As the US em­barks on a bil­lion-dol­lar ini­tia­tive to on­shore ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) man­u­fac­tur­ing, the Eu­ro­pean Union re­leased a re­port ear­li­er this month weigh­ing the pros and cons of any pos­si­ble reshoring of API pro­duc­tion.

The 58-page re­port notes that over the past decade, med­i­cine short­ages have been in­creas­ing through­out Eu­rope, as they have across the pond, with con­cerns raised that out­sourc­ing API man­u­fac­tur­ing abroad may have con­tributed to dis­rup­tions in the sup­ply chain. A pro­pos­al to reshore API man­u­fac­tur­ing to EU mem­ber states has been pro­posed, but it’s un­clear if it will gain trac­tion.

The new re­port, which was re­quest­ed by the Eu­ro­pean Par­lia­ment’s Com­mit­tee on En­vi­ron­ment, Pub­lic Health and Food Safe­ty, found that sev­er­al pol­i­cy doc­u­ments have ad­dressed API man­u­fac­tur­ing as a po­ten­tial so­lu­tion to try and pre­vent, or at least mit­i­gate, med­i­cine short­ages on the con­ti­nent. Those doc­u­ments ex­plain how reshoring API pro­duc­tion is chal­leng­ing and has high costs and work­force needs, along with reg­u­la­to­ry changes at­tached.

How­ev­er, the re­port states that any in­crease of API pro­duc­tion in Eu­rope should be a ben­e­fi­cial en­deav­or, which could serve to strength­en con­ti­nen­tal sup­ply chains, pos­si­bly re­duc­ing dis­rup­tions and im­prov­ing qual­i­ty.

The re­port said:

While the sup­ply chains in the phar­ma­ceu­ti­cal sec­tor are high­ly glob­alised, Eu­rope still has some API pro­duc­tion, main­ly those of low pro­duc­tion vol­umes, com­plex pro­duc­tion process­es, and the Eu­ro­pean API sec­tor is con­sid­ered high­ly com­pet­i­tive, giv­en its tech­ni­cal know-how and strong work­force ca­pac­i­ties.

The re­port de­tailed that in 2019, near­ly 36% of API man­u­fac­tur­ing sites were in Eu­rope, while 55% were in Asia, pri­mar­i­ly Chi­na and In­dia. The EU’s gener­ic API pro­duc­tion was found to rep­re­sent 24% of the to­tal, while 66% went to In­dia and Chi­na.

“Re­lo­cat­ing man­u­fac­tur­ing op­er­a­tions back to Eu­rope is a grow­ing trend in near­ly every in­dus­try sec­tor, in­clud­ing the phar­ma­ceu­ti­cal sec­tor. Sev­er­al phar­ma­ceu­ti­cal man­u­fac­tur­ers in Eu­rope have an­nounced plans for new in-coun­try API de­vel­op­ment and man­u­fac­tur­ing ca­pa­bil­i­ties,” the re­port said.

It al­so looked at three ex­am­ples of Eu­ro­pean API man­u­fac­tur­ing, main­ly in France and Aus­tria, that have gov­ern­ment fund­ing go­ing to com­pa­nies from EU mem­ber states to boost API pro­duc­tion.

Ul­ti­mate­ly, the re­port found that hav­ing a lo­cal source of APIs is ben­e­fi­cial in terms of en­sur­ing bet­ter qual­i­ty, bet­ter de­liv­ery times, and over­com­ing cer­tain chal­lenges.

When it comes to high­er op­er­at­ing costs, the re­port states that:

Cen­tral and East­ern Eu­ro­pean coun­tries (e.g., Czech Re­pub­lic, Poland, Hun­gary) may like­ly be po­ten­tial can­di­dates for new pro­duc­tion lo­ca­tions in Eu­rope giv­en their low­er staff costs. In prac­tice, how­ev­er, high­er-in­come coun­tries, such as Ger­many, the Nether­lands and Bel­gium have al­so been men­tioned as at­trac­tive pro­duc­tion lo­ca­tions. It has been ar­gued that new tech­nolo­gies will lead to an in­crease in au­toma­tion and ro­bo­t­i­sa­tion, and as a re­sult staff cost may play a low­er role.

But, while the EU al­so has cur­rent ini­tia­tives in play to reshore API man­u­fac­tur­ing, which are usu­al­ly backed by fi­nan­cial sup­port from na­tion­al gov­ern­ments, it is not clear whether these can se­cure API pro­duc­tion in the long run, the re­port laid out.

The re­port rec­om­mends that if gov­ern­ments are look­ing to bring API man­u­fac­tur­ing back to the con­ti­nent, it should con­sid­er what APIs are crit­i­cal for pa­tients and if so, gov­ern­ments should con­sid­er the “eco­nom­ic pa­ra­me­ters” or the fea­si­bil­i­ty of the process. Al­so, the sup­ply of APIs and med­i­cine pro­duc­tion should be en­sured, and the fo­cus of reshoring should not pri­mar­i­ly be on APIs to pre­vent short­ages.

Ini­tia­tives to sup­port lo­cal man­u­fac­tur­ing of APIs should al­so not ex­clu­sive­ly fo­cus on fi­nan­cial in­vec­tives but al­so reg­u­la­to­ry and ad­min­is­tra­tive process­es as well.

“It should be con­sid­ered that fur­ther coun­tries (main­ly Chi­na, In­dia and the USA) are al­so un­der­tak­ing ef­forts to strength­en or in­ten­si­fy lo­cal pro­duc­tion. These ef­forts might re­sult in in­creased com­pe­ti­tion be­tween coun­tries,” the re­port notes.

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.