The biopharma world's manufacturing weekly

Endpoints Manufacturing

Manufacturing channel feed

Mer­ck to boost Gar­dasil pro­duc­tion; In­creased de­mand for Sanofi’s RSV drug; Take­da ad­dress­es fa­cil­i­ty ‘im­pair­ment’ 

Last year

Heard at #CPHI: VC fund­ing trends; Sam­sung eyes ex­pan­sion; and sup­ply chain di­ver­si­fi­ca­tion

Last year

WuXi TIDES boosts oli­go, pep­tide of­fer­ings due to a rise in de­mand, with new builds on­go­ing

Last year

Eu­ro­pean Com­mis­sion out­lines how coun­tries can share drugs to mit­i­gate short­ages

Last year
FDA+

Eu­roAPI CEO steps down; Sam­sung Bi­o­log­ics looks to Eu­rope; Mer­ck re­calls pneu­mo­coc­cal vac­cines

Last year

Ther­mo Fish­er grows in­to CGT man­u­fac­tur­ing, while Sam­sung Bi­o­log­ics ex­pands in­to AD­Cs

Last year
Cell/Gene Tx

Re­mote FDA drug in­spec­tions: New draft guid­ance spells out post-pan­dem­ic specifics

Last year
FDA+

Up­dat­ed: Form 483 for UCB's Swiss site notes de­fi­cien­cies in qual­i­ty con­trol op­er­a­tions

Last year

BioN­Tech CAR-T man­u­fac­tur­ing change leads to fresh da­ta with vac­cine com­bo, with reg­is­tra­tional tri­al plans: #ES­MO23

Last year
R&D
Cell/Gene Tx

Nec­tar Life­sciences hit with un­ti­tled let­ter over re­peat GMP is­sues at an­timi­cro­bial site

Last year
FDA+

Sam­sung's bi­o­log­ics plant in South Ko­rea re­ceives Form 483 over da­ta in­tegri­ty, oth­er ob­ser­va­tions

Last year
FDA+

Bio­con slammed with OAI; Hong Kong looks to WuXi for ADC abil­i­ties; Tan­vex Phar­ma launch­es CD­MO ser­vices 

Last year

Lon­za’s mod­est fore­cast for cell and gene ther­a­pies points to un­cer­tain­ty about sec­tor's fu­ture

Last year

Up­dat­ed: J&J builds out glob­al man­u­fac­tur­ing ca­pac­i­ty for CAR-T Carvyk­ti

Last year
Cell/Gene Tx

Mayo Clin­ic-backed Nu­cle­us Ra­dio­Phar­ma rais­es $56M in Se­ries A to boost CD­MO ser­vices

Last year
Financing

Lon­za braces for 2024 prof­it im­pact due to Mod­er­na, Ko­di­ak man­u­fac­tur­ing cuts

Last year

Lon­za un­veils two sep­a­rate vac­cine, ADC man­u­fac­tur­ing deals that could lead to 415 new Swiss jobs

Last year
Deals

Synaf­fix joins forces with So­tio on $740M ADC li­cens­ing deal, plans ex­pan­sion af­ter Lon­za ac­qui­si­tion

Last year

Re­ci­pharm CEO an­tic­i­pates 2024 will be ‘as hard’ for CD­MOs, strat­e­gy will be key for en­durance

Last year

Fu­ji­film Irvine work­force cuts; Gates Foun­da­tion in­vests in Africa-made vac­cines; Sharp ac­quires BSM

Last year

Alvotech’s Reyk­javik man­u­fac­tur­ing dol­drums con­tin­ue with CRL for Ste­lara biosim­i­lar

Last year
FDA+

FDA hits New Jer­sey API man­u­fac­tur­er with 14 de­fi­cien­cies across three sites in Form 483

Last year
Pharma
FDA+

Eu­roAPI stock craters af­ter slow CD­MO, API busi­ness slash­es 2023 sales fore­cast

Last year

Bay­er takes next step in cell ther­a­py, open­ing new $250M fa­cil­i­ty in Berke­ley

Last year
Cell/Gene Tx
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