A Chi­nese CD­MO has man­aged to put to­geth­er a siz­able Se­ries B.

Por­ton Ad­vanced So­lu­tions has com­plet­ed the fi­nanc­ing round gar­ner­ing over $80 mil­lion.

The com­pa­ny will use the funds to con­tin­ue its busi­ness ex­pan­sion in­to dif­fer­ent mar­kets, with in­vest­ment in man­u­fac­tur­ing in­fra­struc­ture and glob­al com­mer­cial op­er­a­tions.

The CD­MO, which is fo­cused sole­ly on gene and cell ther­a­py ser­vices, has es­tab­lished a CD­MO plat­form pro­vid­ing a wide ar­ray of ser­vices cov­er­ing plas­mids, cell ther­a­py, gene ther­a­py, on­colyt­ic virus, nu­cle­ic acid ther­a­py and mi­cro­bial vec­tors used for gene ther­a­py. The com­pa­ny’s cur­rent op­er­a­tional foot­print in­cludes a 40,000-square-foot site, with an­oth­er 160,000-square-foot fa­cil­i­ty com­ing on­line at the end of the year.

“In the com­ing months, we will con­tin­ue to im­prove and op­ti­mize our in­ter­nal qual­i­ty and pro­gram man­age­ment sys­tems, en­hance our abil­i­ty to op­er­ate in over­seas and do­mes­tic mar­kets, and con­tin­ue to pro­vide the best pos­si­ble CD­MO ser­vices to our cus­tomers with our open, in­no­v­a­tive and re­li­able plat­forms, so that best med­i­cine would reach the pub­lic soon­er,” said Por­ton’s CEO Wang Yangzhou.

The fund­ing round was led by the Chi­na Mer­chants Groups’ health­care PE fund Mer­chant Health, along with its sis­ter fund Chi­na Mer­chants Cap­i­tal, Chi­na Mer­chants Se­cu­ri­ties In­vest­ments. Fo­s­un Health Cap­i­tal, Gor­tune In­vest­ment and SDIC­TK, Por­ton Phar­ma So­lu­tions, CS Cap­i­tal, HM Cap­i­tal, Ruil­ian In­vest­ment and Mo­men­tum Ven­ture, al­so par­tic­i­pat­ed in the round.

Man­u­fac­tur­ing gi­ant Lon­za has ex­pand­ed the range of par­ti­cle en­gi­neer­ing ser­vices of­fered at its Mon­teg­gio, Switzer­land site.

The com­pa­ny will in­tro­duce X-ray pow­der dif­frac­tion (XR­PD), a rapid an­a­lyt­i­cal tech­nique that pro­vides ad­di­tion­al in­for­ma­tion about the poly­morph and sol­id-state prop­er­ties of APIs.’

Ac­cord­ing to the com­pa­ny, mi­croniza­tion via jet milling is a well-es­tab­lished tech­nique to con­trol the par­ti­cle size of APIs and en­hance their pro­cess­ing, bioavail­abil­i­ty, and dis­so­lu­tion rates. How­ev­er, while mi­croniza­tion is an en­er­getic process and yields very fine par­ti­cles, it can al­so re­sult in amor­phous gen­er­a­tion and/or poly­mor­phic changes, which can com­pro­mise the qual­i­ty and sta­bil­i­ty of the prod­ucts.

The ad­di­tion of XR­PD will add to Lon­za’s an­a­lyt­i­cal tool­box and al­low for the gen­er­a­tion of da­ta across drug dis­cov­ery, de­vel­op­ment and man­u­fac­tur­ing. The XR­PD in­stru­ment be­gan op­er­a­tions in Q2 of this year.

“The im­ple­men­ta­tion of XR­PD pro­vides ad­di­tion­al an­a­lyt­i­cal in­for­ma­tion, high­light­ing dif­fer­ences in the sol­id state of ma­te­ri­als be­fore and af­ter mi­croniza­tion, and de­ter­min­ing whether ad­di­tion­al pro­cess­ing is need­ed. The XR­PD im­proves our abil­i­ty to de­tect sol­id state changes in­duced by the mi­croniza­tion process ear­ly in de­vel­op­ment and al­lows the prob­lem to be prop­er­ly ad­dressed be­fore the process is de­fined,” said Sal­va­tore Mer­curi, the as­so­ciate di­rec­tor for new prod­uct in­tro­duc­tion and MSAT at Lon­za Mon­teg­gio, in a state­ment.

ABEC, a provider of en­gi­neered so­lu­tions and ser­vices for biotech man­u­fac­tur­ing, an­nounced on Wednes­day that it will in­vest $11 mil­lion to ex­pand its sin­gle-use dis­pos­able con­tain­er (DC) man­u­fac­tur­ing ca­pac­i­ty for its CSR bio­man­u­fac­tur­ing.

The project is in the city of Wil­son, NC be­tween Raleigh and Greenville, NC. The site in­cludes a 50,000-square-foot fa­cil­i­ty on 13 acres, which will be out­fit­ted with an ISO-7 clean­room and oth­er man­u­fac­tur­ing equip­ment. The new fa­cil­i­ty will be ABEC’s third glob­al DC man­u­fac­tur­ing site and is ex­pect­ed to be ful­ly op­er­a­tional by Q2 of next year.

“We are pleased that the in­dus­try is rec­og­niz­ing the val­ue of our CSR prod­ucts and we are ex­cit­ed about our in­vest­ment in Wil­son,” said Scott Pick­er­ing, ABEC CEO in a state­ment.

The com­pa­ny cur­rent­ly sup­plies DCs glob­al­ly from ISO-7 clean­rooms in Fer­moy, Ire­land, and its HQ in Beth­le­hem, PA. ABEC al­so plans to cre­ate 251 jobs in Wil­son Coun­ty for en­gi­neers and man­u­fac­tur­ing per­son­nel.

LTS Lohmann Ther­a­pie-Sys­teme AG has closed on the ac­qui­si­tion of St. Paul, MN-based CD­MO Tape­mark Inc.

Tape­mark, a CD­MO spe­cial­iz­ing in trans­der­mal drug de­liv­ery sys­tems, oral thin films and unit dose se­mi-sol­id drug and ion­tophore­sis prod­ucts has now joined LTS, a phar­ma­ceu­ti­cal tech­nol­o­gy com­pa­ny that de­vel­ops and man­u­fac­tures drug de­liv­ery sys­tems.

The deal will see Tape­mark’s St. Paul fa­cil­i­ty be­com­ing a part of the world­wide op­er­a­tions net­work of LTS, along with LTS’ ex­ist­ing fa­cil­i­ties in An­der­nach, Ger­many and West Cald­well, NJ.

“This strate­gic ac­qui­si­tion demon­strates our com­mit­ment to con­tin­ue to set the stan­dard as the best CD­MO in TTS and OTF and to strength­en our foot­print in the US, the world’s most im­por­tant phar­ma mar­ket. We will of­fer an even more com­plete port­fo­lio of drug de­liv­ery ex­per­tise and ex­pand­ed man­u­fac­tur­ing ca­pa­bil­i­ties to our cus­tomers and their pa­tients, and we are ex­cit­ed to wel­come Tape­mark’s cus­tomers to LTS’ glob­al net­work. The ac­qui­si­tion strength­ens our R&D ca­pa­bil­i­ties in North Amer­i­ca, al­low­ing us to bring even more in­no­va­tion and de­vel­op­ment sup­port to play­ers de­vel­op­ing in­no­v­a­tive ther­a­pies and new drug de­liv­ery sys­tems,” said LTS CEO Bas van Bui­jte­nen in a state­ment.

The fi­nan­cial terms of the deal, how­ev­er, were not dis­closed to End­points News.

Austin, Tx-based Dis­per­Sol Tech­nolo­gies, LLC, has made some stark changes.

The com­pa­ny has ap­point­ed Tim Scott as the pres­i­dent and CEO of the com­pa­ny as the com­pa­ny is chang­ing its name to Austin­Px Phar­ma­ceu­tics and Man­u­fac­tur­ing. Ac­cord­ing to the com­pa­ny, this move is meant to bet­ter re­flect the com­pa­ny’s new di­rec­tion as a CD­MO.

The com­pa­ny, which has col­lab­o­rat­ed with big names in the past such as Catal­ent, is look­ing to shift its di­rec­tion and will now pro­vide phar­ma­ceu­ti­cal chem­istry ser­vices in­clud­ing an­a­lyt­i­cal and for­mu­la­tion de­vel­op­ment and cGMP man­u­fac­tur­ing at its site in Austin.

Scott him­self was the co-founder and pres­i­dent of Phar­matek Lab­o­ra­to­ries from 1999 un­til 2016 when he sold the com­pa­ny to Catal­ent.

“Our goal is to build a client-cen­tric or­ga­ni­za­tion that pro­vides drug de­vel­op­ment and man­u­fac­tur­ing ser­vices for phar­ma com­pa­nies world­wide,” Scott said in a state­ment.

In 2021, 50 novel medications were approved by the Federal Drug Administration (FDA), the third-highest number of approvals on record and one of many indicators of the extraordinary advancements the medical field has seen in recent decades. But progress within the industry is not equally distributed. When acknowledging the contributions of more than 38,000 patients in its Drug Trials Snapshot of the same year, the FDA noted that “there were many programs where representation from certain racial and ethnic groups was low.” This carefully worded observation describes a long-standing limitation in the clinical trial sector.

Novartis CEO Vas Narasimhan has finally figured out how he can get Sandoz off his list of major headaches. He’s going to spin the generics giant out as a separate company.

The pharma giant says it will set up Sandoz as an independent company in H2 2023 after navigating the separation through regulators. The spinout will create a lumbering giant with a home on the SIX Swiss Exchange, an American Depositary Receipt program in the US, a pipeline of 15 biosimilars and a rep for mediocre performance.

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Following its announcement in March that it would begin enforcing its Covid-19 vaccine patents in wealthy countries, Moderna says it is suing Pfizer and BioNTech over their mRNA shot.

Moderna alleges that Pfizer and BioNTech’s Covid-19 vaccine copied parts of its vaccine technology that it had patented between 2010 and 2016, when it was developing an mRNA vaccine for MERS. Moderna filed its lawsuit in a US district court in Massachusetts and the Regional Court of Düsseldorf in Germany, it said in a press release.

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The FDA’s postmarket regulations require that drug manufacturers notify the agency about any significant product quality defects in marketed products within three working days.

The reports, known as Field Alert Reports (FARs), are crucial for the agency to root out manufacturing issues that can cause recalls or lead to harm.

But a new report from the agency found that of the 1,143 manufacturing sites that were eligible to submit a FAR  from 2018 to 2021, almost half (49%) of the sites did not submit a report.

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A couple months after Bristol Myers Squibb brought its patent fight with Gilead’s Kite unit to the Supreme Court, Gilead is now making the argument that the petition should be denied because it challenges more than 50 years of precedent.

Juno – which was acquired by Celgene and then Bristol Myers Squibb — sued Gilead’s Kite unit back in 2017, alleging that the company’s CAR-T therapy Yescarta infringed on patents that were licensed to Juno by Memorial Sloan Kettering Cancer Center.

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Two recent approvals for two expensive gene therapies for blood disorders — BioMarin’s $1.5 million Roctavian in the EU for hemophilia A and bluebird bio’s $2.8 million Zynteglo in the US for transfusion-dependent thalassemia — is shining a spotlight on outcomes-based pricing deals as both companies look to leverage the strong efficacy and durability of their therapies.

In the case of BioMarin’s Roctavian, execs said in an investor call this week that its outcomes-based agreements with EU member states will differ market by market but provide refunds when someone doesn’t respond to therapy. As only 6 of 134 patients resumed standard of care in the late-stage trial, Jeff Ajer, EVP and chief commercial officer of BioMarin said in an investor call that they’re “very enthusiastic” about such high responder rates.

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Novartis’ first-ever patient DTC ad for metastatic breast cancer drug Kisqali points up the broader and more recent proliferation of mBC treatment options in general.

The 15-second TV commercial features mBC patient and Kisqali user Lauren, who is a wife and mother of three girls, and talks about being the “first generation” of people who will change what it means to live with metastatic breast cancer.

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The Public Company Accounting Oversight Board (PCAOB) has struck an agreement with Chinese regulatory authorities that would allow the inspection of audit reports for US-listed Chinese companies. Now, according to SEC chair Gary Gensler, “The proof will be in the pudding.”

Roughly 200 Chinese companies — including biopharma companies BeiGene, Hutchmed, Zai Lab, I-Mab, Sinovac, Gracell Biotechnologies, Adagene and Burning Rock Biotech — have been singled out by the SEC for violating a new law governing US-listed companies. The law, called the Holding Foreign Companies Accountable Act, stipulates that any foreign companies audited by a firm that the nonprofit PCAOB is unable to review for three consecutive years should be delisted.

A California federal appeals court on Thursday let AbbVie off the hook from a whistleblower lawsuit alleging the company held fraudulent patents on two Alzheimer’s drugs, therefore overcharging Medicare.

The case traces back to a complaint filed by patent lawyer Zachary Silbersher back in 2018, accusing Allergan of withholding information from the Patent Trademark Office that may have led the agency to reject patents for Namenda XR and Namzaric, extended release drugs to treat Alzheimer’s-associated dementia. AbbVie swallowed Allergan for $63 billion in 2020.

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

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