Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

Ger­man mR­NA play­er BioN­Tech opened the doors to a new man­u­fac­tur­ing fa­cil­i­ty on Thurs­day, this one just about 75 miles north of its head­quar­ters in Mainz, Ger­many.

BioN­Tech an­nounced on Thurs­day that it has com­plet­ed the con­struc­tion of its first plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Mar­burg, Ger­many. The fa­cil­i­ty will pro­duce ma­te­ri­als for mR­NA-based vac­cines and ther­a­pies along with cell ther­a­pies.

Once the fa­cil­i­ty is ful­ly op­er­a­tional and has all the reg­u­la­to­ry checks, BioN­Tech plans to have it in­de­pen­dent­ly make plas­mid DNA for can­di­dates and even­tu­al com­mer­cial prod­ucts. How­ev­er, if there are peaks in de­mand, BioN­Tech stat­ed that it may part­ner with oth­er sup­pli­ers. The com­pa­ny ex­pects the new fa­cil­i­ty to al­low faster plas­mid DNA pro­duc­tion and de­liv­ery times for its can­di­dates and prod­ucts.

“We plan to man­u­fac­ture mR­NA-based prod­ucts for a broad range of clin­i­cal tri­al can­di­dates at our Mar­burg site while we are prepar­ing pro­duc­tion mea­sures for the com­mer­cial man­u­fac­tur­ing of per­son­al­ized on­col­o­gy ther­a­peu­tics,” said CEO Uğur Şahin in a re­lease.

Şahin added in the re­lease that BioN­Tech ac­quired the Mar­burg site back in the fall of 2020 and has been con­sis­tent­ly ex­pand­ing and in­vest­ing in it since. The site has two plants, one ded­i­cat­ed to small-scale man­u­fac­tur­ing to be used in the clin­i­cal space while the oth­er is ded­i­cat­ed to com­mer­cial pro­duc­tion. BioN­Tech cur­rent­ly has 22 prod­ucts in its pipeline with 26 clin­i­cal tri­als run­ning.

The plant for clin­i­cal pro­duc­tion has been run­ning since Au­gust of last year. The com­mer­cial plant is an­tic­i­pat­ed to be op­er­a­tional by the end of the year for a to­tal in­vest­ment of around €40 mil­lion ($43.7 mil­lion). BioN­Tech was not im­me­di­ate­ly avail­able for an in­ter­view.

BioN­Tech has been grad­u­al­ly grow­ing its man­u­fac­tur­ing pres­ence across the world over the past year. Con­struc­tion work has kicked off for an mR­NA man­u­fac­tur­ing fa­cil­i­ty in Ki­gali, Rwan­da. That fa­cil­i­ty will be more mod­u­lar and will man­u­fac­ture mR­NA and mR­NA-based vac­cines for the African mar­ket.

The mR­NA gi­ant al­so ex­pand­ed in­to Sin­ga­pore in 2021, es­tab­lish­ing a home for its south­east Asia re­gion­al head­quar­ters with plans to pro­duce mR­NA vac­cines and ther­a­peu­tics in the fu­ture. That fa­cil­i­ty is slat­ed to come on­line this year.

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.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Sulagna Bhattacharya, Nanoscope Therapeutics CEO

Nanoscope’s eye dis­ease gene ther­a­py shows mixed re­sults in PhII

Dallas-based biotech Nanoscope Therapeutics unveiled Phase II results on its gene therapy for a rare eye disease Thursday morning.

In the RESTORE trial, 18 patients with retinitis pigmentosa got a gene therapy called MCO-010 while nine got placebo. On a vision test called the MLYMT, the treatment group had a one-point greater change over one year in their score compared to the placebo group, the primary endpoint of the study. However, the 95% confidence interval was 0.0 to 3.0, meaning the result was not statistically significant. The p-value was not provided.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

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.