Costs ris­ing, As­traZeneca switch­es con­trac­tors and once again de­lays sched­uled com­ple­tion of its trou­bled $650M-plus HQ project

De­sign of As­traZeneca’s Cam­bridge Bio­med­ical Cam­pus

Click on the im­age to see the full-sized ver­sion

Those ru­mors about big trou­ble for As­traZeneca’s $650 mil­lion (plus) HQ project proved to be en­tire­ly ac­cu­rate. To­day a spokesper­son for the phar­ma gi­ant tells me that they are switch­ing build­ing con­trac­tors and once again sig­nif­i­cant­ly de­lay­ing a planned move-in at the Cam­bridge, UK site. And the price tag for com­ple­tion is head­ed high­er.

Their state­ment in re­sponse to a query:

Yes, as the sci­en­tif­ic fit-out and com­mis­sion­ing phase of the build­ing takes shape, we are tran­si­tion­ing from Skan­s­ka to a com­pa­ny called Mace which has ex­per­tise in this next phase. As we be­gin this sci­en­tif­ic fit-out we will have more up­dates but, as of now, we’re look­ing at oc­cu­pa­tion in first half of 2020.

The pun­ish­ing set­back came af­ter a UK trade pub cit­ed Skan­s­ka’s trou­ble in get­ting the sprawl­ing head­quar­ters site com­plete — a full 5 years af­ter it was be­gun. The project — in­tend­ed to rep­re­sent As­traZeneca’s bold em­brace of new tech and its com­mit­ment to the UK’s bio­phar­ma hub — has be­come an ex­pen­sive al­ba­tross around CEO Pas­cal So­ri­ot’s neck as he push­es to turn around the com­pa­ny.

Orig­i­nal­ly the project was to be com­plet­ed in 2016, then 2017 and most re­cent­ly in the spring of 2019 as As­traZeneca in­tend­ed a stag­gered oc­cu­pa­tion for the lo­cal R&D work force, which has swelled in an­tic­i­pa­tion of the rib­bon-cut­ting cer­e­mo­ny. This new set of con­struc­tion goals will push the move-in to a full 7 years af­ter con­struc­tion was green-light­ed at As­traZeneca.

As the work slowed, it al­so be­came sig­nif­i­cant­ly more ex­pen­sive. Orig­i­nal­ly slat­ed to cost about $430 mil­lion, the com­pa­ny had to add $220 mil­lion more. Now it’s head­ed even high­er.

As­traZeneca de­clined to say what the new price tag on the build­ing is, but con­ced­ed that the es­ti­mate has now pushed past the $650 mil­lion mark.

(W)hat we can say is that our over­all in­vest­ment in our Cam­bridge HQ project will be high­er than ini­tial­ly com­mu­ni­cat­ed, now at over £500m. The in­creased in­vest­ment re­flects our com­mit­ment to Cam­bridge and the UK sci­ence-base, in par­tic­u­lar:

  • We have ac­cel­er­at­ed our tran­si­tion to the Cam­bridge area ahead of build­ing com­ple­tion and over 2,600 of our staff are al­ready here.
  • Part of our in­vest­ment in the new site is more state of the art equip­ment and tech­nolo­gies and we are in­vest­ing heav­i­ly in this space.

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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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