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.

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.

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.

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.

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.

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.

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.