Abzena picks North Car­oli­na as the home for its 6th man­u­fac­tur­ing site, plans to add 325 jobs in San­ford

While Boston and San Fran­cis­co are the un­ques­tioned lead­ing biotech hubs in the US, drug­mak­ers — par­tic­u­lar­ly con­tract man­u­fac­tur­ers — are look­ing else­where for cheap­er re­al es­tate and un­tapped po­ten­tial. Now, a San Diego-based bi­o­log­ics mak­er look­ing to rapid­ly scale up is set­ting down roots in North Car­oli­na.

CD­MO Abzena will add 325 jobs in San­ford, NC, as part of a $200 mil­lion bi­o­log­ics plant that will even­tu­al­ly house around 24,000 square feet of biore­ac­tor ca­pac­i­ty, the com­pa­ny said.

The fa­cil­i­ty is com­ing as part of a mul­ti-phase out­lay that will add four mod­u­lar suites in the ini­tial phase, each of which will house two 2,000-liter biore­ac­tors. A sec­ond phase will add an­oth­er two suites with the 2,000-liter biore­ac­tors, for a to­tal of 12. The fa­cil­i­ty, Abzena said, will ac­com­mo­date Phase III and com­mer­cial man­u­fac­tur­ing, and will al­so be equipped to han­dle con­tin­u­ous man­u­fac­tur­ing and per­fu­sion by the mid­dle of 2022.

Kim­ball Hall

The ex­pan­sion al­so comes as a big boon for North Car­oli­na, one of the fastest-grow­ing biotech hubs in the coun­try.

“North Car­oli­na of­fers great re­sources for ac­cess to a tal­ent­ed work­force and oth­er re­sources for us as we bring the new fa­cil­i­ty on-line,” Abzena Pres­i­dent and COO Kim­ball Hall said in a state­ment.

The Abzena an­nounce­ment comes just weeks af­ter CD­MO Fu­ji­film Diosynth Biotech­nolo­gies al­so picked North Car­oli­na as the fu­ture home of its own $2 bil­lion bi­o­log­ics site that will ri­val some of the largest fa­cil­i­ties in the world. The Japan­ese sub­sidiary picked Hol­ly Springs, NC, for its cell cul­ture, plan­ning to add 725 jobs in the area by 2028.

Fu­ji­film had been search­ing for a home for the plant af­ter an­nounc­ing its in­tent to build back in Jan­u­ary. The com­pa­ny eyed lo­ca­tions with­in shout­ing dis­tance of its ex­ist­ing US sites in Col­lege Sta­tion, TX, and Mor­risville, NC. Ul­ti­mate­ly, North Car­oli­na won the lot­tery due to its “strong pool of tech­ni­cal tal­ent, lo­cal re­sources and part­ners with the right com­pe­ten­cies, clean en­er­gy re­sources, and sus­tain­abil­i­ty for fu­ture growth,” Fu­ji­film said in a re­lease.

The plants will come on­line in spring 2025 and house eight 20,000-liter biore­ac­tors with the po­ten­tial to ex­pand and add a fur­ther 24 biore­ac­tors of the same size “based on mar­ket de­mand,” the com­pa­ny says. The site will al­so in­clude com­mer­cial-scale, au­to­mat­ed fill-fin­ish and as­sem­bly, pack­ag­ing and la­bel­ing ser­vices.

So­cial im­age: Jonathan Gold­man, Abzena CEO

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Al­ta­sciences, true to its word, ex­pands its foot­print with ac­qui­si­tion of Penn­syl­va­nia CRO

A Canadian CDMO with roots in Seattle is coming to the east coast.

Altasciences announced the acquisition of Calvert Laboratories Wednesday, a preclinical CRO in Pennsylvania. The move will complement Altasciences’ Seattle-area operations.

Headquartered in Laval, Canada, Altasciences operates six facilities that run the gamut on early drug development: preclinical safety testing, clinical pharmacology, bioanalytical, CRO services, and even CDMO capacity. Novo Holdings scooped them up in February with the goal of courting small and medium-sized biopharma clients. CEO Chris Perkin said back in February that the move would help the company foster its ambitious growth plan, and this acquisition and the presence it brings to the east coast is evidence.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House Democrats in Washington and members of the European Parliament have now glommed onto a major push by India and South Africa at the WTO to abolish all IP around Covid-19 vaccines.

At first blush, waiving this IP sounds like an easy win: More Covid-19 vaccines made locally for more people means more lives saved. Simple enough, especially as low-income countries have received just a tiny fraction of the world’s vaccine allotment so far.