Bi­o­log­ics man­u­fac­tur­ing is an ex­pen­sive and com­pli­cat­ed process — but that hasn’t stopped some of the bio­phar­ma in­dus­try’s biggest play­ers from mak­ing big splash­es in re­cent years. Now, a Seat­tle-based CD­MO is drop­ping a ma­jor down pay­ment to dou­ble its pres­ence in the field.

Cit­ing an in­creased de­mand from glob­al part­ners, Seat­tle-based AGC Bi­o­log­ics will pour $194 mil­lion in­to flesh­ing out its bi­o­log­ics man­u­fac­tur­ing at its Copen­hagen site, the com­pa­ny said late last month. The rough­ly 204,000-square-foot ex­pan­sion in a new build­ing will al­low the glob­al CD­MO to dou­ble its ca­pac­i­ty for work with sin­gle-use biore­ac­tor mam­malian cell-cul­tures.

Patri­cio Massera

AGC Bi­o­log­ics will ex­pand the Copen­hagen site on ad­ja­cent land through the ad­di­tion of pro­duc­tion floors with 2,000-liter sin­gle-use biore­ac­tors, labs and of­fice spaces. The ex­pan­sion is ex­pect­ed to go on­line in 2023 as the com­pa­ny “con­tin­u­ous­ly look(s) for ways to ex­pand and ex­tend our ca­pa­bil­i­ties and ca­pac­i­ties for our cur­rent and fu­ture cus­tomers,” CEO Patri­cio Massera said in a news re­lease.

In re­cent months, AGC has con­tin­ued to roll out an am­bi­tious growth plan — in­clud­ing a fa­cil­i­ty in Boul­der, CO — and has tak­en an ac­tive role in the pro­duc­tion of a COVID-19 vac­cine. From the Copen­hagen fa­cil­i­ty, AGC Bi­o­log­ics will man­u­fac­ture Ma­trix-M, the ad­ju­vant com­po­nent of No­vavax’s coro­n­avirus vac­cine, NVX-CoV2373.

Al­so through its part­ner­ship with No­vavax, the com­pa­ny is work­ing at its Seat­tle fa­cil­i­ty to ex­pand Ma­trix-M sup­ply to en­sure vac­cine stock for the U.S.

AGC Bi­o­log­ics is far from the on­ly com­pa­ny seek­ing to ex­pand its im­pact. In mid-No­vem­ber, Ko­re­an biosim­i­lar gi­ant Cell­tri­on un­veiled plans to stick $453 mil­lion in­to build­ing a new re­search cen­ter and man­u­fac­tur­ing fa­cil­i­ty in In­cheon, Ko­rea. The news came less than a year af­ter the com­pa­ny green­lit a $514 mil­lion bi­o­log­ics plant in Chi­na.

Sam­sung Bi­o­log­ics al­so an­nounced this year that it would break ground on a $2 bil­lion, 2.5 mil­lion-square-foot “Su­per Plant” in In­cheon. CEO Tae Han Kim said in Sep­tem­ber that the plant — the com­pa­ny’s fourth — is an in­vest­ment in “a to­tal line re­fine­ment and ad­di­tion of new mid- and small-scale fa­cil­i­ties to en­sure pro­duc­tion ef­fi­cien­cy and pro­vide top-notch ser­vices to raise the bar even fur­ther to es­tab­lish our­selves as the lead­ing glob­al stan­dard.”

Sam­sung ex­pects man­u­fac­tur­ing there to be­gin in the lat­ter half of 2022.

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

French CDMO Yposkesi will build its second commercial cell and gene therapy facility in Corbeil-Essonnes, near Paris, the company announced last week.

The project is dubbed SKY, and will also develop a global resource for drug developers of ATMPs. It will cost about $71 million, and encompass 50,000 square feet upon completion. The Project will create 80 new jobs, and address a shortage in manufacturing capacity for companies looking to advance clinical trials and commercialize therapeutics, the press release said. The site will have two additional production lines and several 1,000-liter bioreactors.

Unauthorized versions of the Covid-19 drug remdesivir bound for distribution in Mexico were seized by US federal authorities, The Wall Street Journal reported.

The drug, which is manufactured by Gilead, has been counterfeited and is arriving in the US on planes from Bangladesh and India for patients willing to pay exorbitant asking prices. US Customs and Border Protection has captured more than 100 shipments, sources told the Journal.

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.