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Jaime Shamonki, Generate CMO

Al­ready sit­ting on a ma­jor stem cell bank, Gen­er­ate looks to grow its re­gen­er­a­tive med­i­cines busi­ness

Generate Life Sciences is the largest private newborn stem cell biorepository, and with the announcement of its own in-house manufacturing facility, the company is looking to grow its regenerative medicine pipeline.

Generate has established a facility in La Jolla, CA, to provide end-to-end manufacturing for newborn stem cell biologics. The site will allow Generate to evolve as it adds a personalized therapeutics developer to its current business model. The new site has been designed to harness mesenchymal stem cells from the tissue of the umbilical cord.

Fabian Gerlinghaus (Cellares)

A cou­ple months af­ter land­ing $100 mil­lion in fund­ing, Cel­lares grabs part­ner for its Cell Shut­tle

The team at Cellares hopes that its Cell Shuttle is the future of end-to-end cell therapy manufacturing. On Wednesday, the company announced that one more company has signed up to work alongside it.

Poseida has signed on to provide therapies for the Cell Shuttle, a portable factory Cellares hopes will disrupt the expensive and logistically complicated cell therapy manufacturing process. The company is the third to ink a deal with Cellares, which is based out of South San Francisco, CA. Cellares has already has been collaborating with PACT Pharma and the Fred Hutchinson Cancer Research Center.

Marc Funk, Recipharm

Mo­roc­can gov­ern­ment drops $500M in­to new Re­ci­pharm fill-fin­ish plant in big boost for African man­u­fac­tur­ing

Recipharm has inked a deal with the Moroccan government to build a new fill-finish factory over the next five years to up vaccine and therapeutic capacity and capability, the company announced Tuesday.

The Moroccan government will invest $500 million in the build, which will be primary dedicated to African vaccine manufacture.

The factory will be operational by 2023, if all goes according to plan, and will mirror the company’s current fill-finish site in Monts, France; except at 107,000 square feet, it will be operating on a much larger scale. Recipharm will not be on the hook for any of the money going into the plant, just its operations, a spokesperson for the company confirmed in an email to Endpoints News on Thursday.

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FDA hands a warn­ing let­ter to a Lupin sub­sidiary af­ter fail­ing to main­tain clean­li­ness once again

From India to NJ, the core of the FDA’s instructions to Lupin subsidiary Novel Laboratories were the same: establish proper cleaning and process validation guidelines at your manufacturing sites. And after failing to do so for the third time in four years, the company has received a warning letter.

Drug residue on tablet presses and a failure to validate the manufacturing process after equipment changes were just two of the issues raised by the FDA after an inspection of a Novel Laboratories plant that led to the June 11 letter.

Evotec ex­pands pres­ence in Italy with ac­qui­si­tion of for­mer Glax­o­SmithK­line R&D site

Germany-based Evotec established its presence in Italy four years ago. Now, it’s bought up more real estate in the neighborhood.

Evotec has acquired an R&D site in Verona from GSK, the company announced Thursday. The company did not disclose financial details of the deal.

GSK used the site for the specialized manufacturing of finished dose form of cephalosporin. It features sterile powder fill to vials, monorails and Add-Vantage vials and flexible packaging lines. It’s approved by the FDA and EMA, as well as and has maintained global regulatory approvals.

Jason O'Neill, Dendreon CEO

Years af­ter bank­rupt­cy, Den­dreon adds a con­tract man­u­fac­tur­ing wing

When CEO Jason O’Neill came aboard Dendreon just a year ago, he saw that the company was in a unique position: It occupied a rare space as one of the few end-to-end providers of cell therapy manufacturing services. And if it were to add a division of contract manufacturing arm to its operations, it would position itself as one of just four US companies that are doing so.

So with that, the Seal Beach, California-based biopharma company has established a contract manufacturing and services division to bring late-stage clinical projects through to the market.

Minzhang Chen, WuXi STA CEO

WuXi will add 500 jobs at Delaware man­u­fac­tur­ing cam­pus as it looks to bol­ster its CD­MO arm

Spurred on by a growing demand for outsourced manufacturing, a slew of CDMO firms have uncorked big expansion plans to keep up. Now, Chinese drugmaker WuXi AppTec is planting its flag in Delaware as part of an ambitious plan to expand its CDMO arm’s work stateside.

WuXi STA has picked New Castle County, DE, as the home for its newest CDMO site, planning to build on 190 acres and add up to 50 local jobs by 2026, the Chinese company said this week.

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Catal­ent bags a Ger­man stem cell de­vel­op­er to build its next-gen ther­a­peu­tics wing

Another day, another acquisition for CDMO giant Catalent. The New Jersey firm has now bought out Germany’s RheinCell Therapeutics, a specialist in human induced pluripotent stem cells, to build out its next-gen therapies wing.

The German company is based in Langenfeld, outside of Düsseldorf, around 2.5 hours’ drive from Catalent’s campus for cell and gene therapy in Gosselies, Belgium, allowing for efficient transfer. After the deal closes, which is expected before the end of 2021, RheinCell’s employees will join Catalent’s cell and gene therapy operations. The acquisition helps Catalent build upon its current cell therapy development and manufacturing capabilities.

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Javier García Cogorro, Viralgen CEO

A vi­ral vec­tor play­er is ex­pand­ing its foot­print in Basque Coun­try amid height­ened de­mand

As the demand for viral vectors grows unabated amid the Covid-19 pandemic, a CDMO is dropping a serious investment to build out a new Basque Country facility.

The new facility is in the same technology park as Viralgen’s existing manufacturing site. It increases capacity five-fold, and clients should expect the first batches from its 2,000-liter bioreactor released by the middle of next year. The $83.1 million investment will turn into a $142.4 million tab after the final two buildings are completed. The expansion will bring 130 new jobs to Viralgen, which should grow the team to 250 people by 2022.

Fu­ji­film out­lays whop­ping $850M for its Diosynth CM­DO wing, look­ing to rapid­ly scale cell cul­ture pro­duc­tion

Fujifilm Diosynth Biotechnologies is on a spending spree and not stopping yet.

The Japanese firm is adding manufacturing capability at its core CDMO wing by pumping $850 million into locations in the US and UK, it said in a release.

Gene therapy capacity in the UK will increase 10-fold, cell culture capacity will be tripled and microbial fermentation output will be doubled at the 5,000-liter facility. In the US, cell culture production for recombinant vaccines will double. These two expansions will start in 2023.