Mer­ck KGaA’s Mil­li­pore­Sig­ma has launched a new AAV pro­duc­tion plat­form.

The plat­form will en­able the CD­MO to pro­vide vi­ral vec­tor man­u­fac­tur­ing in­clud­ing AAV, lentivi­ral, CD­MO, CTO and process de­vel­op­ment faster while re­duc­ing de­vel­op­ment time and costs.

“By in­creas­ing dose yields and dra­mat­i­cal­ly re­duc­ing process de­vel­op­ment time, our Viru­s­Ex­press 293 AAV Pro­duc­tion Plat­form will ac­cel­er­ate man­u­fac­tur­ing of these ther­a­pies, ul­ti­mate­ly de­liv­er­ing life­sav­ing treat­ments to pa­tients faster,” said Dirk Lange, head of life sci­ence ser­vices of Mer­ck KGaA, in a state­ment.

Mil­li­pore­Sig­ma’s pro­duc­tion of AAV and lentivirus through its plat­form will al­low for eas­i­er man­age­ment, ad­just­ment and scale of its as­sets. The process al­so al­lows for larg­er batch yields and more pa­tient dos­es while al­so be­ing less la­bor in­ten­sive.

A re­cent­ly launched Flori­da com­pa­ny is look­ing to scale up a new 60,000-square-foot fa­cil­i­ty.

As­sure In­fu­sions, a man­u­fac­tur­er of IV flu­id prod­ucts, is build­ing a man­u­fac­tur­ing plant in Bar­tow, Flori­da. The fa­cil­i­ty, which is sched­uled to open in 2023, will be ful­ly au­to­mat­ed with ad­vanced ro­bot­ics to make IV flu­ids for the US health­care sys­tem. The com­pa­ny’s flu­id prod­ucts in­clude nor­mal saline, dex­trose, Ringer’s lac­tate and ster­ile wa­ter.

“Hav­ing read­i­ly avail­able IV flu­ids is crit­i­cal for qual­i­ty health­care, but un­for­tu­nate­ly, there is of­ten a short­age of these prod­ucts in the U.S. due to a lack of do­mes­tic man­u­fac­tur­ing, sup­ply chain is­sues and pro­duc­tion lim­i­ta­tions of cur­rent man­u­fac­tur­ers,” said As­sure In­fu­sions CEO Alex Lu­cio in a press re­lease.

The fa­cil­i­ty will al­so cre­ate 100 high-pay­ing jobs with em­ploy­ees work­ing along­side ro­bot­ics.

BioIVT, a New York-based provider of biospec­i­mens, re­search mod­els and di­ag­nos­tic ser­vices, has ac­quired Cypex, a Dundee, UK-based man­u­fac­tur­er of re­com­bi­nant xeno­bi­ot­ic me­tab­o­liz­ing en­zymes.

“The ac­qui­si­tion of Cypex en­hances BioIVT’s prod­uct port­fo­lio, en­sur­ing that we con­tin­ue to meet all our bio­phar­ma­ceu­ti­cal cus­tomers’ re­search re­quire­ments for their en­tire R&D pipeline,” said BioIVT CEO Richard Haigh in a state­ment.

While the terms of the deal were not dis­closed, BioIVT stat­ed that it has ac­quired Cypex’s man­u­fac­tur­ing fa­cil­i­ty in Dundee.

Cypex’s orig­i­nal prod­ucts, which were de­vel­oped by the Uni­ver­si­ty of Dundee, en­able the ex­pres­sion of hu­man drug-me­tab­o­liz­ing en­zymes in bac­te­ria, with­out re­quir­ing large mod­i­fi­ca­tions to the pro­teins.

Since launch­ing in 2000, Cypex has now had more than 115 re­com­bi­nant en­zymes as well as ser­vices for in­hi­bi­tion screen­ing, pro­tein ex­pres­sion and drug metabo­lite gen­er­a­tion.

Re­search com­pa­ny J-Star is mak­ing some moves in the Gar­den State.

The com­pa­ny has kicked off con­struc­tion on a crys­tal­liza­tion and drug prod­uct fa­cil­i­ty in Cran­bury, NJ.

The new $20 mil­lion, 40,000 square-foot build­ing, which is slat­ed to open in Q4 of this year, will be cGMP-ca­pa­ble of the pro­duc­tion of drug prod­uct sup­plies and will ex­pand its abil­i­ty to of­fer in­te­grat­ed drug sub­stance (DS) and drug prod­uct (DP) R&D Ser­vices. Ac­cord­ing to J-Star, the fa­cil­i­ty will op­er­ate un­der the lead­er­ship of Jian Wang, SVP of crys­tal­liza­tion R&D and drug prod­ucts.

The fa­cil­i­ty will in­clude six cGMP suites, ex­pand­ed crys­tal­liza­tion R&D and re­ac­tion en­gi­neer­ing lab­o­ra­to­ries, of­fices and sup­port­ing util­i­ties, and will have around 70 sci­en­tists work­ing there.

The fa­cil­i­ty is al­so lo­cat­ed near J-Star’s fa­cil­i­ty in Cran­bury as well.

As de­vel­op­ment in tar­get­ed ra­di­a­tion ther­a­pies be­comes more preva­lent, a Chi­nese biotech is look­ing to make a deep dive in­to its de­vel­op­ment and man­u­fac­tur­ing.

Ablaze Phar­ma and the Wen­jiang Dis­trict Gov­ern­ment of Cheng­du have signed off on a strate­gic agree­ment for the com­pa­ny to build a $100 mil­lion R&D man­u­fac­tur­ing cen­ter for the cre­ation of tar­get­ed ra­di­a­tion ther­a­pies.

With around 26,000 square me­ters of in­dus­tri­al land set aside in Cheng­du, Chi­na’s med­ical city, the biotech is look­ing to de­vel­op tar­get­ed ra­dio­phar­ma­ceu­ti­cal ther­a­pies, which in­clude five an­ti-tu­mor va­ri­eties which are stuck un­der re­search at present.

Ac­cord­ing to the com­pa­ny, the as­sets un­der re­search vary from Ac-225 to Lu-177.

“We are deeply im­pressed by the strong sup­port and recog­ni­tion of the new­ly emerg­ing tar­get­ed ra­dio­phar­ma­ceu­ti­cal en­ter­pris­es from the Wen­jiang Dis­trict Gov­ern­ment in the city of Cheng­du. Ablaze hopes to work with oth­er com­pa­nies in the park to build an ecosys­tem of tar­get­ed ra­dio­phar­ma­ceu­ti­cals from ear­ly dis­cov­ery to com­mer­cial­iza­tion with the help of the re­source ad­van­tages in nu­clear sci­ence and tech­nolo­gies in Sichuan Province, and to pro­mote the fu­ture de­vel­op­ment and progress of ra­dio­phar­ma­ceu­ti­cal drugs in Chi­na,” said Alex Qiao, Ablaze’s CEO in a state­ment.

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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