The Gov­ern­ment Ac­count­abil­i­ty Of­fice on Fri­day re­leased a re­port call­ing on the FDA to bet­ter en­cour­age the adop­tion of ad­vanced drug man­u­fac­tur­ing prac­tices, par­tic­u­lar­ly as in­ter­views with 15 stake­hold­ers from in­dus­try said de­lays in adopt­ing ad­vanced tech are re­lat­ed to reg­u­la­to­ry un­cer­tain­ties.

In ad­di­tion to not en­cour­ag­ing more ad­vanced man­u­fac­tur­ing prac­tices, like con­tin­u­ous man­u­fac­tur­ing, GAO found that the FDA “lacks in­for­ma­tion on the ex­tent to which its in­dus­try en­gage­ment and pol­i­cy and guid­ance ef­forts en­cour­age adop­tion of ad­vanced man­u­fac­tur­ing.” What’s more, the FDA has not even de­fined or doc­u­ment­ed its goals in this area, GAO found.

“FDA da­ta show that rel­a­tive­ly few drugs man­u­fac­tured us­ing an ad­vanced man­u­fac­tur­ing tech­nol­o­gy are cur­rent­ly ap­proved for mar­ket­ing,” the new re­port says, not­ing that be­tween 2015 (when CDER first ap­proved a drug that used ad­vanced tech) and last Oc­to­ber (the most re­cent da­ta avail­able), CDER had ap­proved just 16 ap­pli­ca­tions or sup­ple­ments that used ad­vanced man­u­fac­tur­ing tech.

FDA of­fi­cials, mean­while, told GAO that part of the prob­lem is that com­pa­nies’ de­ci­sions to adopt ad­vanced man­u­fac­tur­ing is based on mul­ti­ple fac­tors, and hard to make a busi­ness case for, but most of those are out­side the scope and con­trol of the FDA.

Even still, the agency and for­mer act­ing com­mis­sion­er Janet Wood­cock have made clear that ad­vanced man­u­fac­tur­ing tech is a high pri­or­i­ty and can help shore up the sup­ply chain and drug qual­i­ty con­cerns dur­ing pub­lic health emer­gen­cies like the pan­dem­ic. GAO al­so not­ed that ear­li­er in the pan­dem­ic, the FDA signed off on two Covid-19 drugs that are made us­ing ad­vanced man­u­fac­tur­ing process­es.

Ear­li­er this month, the agency joined with its Eu­ro­pean reg­u­la­to­ry col­leagues in adopt­ing a new qual­i­ty-re­lat­ed ICH guide­line on con­tin­u­ous man­u­fac­tur­ing, known as Q13.

On the oth­er side of the coin, the 15 in­dus­try stake­hold­ers that GAO in­ter­viewed said that most of the rea­son they were slow to adopt new man­u­fac­tur­ing tech was be­cause of the FDA, ex­plain­ing that

reg­u­la­to­ry chal­lenges con­tributed to un­cer­tain­ty about when and whether a drug man­u­fac­tured us­ing ad­vanced man­u­fac­tur­ing will be ap­proved. This un­cer­tain­ty weak­ens the busi­ness case for, and con­tributes to slow adop­tion of, ad­vanced man­u­fac­tur­ing. For ex­am­ple, ac­cord­ing to stake­hold­ers, the un­fa­mil­iar[ity] of FDA ap­pli­ca­tion re­view staff with ad­vanced man­u­fac­tur­ing may lead to de­lays in ap­proval.

The re­port, which GAO con­duct­ed as part of a CARES Act pro­vi­sion re­quest­ing more in­fo on the fed­er­al pan­dem­ic re­sponse, ul­ti­mate­ly con­clud­ed that the FDA needs to make more in­formed de­ci­sions on which of its ini­tia­tives “should be con­tin­ued or ex­pand­ed or whether cor­rec­tive ac­tions are war­rant­ed, thus con­tribut­ing to the larg­er fed­er­al fo­cus on in­creas­ing the use of ad­vanced man­u­fac­tur­ing for drugs.”

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.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.