FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has hand­ed Tor­rent Phar­ma­ceu­ti­cals an of­fi­cial ac­tion in­di­cat­ed (OAI) sta­tus for a pre­vi­ous­ly in­spect­ed man­u­fac­tur­ing fa­cil­i­ty in In­dia.

Tor­rent Phar­ma sent a let­ter to the Na­tion­al Stock Ex­change of In­dia ear­li­er this week with word that the man­u­fac­tur­er has re­ceived a “com­mu­ni­ca­tion from the FDA de­ter­min­ing the in­spec­tion clas­si­fi­ca­tion as ‘Of­fi­cial Ac­tion In­di­cat­ed’ (OAI)” for one of its sites. An OAI clas­si­fi­ca­tion from the FDA comes af­ter the agency has com­plet­ed an in­spec­tion and de­ter­mines if the fa­cil­i­ty com­plies with the ap­plic­a­ble laws and reg­u­la­tions. Be­ing giv­en an OAI clas­si­fi­ca­tion means that reg­u­la­to­ry or ad­min­is­tra­tive ac­tions will be rec­om­mend­ed to Tor­rent. How­ev­er, the de­tails on the rec­om­mend­ed ac­tions have not been giv­en.

“This in­spec­tion clas­si­fi­ca­tion will not have im­pact on ex­ist­ing sup­plies or rev­enues from this fa­cil­i­ty. Tor­rent Phar­ma con­tin­ues to co­op­er­ate with the USF­DA and will un­der­take all nec­es­sary re­me­di­al steps to re­solve these is­sues to the sat­is­fac­tion of the reg­u­la­tor. Tor­rent Phar­ma re­mains com­mit­ted to be­ing cGMP com­pli­ant qual­i­ty stan­dards across all its fa­cil­i­ties,” Tor­rent’s let­ter said.

The new let­ter stems from an FDA in­spec­tion in Sep­tem­ber that record­ed three ob­ser­va­tions at Tor­rent’s man­u­fac­tur­ing site in the vil­lage of In­drad, in the state of Gu­jarat in the na­tion’s east. Ac­cord­ing to the com­pa­ny, the site man­u­fac­tures tablets, cap­sules and vials.

The FDA’s 15-page 483 fil­ing re­vealed that man­u­fac­tur­ing equip­ment in sev­er­al ar­eas had residue from pre­vi­ous ma­te­ri­als that should have been re­moved. The in­spec­tors al­so not­ed meth­ods to mon­i­tor clean­ing were not up to par, a tank that had been marked “cleaned” was “en­crust­ed with a fine white to off-white col­or pow­er residue and flakes in prod­uct con­tact ar­eas,” and dents and changes to the shape of equip­ment were al­so not­ed.

End­points News reached out to Tor­rent for com­ment on the OAI but did not re­ceive a re­sponse by press time.

The Tor­rent fa­cil­i­ty is not the on­ly man­u­fac­tur­ing site in the coun­try to come un­der the FDA’s mi­cro­scope. The FDA hand­ed down an OAI to a Sun Phar­ma man­u­fac­tur­ing fa­cil­i­ty in Halol, In­dia, in 2020, ac­cord­ing to a re­port from the In­di­an news site Busi­ness Stan­dard, with the Halol fa­cil­i­ty re­cent­ly giv­en an im­port alert from US reg­u­la­tors as well.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”