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.

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.

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.

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.

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.

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 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.