Emer­gent BioSo­lu­tions is fac­ing a fresh set of man­u­fac­tur­ing trou­bles as the FDA is­sued a warn­ing to the com­pa­ny re­gard­ing its Bal­ti­more site.

Emer­gent re­vealed in an SEC fil­ing on Fri­day that the US reg­u­la­tor is­sued a warn­ing let­ter on Aug. 10, flag­ging two ar­eas of con­cern at the com­pa­ny’s Cam­den man­u­fac­tur­ing fa­cil­i­ty in Bal­ti­more.

The FDA let­ter point­ed to de­fi­cien­cies in the Emer­gent plant’s sys­tems for clean­ing and main­te­nance of equip­ment to pre­vent con­t­a­m­i­na­tion of drug prod­ucts, specif­i­cal­ly re­lat­ed to par­tic­u­lates from the met­al trays. It al­so not­ed de­fi­cien­cies in process­es and prac­tices sur­round­ing asep­tic pro­cess­ing.

The warn­ing let­ter from the FDA said that most of the tray units at the fa­cil­i­ty have suf­fered ap­par­ent dam­age and were al­so in­ad­e­quate for use in ster­ile drug pro­duc­tion. Emer­gent al­so lacked any specifics re­gard­ing its doc­u­ment ac­tiv­i­ties for the in­spec­tion, iden­ti­fi­ca­tion, seg­re­ga­tion, eval­u­a­tion, re­pair or re­tire­ment of de­fec­tive tray units.

While Emer­gent stat­ed to the FDA that it im­prove­ments to the pro­gram mon­i­tor­ing asep­tic pro­cess­ing per­son­nel be­hav­ior and class­room train­ing on asep­tic be­hav­iors the US reg­u­la­tor found that that re­sponse was not ad­e­quate.

The FDA rec­om­mend­ed to Emer­gent that it should re­view and as­sess its qual­i­ty man­age­ment sys­tem and en­gage a con­sul­tant to go over the com­pa­ny’s CGMP op­er­a­tions. In the SEC fil­ing, Emer­gent said it re­tained a third par­ty to con­duct an ad­di­tion­al re­view of the fa­cil­i­ty and to pro­vide over­sight of on­go­ing process­es at the Cam­den site.

“Bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing is com­plex, and the stakes are high. That is why we have made sig­nif­i­cant in­vest­ments to up­grade our phys­i­cal ca­pa­bil­i­ties and are fo­cused on strength­en­ing our cul­ture of qual­i­ty and com­pli­ance. This is a process that doesn’t hap­pen overnight, but one to which we are com­mit­ted,” ac­cord­ing to a state­ment from Emer­gent.

Emer­gent did not re­spond to any fur­ther in­quiries from End­points News.

How­ev­er, this is not the first time the Mary­land-based man­u­fac­tur­er has crossed paths with the FDA. In April 2021, Emer­gent had to shut down pro­duc­tion at its Bayview fa­cil­i­ty and quar­an­tine any ex­ist­ing ma­te­ri­als in the wake of a John­son & John­son vac­cine man­u­fac­tur­ing fi­as­co. At the time, FDA in­ves­ti­ga­tors found the com­pa­ny’s qual­i­ty unit failed to en­sure ba­sic func­tions of its op­er­a­tions, in­clud­ing elec­tron­ic da­ta that were ma­nip­u­lat­ed and delet­ed, and qual­i­ty unit pro­ce­dures that had not been put in­to writ­ing, among an ar­ray of oth­er is­sues.

And it’s not the on­ly prob­lem that Emer­gent is deal­ing with. Last month, Emer­gent claimed that J&J that it will have to pay some­where in the range of $125 mil­lion to $420 mil­lion if J&J ter­mi­nates its Covid man­u­fac­tur­ing con­tract as the Big Phar­ma winds down its Covid-19 vac­cine op­er­a­tions be­fore ful­fill­ing the min­i­mum re­quire­ments in its con­tract with Emer­gent.

Ad­di­tion­al Emer­gent man­u­fac­tur­ing is­sues around the J&J vac­cine al­so are be­ing re­vealed in new con­gres­sion­al com­mit­tee find­ings re­leased last Thurs­day. It showed that 135 mil­lion more coro­n­avirus vac­cine dos­es man­u­fac­tured at Emer­gent’s Bal­ti­more-based fa­cil­i­ty for J&J were des­ig­nat­ed for de­struc­tion due to qual­i­ty de­fi­cien­cies. That brings the to­tal num­ber of dos­es wast­ed to north of 525 mil­lion.

Emer­gent has 15 days from Aug. 10 to re­spond to the FDA and they are en­cour­aged to cor­rect any vi­o­la­tions prompt­ly. Fail­ure to ad­dress the mat­ter may re­sult in reg­u­la­to­ry or le­gal ac­tion or the with­hold­ing of ex­port cer­tifi­cates, among oth­er ac­tions.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.