Seat­tle's AGC plots $194M in­vest­ment to dou­ble pro­duc­tion at Copen­hagen site in busy year for bi­o­log­ics

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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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