Seattle Children’s collaboration to dive into cell therapy manufacturing; After success in court, Teva found guilty in NY

A cell and gene ther­a­py com­pa­ny is ex­tend­ing its col­lab­o­ra­tion with Seat­tle Chil­dren’s Hos­pi­tal to es­tab­lish man­u­fac­tur­ing prac­tices for cell ther­a­py, the com­pa­ny an­nounced Tues­day.

Bi­o­Life’s new lentivi­ral vec­tor man­u­fac­tur­ing site, dubbed Vec­tor­Works, will be used to find best prac­tices in bio­p­reser­va­tion and closed-sys­tem man­u­fac­tur­ing with the in­tro­duc­tion and in­te­gra­tion of Sex­ton’s AF-500. Seat­tle Chil­dren’s, and its sub­sidiary Seat­tle Chil­dren’s Ther­a­peu­tics, have used Bi­o­Life’s CryoStar for freez­ing me­dia for sev­er­al years in clin­i­cal ap­pli­ca­tions and tri­als to im­prove the post-thaw vi­a­bil­i­ty and re­cov­ery of cells.

‘This ex­pand­ed col­lab­o­ra­tion is an ex­cit­ing step for Seat­tle Chil­dren’s Ther­a­peu­tics as we work to­wards de­vel­op­ing closed-sys­tem process­es for cell ther­a­py man­u­fac­tur­ing,’ said Matt Sel­l­ey, di­rec­tor of GMP man­u­fac­tur­ing for Seat­tle Chil­dren’s. ‘Lentivi­ral vec­tor man­u­fac­tur­ing is a crit­i­cal com­po­nent of the cell pro­duc­tion process.’

The col­lab­o­ra­tion will com­bine AF-500 with Seat­tle Chil­dren’s man­u­fac­tur­ing ex­per­tise. AF-500 can fill and seal up to 560 vials in 90 min­utes, the com­pa­ny says. The CellSeal Con­nect, which builds up­on the tech­nol­o­gy used for the orig­i­nal CellSeal cryo­genic stor­age vials, al­lows for a closed-sys­tem re­trieval of vi­ral vec­tors.

Af­ter big wins in court, Te­va found guilty in NY

Drug man­u­fac­tur­er Te­va Phar­ma­ceu­ti­cals was found guilty by a New York ju­ry for cre­at­ing a pub­lic nui­sance by man­u­fac­tur­ing opi­oid pills that have killed thou­sands of peo­ple across the state, and what the CDC es­ti­mates are more than 600,000 peo­ple across the coun­try.

The man­u­fac­tur­er re­leased a press re­lease stat­ing that it ‘strong­ly dis­agrees’ with the out­come, and is prepar­ing an ap­peal, as well as pur­su­ing a mis­tri­al.

‘In NY, the plain­tiffs pre­sent­ed no ev­i­dence of med­ical­ly un­nec­es­sary pre­scrip­tions, sus­pi­cious or di­vert­ed or­ders, no ev­i­dence of over­sup­ply by the de­fen­dants – or any in­di­ca­tion of what vol­umes were ap­pro­pri­ate – and no causal re­la­tion­ship be­tween Te­va’s con­duct in­clud­ing its mar­ket­ing and any harm to the pub­lic in the state,’ the state­ment said.

In No­vem­ber, Te­va was found not guilty in Cal­i­for­nia by Or­ange Coun­ty, Los An­ge­les Coun­ty, the City of Oak­land, and San­ta Clara Coun­ty on grounds that it caused a pub­lic nui­sance. A su­pe­ri­or court judge in Cal­i­for­nia ruled that opi­oid man­u­fac­tur­ers were not re­spon­si­ble for the cri­sis be­cause of their mis­lead­ing mar­ket­ing. The mu­nic­i­pal­i­ties sought $50 bil­lion in dam­ages from J&J, Ab­b­Vie, En­do and Te­va.

Mean­while in Ok­la­homa, the state’s Supreme Court over­turned an ear­ly rul­ing, stat­ing that the pub­lic nui­sance law in Ok­la­homa doesn’t ex­tend to man­u­fac­tur­ing, mar­ket­ing and sell­ing pre­scrip­tion opi­oids.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

Their Staying Power Lies in their Patient-Centricity

Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.

As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies like Pfizer, Thermo Fisher, Viatris and industry groups are pushing back on new guidance that seeks to establish how that data should be collected and submitted to the agency.

The technical conformance guide, released last October, spells out the requirements under Section 3112(e) of the CARES Act, which was signed into law in March 2020 and added a new section to the FD&C Act.

Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)

It’s big days for biology.

The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.

But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.

Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.

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Chris Perkin, Altasciences via Youtube

Altasciences CEO Chris Perkin has gone through several acquisitions in his 45-year career. And if there’s one thing he learned, it’s how not to go through an acquisition.

His company put that knowledge to use on Tuesday when it announced that it had acquired competitor Sinclair research, a preclinical contract research organization in Missouri. With the pickup, Altasciences gains 80 animal rooms, and full-service IND and NDA-enabling toxicology and safety pharmacology services.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Bursting at the seams and executing plans for swift expansion to support its manufacturing work for the mRNA vaccine out of Pfizer/BioNTech, Indianapolis-based Exelead has now been scooped up in a $780 million cash buyout deal.

Germany’s Merck KGaA, which bought out another mRNA manufacturer, AmpTec, early last year, has been beefing up its ops around lipids, which, in mRNA vaccines, play a key role in turning human cells into a mini—vaccine factories?

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Salvatore Mascia, Continuus Pharmaceuticals CEO

A spinout from an MIT lab has landed a deal with a Swedish development group to build a $125 million manufacturing facility in Woburn, MA, just 15 miles outside Boston.

Skanska signed a contract with Continuus Pharmaceuticals to renovate and build another 50,000 square foot site up to current Good Manufacturing Practices standards that will produce dry active pharmaceutical ingredients and finished drug products in both sterile injectable and tablets forms.

Jay Bradner, NIBR president (Jeff Rumans)

Alnylam was a few years ahead in the small interfering RNA (siRNA) space when Novartis jumped on the bandwagon in early 2020, licensing the company’s cholesterol-lowering drug Leqvio through its buyout of The Medicines Company. Less than a month after securing an approval, the pharma giant wants more where that came from.

Novartis is joining forces with Alnylam once again for the discovery and development of a regenerative siRNA-based therapy to treat end-stage liver disease, the companies announced on Thursday.

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Sosei Heptares is teaming up with a big-name partner: Alphabet’s Verily.

No financials were disclosed, but the pair will aim to use Verily’s immune profiling and Sosei Heptares’ GPCR drug design capabilities to develop a variety of new therapeutics. The collaboration will focus on GPCR drugs in the immunology, gastroenterology and immuno-oncology spaces, as well as other disorders with immunoprotective or immunopathogenic mechanisms, the companies said.

After showcasing clinical data at #ASH21 for a sickle cell disease candidate, Sanofi has decided to throw in the towel on its 8-year partnership with collaborator Sangamo — and return its rights to the candidate.

The gene editing biotech announced the ‘transition’ this morning, several days after Sanofi told Sangamo that the biotech was backing out of the deal. The Paris-based pharma giant will be returning its rights and obligations on SAR445136, a zinc finger nuclease gene-edited cell therapy back to Sangamo by the end of June.
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