial man­u­fac­tur­ing lines that Au­risco is build­ing in Yangzhou, Chi­na. The site will be plan­ning to pro­duce 200 kilo­grams of oligonu­cleotides an­nu­al­ly.
In an email to End­points News, a Cy­ti­va spokesper­son said that Au­risco and Cy­ti­va have been col­lab­o­rat­ing since 2021.
“In this new col­lab­o­ra­tion, Cy­ti­va will of­fer a com­pre­hen­sive en­ter­prise so­lu­tion to Au­risco. It in­cludes an Oli­go Flex­Fac­to­ry plat­form and var­i­ous tech­ni­cal and ser­vice sup­port, such as process de­sign of the man­u­fac­tur­ing site, as well as life-cy­cle project man­age­ment,” the spokesper­son said.
They added that the size of the fa­cil­i­ty would be around 2,500 square me­ters, with the phase one in­vest­ment be­ing in the “dozens of mil­lions” of dol­lars. The fa­cil­i­ty is sched­uled to be com­plet­ed in the first quar­ter of 2024 and will hire around 100 peo­ple.
The API man­u­fac­tur­er that spun off from Sanofi, Eu­roAPI, is in­vest­ing in one of its fa­cil­i­ties in France.
Eu­roAPI’s board ap­proved a €40 mil­lion ($43.3 mil­lion) in­vest­ment for new tech­nol­o­gy ded­i­cat­ed to vi­t­a­min B12 pro­duc­tion at its man­u­fac­tur­ing site in Saint-Aubin-lès-El­beuf, France. The in­vest­ment is de­signed to boost its man­u­fac­tur­ing ca­pac­i­ty by 2025. The in­vest­ment al­so comes with fi­nan­cial sup­port from the French gov­ern­ment to the tune of €7.9 mil­lion ($8.5 mil­lion).
This ex­pan­sion, along with oth­er in­vest­ments at this site, plans to boost pro­duc­tion by 60% with the new tech­nol­o­gy cut­ting down on waste and wa­ter con­sump­tion.
“This key in­vest­ment in France will en­able us to in­crease our pro­duc­tiv­i­ty in a dy­nam­ic vi­t­a­min B12 mar­ket, grow­ing at 6-7% per an­num. It will al­so in­crease the lev­el of dif­fer­en­ti­a­tion of our port­fo­lio while im­ple­ment­ing tech­nol­o­gy for green­er pro­duc­tion,” said Karl Rot­thi­er, Eu­roAPI’s CEO, in a state­ment.
Vi­ral­gen, a mem­ber of the Bay­er group, has got­ten the cGMP cer­ti­fi­ca­tion to man­u­fac­ture hu­man med­i­c­i­nal prod­ucts at its site in San Se­bas­t­ian, Spain.
The ap­proval came from the Span­ish Agency for Med­i­cines and Med­ical De­vices, a part of the EMA net­work. Vi­ral­gen now has two sites in San Se­bas­t­ian op­er­at­ing and has 300,000 square feet of space and can pro­duce 2,000 liters of prod­uct.
The CD­MO will be pro­duc­ing re­com­bi­nant ade­no-as­so­ci­at­ed (rAAV) gene ther­a­pies. Vi­ral­gen is al­so plan­ning to open more man­u­fac­tur­ing and de­vel­op­ment space at the end of Q1 2023. Vi­ral­gen is al­so look­ing to ex­pand its part­ner­ship ca­pa­bil­i­ties and works with com­pa­nies that are en­ter­ing Phase III stud­ies and seek­ing ap­provals for com­mer­cial­iza­tion.
“Be­ing a ful­ly in­te­grat­ed CD­MO, we of­fer a con­tin­u­um of prod­ucts and ser­vices, in­clud­ing process, an­a­lyt­i­cal de­vel­op­ment, sta­bil­i­ty stud­ies and fill and fin­ish for all types of rAAV serotypes. This can sig­nif­i­cant­ly short­en the time to mar­ket, help with the pre­dictable cost of goods and re­duce the wait­ing time ex­pe­ri­enced by pa­tients who have run out of op­tions and hope for break­through treat­ments,” said Jim­my Van­hove, CEO of Vi­ral­gen, in a state­ment.
The Chas­ka, MN-based CD­MO Lifecore Med­ical has grabbed it­self some cash to start the year.
The CD­MO net­ted $38.75 mil­lion in a pri­vate place­ment, it an­nounced on Mon­day, sell­ing 38,750 shares.
“We ex­pect to use the pro­ceeds of the in­vest­ment to sup­port both our work­ing cap­i­tal and cap­i­tal ex­pen­di­ture re­quire­ments to de­liv­er on our in­creased near- and longer-term cus­tomer de­mands while we fo­cus on ad­di­tion­al cost sav­ings, dri­ving free cash flow and di­vest­ing our non-CD­MO as­sets,” said Lifecore CEO James Hall in a state­ment.
The pri­vate place­ment was led by Le­gion Part­ners and 22NW Fund with par­tic­i­pa­tion from Wyn­nefield Cap­i­tal, Cove Street Part­ners and 325 Cap­i­tal.
Sov­er­eign Phar­ma­ceu­ti­cals, a sub­sidiary of Alo­ra Phar­ma­ceu­ti­cals, has pur­chased a man­u­fac­tur­ing fa­cil­i­ty in Fort Worth, TX, from Monarch PCM.
The ac­qui­si­tion, which closed on Jan. 4, in­cludes all of Monarch’s equip­ment at the site along with a leased space, which is in the same com­plex as Sov­er­eign’s main fa­cil­i­ty. This move will al­low Sov­er­eign to ex­pand its cur­rent op­er­a­tions once the site is ren­o­vat­ed, and add 48 em­ploy­ees to Sov­er­eign’s ranks.
Sov­er­eign now has around 60,000 square feet of man­u­fac­tur­ing space, bring­ing its to­tal foot­print to over 300,000 square feet.
“The ac­qui­si­tion of the Monarch as­sets will sig­nif­i­cant­ly im­prove our abil­i­ty to man­u­fac­ture sol­id, se­mi-sol­id and liq­uid man­u­fac­tur­ing in large vol­umes,” ac­cord­ing to Art Deas, CEO of Alo­ra, in a state­ment.
The In­di­an con­tract re­search and man­u­fac­tur­ing com­pa­ny Sai Life Sci­ences has inked a 5-year agree­ment with Schrödinger to es­tab­lish a re­search lab­o­ra­to­ry in the city of Hy­der­abad, In­dia.
The lab, which is be­ing built on Sai’s R&D cam­pus in Hy­der­abad, will be ded­i­cat­ed to re­search­ing med­i­c­i­nal and syn­thet­ic chem­istry, in vit­ro bi­ol­o­gy and oth­er chem­i­cal process­es to de­vel­op can­di­dates. Schrödinger will pro­vide tech­no­log­i­cal plat­forms for the lab.
The lab is sched­uled to open in April of this year and staff around 75 peo­ple, with Sai ac­tive­ly re­cruit­ing po­si­tions.
The Cana­da-based Eu­rofins CD­MO Alpho­ra is re­lo­cat­ing its ac­tive phar­ma­ceu­ti­cal in­gre­di­ent de­vel­op­ment lab­o­ra­to­ries with­in the city lim­its of Mis­sis­sauga, On­tario, Cana­da.
The 56,000-square-foot build­ing will house Eu­rofins’ API R&D lab, along with its an­a­lyt­i­cal ser­vices team. The new site has the ca­pac­i­ty for sev­er­al re­search and de­vel­op­ment process­es and new of­fice space while ex­pand­ing its over­all lab space.
The site is al­so part of the CD­MO’s vi­sion for a 14-acre cam­pus at a near­by re­search park where the com­pa­ny plans to es­tab­lish more man­u­fac­tur­ing ser­vices, in­clud­ing a new plant to pro­duce APIs, which plans to come on­line in the mid­dle of this year.
As­tra Biosep­a­ra­tions, a pro­duc­er of pu­rifi­ca­tion and biosep­a­ra­tion tech, has ac­quired Delta Pre­ci­sion for an undis­closed amount.
Delta is a man­u­fac­tur­er of chro­matog­ra­phy columns that are used by phar­ma­ceu­ti­cal and biotech com­pa­nies.
The move will al­so al­low As­trea to ex­pand its prod­uct of­fer­ings to in­clude a “full range” of chro­matog­ra­phy columns for bio­man­u­fac­tur­ing and add to its port­fo­lio of resins, reusable columns and oth­er prod­ucts.
“This is a high­ly strate­gic move for us, al­low­ing us to of­fer a full range of in­dus­try-lead­ing pu­rifi­ca­tion and sep­a­ra­tion tools,” said As­trea Biosep­a­ra­tions CEO Ter­ry Pizzie, in a state­ment.
WuXi AppTec sub­sidiary WuXi STA has start­ed op­er­a­tions on a new con­tin­u­ous man­u­fac­tur­ing line for oral solids at its fa­cil­i­ty in WuXi city, Chi­na.
Ac­cord­ing to the com­pa­ny, this new man­u­fac­tur­ing line will pro­vide a high­er yield of oral solids as well as short­ened time­lines for get­ting to mar­ket.
Minzhang Chen, the CEO of WuXi STA, said in a state­ment that this line is the first con­tin­u­ous man­u­fac­tur­ing line for oral solids at its site in WuXi city.
Transforming the US healthcare system will be complex, but an emerging class of tech-enabled providers are poised to support a breakthrough. Learn why the move to value-based care offers a potentially huge market opportunity, despite being in its early stages.
The unsustainable nature of US healthcare spending has long been a widely accepted fact, and expenditures touched 19.7% of GDP in 2020. The country now spends an estimated $12,318 per person on healthcare annually – far above Germany, the next biggest spender at $7,382 per head.
Researchers are already using gene editing to tackle rare inherited diseases. But in a new paper, researchers use that tool in mice to treat the leading cause of death in the world: heart disease.
In a study published in Science Thursday, Eric Olson, Simon Lebek and colleagues from UT Southwestern modified a gene in mice that encodes an enzyme that, when chronically overactive, can lead to an array of heart diseases. The enzyme, known as CaMKII𝛿, regulates heart function, and is one form of CaMKII, which plays important regulatory roles in many organs in the body.
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Verily, spun out of Google parent Alphabet, is laying off about 15% of its employees, shaking up the executive leadership and narrowing its focus, the company confirmed to Endpoints News.
Co-founder Jessica Mega and health platforms president Vivian Lee have left the company, according to LinkedIn updates to their profiles, as first reported by STAT News. Jordi Parramon, president of the company’s devices unit, is also leaving, according to an internal memo from CEO Stephen Gillett.
Three contract organizations based near the capital of Ohio are starting the year with a multimillion-dollar deal.
The science and technology company Battelle, contract researcher AmplifyBio and CDMO Andelyn Biosciences have netted an eight-year, $149 million indefinite delivery, indefinite quantity contract from the National Institute of Neurological Disorders and Stroke to help advance therapies for treat neurological conditions.
AstraZeneca is retiring Lumoxiti, its third-line treatment for a rare type of blood cancer called hairy cell leukemia (HCL), the company confirmed to Endpoints News on Thursday.
The drug will be permanently discontinued in the US as of July 2023, in part due to competition from rivals, a spokesperson said in an email. The decision “does not reflect any new concerns about the safety or efficacy” of Lumoxiti, but rather “an evaluation of the utilization” of the drug and “the availability of other treatments that are more widely prescribed.”
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During her residency, dermatologist Misty Eleryan noticed that patients of color were often being misdiagnosed or receiving delayed diagnoses for their skin conditions. Part of the reason why, she said, begins with a lack of representation in textbooks.
She and a team of doctors are on a mission to change that — and this year, dermatology giant Galderma is joining the cause.
Eleryan and fellow dermatologist Adam Friedman co-edited “The Full Spectrum of Dermatology: A Diverse and Inclusive Atlas,” a database of more than 800 images of commonly diagnosed conditions across various skin tones published by healthcare communications company SanovaWorks. The original print version was published in 2021 and updated last year, and thanks to funding from Galderma, the group has launched an online database.
Martha Stewart means business in Pfizer and BioNTech’s new TV ad encouraging updated Covid booster shots. The commercial opens with Stewart noisily sharpening a long sword on a large electric wheel knife grinder. She says, “You know that unwelcome guest everyone wishes would just leave already? That’s Covid-19.”
She goes on to say that’s why she got the updated booster that protects against the Omicron variant, as she chops off the head of a pineapple and then slings the sword onto her shoulder while revealing a blue Band-Aid on her upper arm.
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SAN FRANCISCO — In the still-unfolding chronicle of Covid-19 vaccine history, March 16, 2020 might bear an entry on how the NIH dosed the first volunteer with Moderna’s mRNA vaccine. Much less remembered, though, is the fact that on the same day, a then-11-year-old Chinese vaccine maker received the greenlight from regulators in China to begin its own first-in-human trial for an adenoviral vector-based shot.
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The World Health Organization is issuing an alert for batches of two cough syrups manufactured by an Indian company that were found to be contaminated.
The contaminated products, Ambronol syrup and DOK-1 Max syrup, were identified in Uzbekistan and reported to the WHO on Dec. 22 of last year. According to the WHO, an analysis conducted by Uzbekistan’s Ministry of Health identified “unacceptable amounts of diethylene glycol and /or ethylene glycol.” The WHO lists Marion Biotech, based in Uttar Pradesh, India, as the manufacturer.
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The University of Kansas
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