Manufacturing roundup: Societal CDMO nets new customers; Chime Biologics gets the OK to manufacture antibodies - Endpoints News

So­ci­etal CD­MO has been award­ed ser­vice con­tracts for three new cus­tomers. The agree­ments in­clude an ar­ray of man­u­fac­tur­ing ser­vices, for clin­i­cal tri­als, an­a­lyt­i­cal meth­ods, for­mu­la­tion de­vel­op­ment and cGMP man­u­fac­tur­ing.

For the first con­tract, So­ci­etal will sup­port the ini­ti­a­tion of a Phase II clin­i­cal study of an an­ti­de­pres­sant al­ready ap­proved for use in Eu­rope and Aus­tralia. So­ci­etal will be re­spon­si­ble for sourc­ing, prepar­ing, pack­ag­ing and la­bel­ing of both the study drug and match­ing place­bo for use in the tri­al. These ac­tiv­i­ties will be con­duct­ed in col­lab­o­ra­tion at its fa­cil­i­ties in Geor­gia and Cal­i­for­nia.

In ad­di­tion, So­ci­etal will help de­vel­op a liq­uid oral for­mu­la­tion, and then pro­duce and pack­age an ini­tial batch, of an in­ves­ti­ga­tion­al treat­ment for pe­di­atric pa­tients with di­etary re­stric­tions who al­so have neu­ro­log­i­cal and neu­ropsy­chi­atric dis­eases.

And in the third con­tract, So­ci­etal will sup­port an­oth­er clin­i­cal tri­al — a Phase II study of an an­ti­sense oligonu­cleotide be­ing test­ed in var­i­ous can­cers. So­ci­etal will la­bel, store and dis­trib­ute the can­di­date as part of the con­tract.

“These new agree­ments spot­light the full range of ser­vices that So­ci­etal CD­MO pro­vides its cus­tomers, start­ing with ef­forts in the ar­eas as an­a­lyt­i­cal method and process de­vel­op­ment, as well as for­mu­la­tion de­sign, and ad­vanc­ing in­to cGMP man­u­fac­tur­ing, pack­ag­ing, la­bel­ing, and dis­tri­b­u­tion. Im­por­tant­ly, two of these new agree­ments in­volve our clin­i­cal tri­al ser­vices busi­ness, which we view as a key dri­ver of growth for the com­pa­ny,” said So­ci­etal CD­MO’s CEO David En­loe in a state­ment.

Chime Bi­o­log­ics re­ceives a Chi­nese man­u­fac­tur­ing li­cense

Chime Bi­o­log­ics, which net­ted in­vestor cash in 2021 for a 15x man­u­fac­tur­ing ex­pan­sion, has re­ceived a com­mer­cial man­u­fac­tur­ing li­cense from the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion (NM­PA) in Chi­na.

Ac­cord­ing to the com­pa­ny, af­ter an 18 month prod­uct de­vel­op­ment and man­u­fac­tur­ing col­lab­o­ra­tion with LEPU Bio­phar­ma, the com­pa­ny passed a pre-ap­proval in­spec­tion, in­clud­ing an on-site in­spec­tion and GMP com­pli­ance in­spec­tion.

Un­der the part­ner­ship with LEPU Bio­phar­ma, Chime will man­u­fac­ture an an­ti-PD-1 mon­o­clon­al an­ti­body dubbed Puy­ouheng, which has been con­di­tion­al­ly ap­proved for mar­ket­ing in Chi­na. The drug is ap­proved for pa­tients with un­re­sectable or metasta­t­ic mi­crosatel­lite in­sta­bil­i­ty-high or mis­match re­pair de­fi­cient (dMMR) ad­vanced sol­id tu­mors.

“This al­so marks the of­fi­cial en­try of Chime Bi­o­log­ics in­to the era of com­mer­cial pro­duc­tion ser­vice. Chime Bi­o­log­ics will work with Lepu side by side to pro­vide al­ter­na­tive med­ical so­lu­tions to can­cer pa­tients in Chi­na and the rest of the world,” said Chime CEO John Zeng in a state­ment.

Te­va hits sup­ply snag for its AD­HD med­ica­tion Adder­all

Te­va has hit a bump with its pop­u­lar AD­HD drug Adder­all.

Ac­cord­ing to the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists (ASHP), both 20mg and 30mg tablets of Adder­all are cur­rent­ly on back­o­rder in the US, as the com­pa­ny is eye­ing a re­lease date lat­er this month. The FDA drug short­age track­er doesn’t note a cur­rent Adder­all short­age. Ac­cord­ing to it, an Adder­all short­age has pre­vi­ous­ly been re­solved, but the site al­so warns that its data­base is ex­pe­ri­enc­ing tech­ni­cal dif­fi­cul­ties and may be out-of-date.

The ASHP said Te­va is ex­pe­ri­enc­ing back­o­rder is­sues with its gener­ic ver­sion of Adder­all as well. How­ev­er, the com­pa­ny is ex­pect­ed to re­lease more 10mg gener­ic tablets in Au­gust, fol­lowed by 15mg and 30mg tablets.

For Adder­all, Te­va is aim­ing to re­lease more 20 mg and 30 mg tablets in ear­ly- to mid-Au­gust, ASHP said.

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