Emily Leproust, Twist

Twist Bio­science plots its 'fac­to­ry of the fu­ture' in Ore­gon, seeks to ex­pand syn­thet­ic DNA client base

One of the lead­ing play­ers at the fore­front of syn­thet­ic DNA pro­duc­tion, Cal­i­for­nia-based Twist Bio­science has al­ready had a busy 2020. Now, seek­ing to ex­pand its client base and tech­nol­o­gy ca­pa­bil­i­ties even fur­ther, it’s build­ing its “fac­to­ry of the fu­ture.”

Twist, which man­u­fac­tures syn­thet­ic DNA by writ­ing it on a sil­i­con chip plat­form, will build a 110,000-square-foot fa­cil­i­ty near Port­land, Ore­gon, that will more than dou­ble its cur­rent pro­duc­tion ca­pac­i­ty by the time the fa­cil­i­ty is op­er­a­tional in 2022.

Emi­ly Lep­roust, Twist co-founder and CEO, said in a state­ment that the fac­to­ry will al­low Twist to serve client pop­u­la­tions in the biotech sphere that it sim­ply can’t with the com­pa­ny’s cur­rent pro­duc­tion ca­pac­i­ty—hence the name “fac­to­ry of the fu­ture.”

“We are ex­pand­ing our cus­tomer base and ramp­ing pro­duc­tion of our prod­ucts at an ex­cep­tion­al rate,” she said. “The (fac­to­ry) al­lows us to sup­port the in­creas­ing needs of our cus­tomers as they scale glob­al­ly and plan for ag­gres­sive growth in­to syn­thet­ic bi­ol­o­gy and bio­phar­ma mar­ket seg­ments we can­not serve to­day.”

The cap­i­tal out­lay as­so­ci­at­ed with the fa­cil­i­ty, lo­cat­ed more specif­i­cal­ly in Wilsonville, was kept un­der wraps. How­ev­er, Twist said it ex­pect­ed the plant to bring some 400 jobs to the area by the time it’s up and run­ning.

Be­yond its “fac­to­ry of the fu­ture,” Twist has had a busy 2020. Most re­cent­ly, the com­pa­ny in Oc­to­ber an­nounced a col­lab­o­ra­tion with Neo­gene to study CAR-T and TCR ther­a­pies for can­cer pa­tients. Twist will cre­ate a TCR li­brary — a self-pro­claimed “li­brary of li­braries” — to aid Neo­gene’s search for en­gi­neered TCRs against tar­gets in can­cer, and Twist will al­so use the li­brary to dis­cov­er an­ti­bod­ies for fu­ture Neo­gene CAR-T can­di­dates.

In Ju­ly, the com­pa­ny tapped Erin Smith to be its se­nior vice pres­i­dent of gov­ern­ment af­fairs and pub­lic pol­i­cy, a new­ly-cre­at­ed po­si­tion. Smith had pre­vi­ous­ly helped lead the ex­pan­sion of a gov­ern­ment af­fairs pro­gram at Gilead.

And in Feb­ru­ary, Twist and Lep­roust spent $22.5 mil­lion to set­tle one of the biggest is­sues hang­ing over the com­pa­ny — a four-year le­gal bat­tle over Lep­roust’s de­par­ture from Ag­i­lent. Ag­i­lent, a 20-year old syn­thet­ic DNA man­u­fac­tur­er, al­leged that Lep­roust mis­ap­pro­pri­at­ed trade se­crets and was in breach of con­tract when she left Ag­i­lent to start Twist with co-founders Bill Banyai and Bill Peck.

In that set­tle­ment, nei­ther Ag­i­lent nor Twist ad­mit­ted any li­a­bil­i­ty or wrong­do­ing.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

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.

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In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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With the ground bro­ken on a Van­cou­ver head­quar­ters, an­ti­body mak­er Ab­Cellera will add man­u­fac­tur­ing space next door

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AbCellera has landed a site in Vancouver for a 130,000-square-foot facility to help bring the biotech’s antibody therapies to clinical trials. In April, the company broke ground on a 380,000-square-foot headquarters that will be within walking distance of the new manufacturing facility, set to be built on a vacant two-acre site.

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In the latest segment of the Emergent BioSolutions saga, US Rep. Carolyn Maloney (D-NY) and Rep. James Clyburn (D-SC) have sent letters to executives with AstraZeneca and J&J expanding the investigation into the mishap at the CDMO’s Baltimore plant that resulted in millions of doses of Covid-19 being wasted.

The two are chairs of the House Committee on Oversight and Reform and asked in a press release what went wrong in the plant and what led to the signing of federal contracts that were reportedly worth up to $1.5 billion.

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J&J, Leg­end un­veil plans for Bel­gian cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty as the part­ners await ap­proval for lead drug

In a race to get BCMA CAR-T candidates to market, J&J and Legend are adding a new EU manufacturing facility in Belgium to the fold as they prepare to file.

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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.