Northway Biotech's new manufacturing facility in Greater Boston

North­way Biotech sets up shop in Boston hub, look­ing to court more cus­tomers with bi­o­log­ics-fo­cused plant

Get­ting a foot in the door in Boston’s bustling bio­phar­ma hub is a rite of pas­sage for many com­pa­nies, but it comes with a steep price tag. Lithuan­ian CD­MO North­way — now with a new moniker — will set up a new plant in close prox­im­i­ty, and it’s hop­ing its bi­o­log­ics fo­cus will find a will­ing cus­tomer base.

North­way Biotech (for­mer­ly North­way Biotech­phar­ma) on Wednes­day held a vir­tu­al grand open­ing cer­e­mo­ny for its $40 mil­lion Waltham, MA fa­cil­i­ty — a 30,000 square-foot cGMP man­u­fac­tur­ing and process de­vel­op­ment plant that will wide­ly ex­pand on the com­pa­ny’s pre­vi­ous ca­pa­bil­i­ties.

Cit­ing a de­sire to get its feet in­to the Boston-area hub, North­way set up its new plant to fo­cus on cell-line de­vel­op­ment, drug sub­stance man­u­fac­tur­ing, asep­tic fill­ing and end-to-end ser­vices for both mi­cro­bial and mam­malian bi­o­log­ics.

Ex­pect­ed to be ful­ly op­er­a­tional by the fi­nal quar­ter of 2021, North­way said in a press re­lease that the fa­cil­i­ty al­ready has ful­ly es­tab­lished labs for process, an­a­lyt­i­cal method de­vel­op­ment and qual­i­ty con­trol that have been sup­port­ing client projects for the past six months or so. Once ful­ly op­er­a­tional, the site will host 500-liter mi­cro­bial and 2,000-liter mam­malian biore­ac­tors.

It was an im­por­tant “strate­gic mile­stone” for the com­pa­ny, which has been in op­er­a­tion since 2004 in Lithua­nia and in Lon­don, North­way CEO Vladas Al­gir­das Bumelis said in a state­ment.

“We are very ex­cit­ed about this ex­pan­sion and are poised to sup­port our next-door part­ners in the Boston biotech hub, as well as oth­er do­mes­ti­cal­ly or in­ter­na­tion­al­ly lo­cat­ed com­pa­nies, by en­abling ac­cel­er­at­ed de­vel­op­ment and man­u­fac­tur­ing of their nov­el, life-sav­ing bio­phar­ma­ceu­ti­cals for clin­i­cal or com­mer­cial needs,” he said.

North­way’s Waltham site marks the lat­est biotech for­ay in­to Boston’s rapid­ly grow­ing biotech hub, which is burst­ing at the seams as it ex­pands in­to neigh­bor­ing cities. In ear­ly 2020, for ex­am­ple, End­points News re­port­ed that on­ly 0.8% of lab space was va­cant and still avail­able for rent in the area, while near­by East Cam­bridge (home to Kendall Square) was en­tire­ly oc­cu­pied — even with the high rent av­er­age of near $110 per square foot.

Just this week, Bio­Med Re­al­ty an­nounced a deal for near­ly 1.3 mil­lion square feet worth of space in Somerville, just five miles from Boston, and is seek­ing out ten­ants for what will be­come a ma­jor site in one of the world’s pre­mier biotech spaces.

Al­so of note re­cent­ly in the Boston area, Bris­tol My­ers Squibb in Au­gust inked a deal for a 360,000 square-foot lease at Cam­bridge Cross­ing, part of a 43-acre life sci­ences hub be­ing built on the city line be­tween Cam­bridge and Somerville.

As for North­way, the com­pa­ny has al­so wad­ed in­to the Covid-19 ther­a­peu­tics are­na of late. The com­pa­ny in Au­gust part­nered with Memo Ther­a­peu­tics, a Swiss biotech, to man­u­fac­ture Memo’s an­ti­body can­di­date over a four-month fast-track process. The drug can­di­date, gen­er­at­ed from con­va­les­cent Covid-19 donors, fo­cused on pi­co­mo­lar neu­tral­iz­ing ac­tiv­i­ty, the com­pa­nies said in an ini­tial press re­lease.

In De­cem­ber, soon af­ter the ini­tial fast-track process con­clud­ed, Memo an­nounced that the can­di­date was 100% ef­fec­tive in pre­vent­ing and treat­ing Covid-19 in ham­sters, and that the drug was head­ed to­ward a first-in-hu­man tri­al in the first quar­ter of this year.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Avid Bioser­vices, with re­cent IPO and Covid-19 part­ner­ship in hand, launch­es 2nd phase of fa­cil­i­ty ex­pan­sion

California’s Avid Bioservices now has two simultaneous expansion projects underway as the CDMO’s projections for customer demand sparked the launch this week of the second phase of building out its Myford facility.

Avid expects construction on the second phase, which will be known as its Myford South facility to take 18 to 24 months to complete at a cost of roughly $45 million to $55 million, it said in a press release.

Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden wants a re­view of the API sup­ply chain. Will that par­lay in­to an ef­fort to 'on­shore' drug man­u­fac­tur­ing?

When former President Donald J. Trump was voted out of office Nov. 2, his gung-ho effort to “onshore” drug manufacturing was left mostly up in the air. Joe Biden has been mostly mum on whether he would continue that effort, but a new executive order could provide a clue — at least in a few months.

In an order signed Wednesday, Biden demanded a 100-day governmental review of key supply chains, including for active pharmaceutical ingredients (API) used in American drugs.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Dutch biotech In­travacc seeks to bol­ster Nether­lands vac­cine man­u­fac­tur­ing abil­i­ties with new plants

The pandemic has given a huge edge to any country that can produce vaccine in its borders. Now one vaccine biotech is looking to make sure their country has that edge for any future pandemic.

Arguing Covid-19 exposed the Netherlands’ “vulnerability,” Dutch vaccines company Intravacc recently announced that its new “modern pilot production plant” will soon be functional and that it’s spearheading a conglomerate designing a multipurpose vaccine production plant.