Ginkgo Bioworks, Inc.

Welcome to Endpoints News ’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Pfizer is laying off employees across its manufacturing facilities in Ireland, including at Grange Castle, Ringaskiddy and Newbridge. The workforce cuts will start in the last quarter of this year and will continue into next year, the company confirmed to Endpoints News in an email. No further details were given. Baxter Pharmaceuticals has closed it North Cove facility in Marion, NC, due to Hurricane Helene causing “excessive” rain and flooding damage. The company is working to get the site back up and running, and its utilizing the rest of its manufacturing network to try and mitigate any potential supply issues. While the full impact of the site closure has yet to be seen, this will have a “negative” impact on the company’s annual revenue, Baxter said in a release on Sunday. Recipharm announced on Thursday it’s expanding its clinical and commercial pharmaceutical development and manufacturing offerings. The CDMO is expanding its small molecule site in Bengaluru, India, by adding a lab for developing sterile products. The company has also added a manufacturing line at its Wasserburg, Germany, site and has expanded its site in Kaysersberg, France. No financial details were disclosed. Recipharm also partnered with US-based CDMO Exela Pharma Sciences this week, to expand sterile manufacturing offerings in the US, the company said on Tuesday. The new partnership will give Recipharm access to Exela’s factory in Lenoir, NC, which houses abilities in manufacturing sterile injectables in vials and pre-filled syringes. India-based CDMO Piramal Pharma Solutions is investing $80 million to expand its sterile injectable facility in Lexington, KY, the company said on Monday. The expansion will add 24,000 square feet of capacity, including a new laboratory and manufacturing space. The expansion is anticipated to be finished in the first quarter of 2027. Bill and Melinda Gates Foundation-backed TerraPower Isotopes is now commercially producing the radioisotope Actinium-225 , the company announced on Tuesday. California-based SK pharmteco is injecting $260 million to build a new small molecule and peptide manufacturing facility in Sejong, South Korea, the company said on Sunday. The 135,800 square-foot facility will house R&D facilities as well as clinical and commercial manufacturing capabilities. Operations are anticipated to start in late 2026. Radioisotope producer Nusano has raised over $115 million in a Series C funding round, the company said on Tuesday. The raise will be used to help the company launch new products, including non-carrier-added lutetium-177 and actinium-225. BioCryst Pharmaceuticals has been awarded a $69 million contract from the US Department of Health and Human Services, according to a Monday announcement. Under the new contract, BioCryst will supply up to 95,625 doses of its flu vaccine, Rapivab, to the US government’s national stockpile over five years. Cell therapy CDMO Excellos has been chosen by Galapagos to make its CAR-T cell therapy asset, dubbed GLPG5101, for a Phase 1/2 clinical trial in patients with relapsed or refractory non-Hodgkin lymphoma. Excellos will make the candidate at its site in San Diego, CA, according to the Tuesday press release. Ferring Pharmaceuticals has opened a new 25,000 square-meter manufacturing site in Kuopio, Finland, which will make drug substances for its gene therapy Adstiladrin, a treatment for patients with non-muscle invasive bladder cancer, the company said on Thursday. Ginkgo Bioworks and Virica Biotech are partnering to reduce the cost of manufacturing gene therapies, the companies said on Thursday. Both companies are providing and integrating their gene therapy manufacturing platforms to offer a combined service to customers.

A UK-based synthetic biology startup has brought in $58 million from private investors to fund its work engineering cell systems that can manufacture new and existing molecules. The company, called Constructive Bio, has its roots in the lab of Jason Chin, a leading scientist at the Medical Research Council Laboratory of Molecular Biology (LMB) in Cambridge. Chin, who also serves as the company’s founder and chief scientist, published a study in 2019 showing his lab synthesized the entire E. coli genome with a more compact genetic code. Constructive’s Series A was led by Ahren, OMX Ventures and Paladin Capital Group, and also included investments from Fine Structure Ventures, +ND Capital and Jonathan Milner, the founder of research tools supplier Abcam. Nobel laureate Sir Gregory Winter, known for his work on antibody drugs, will join Constructive Bio’s board as a representative of Ahren. The company plans to use the funds to continue to work on several programs, including one making incretin mimetics — a drug class that includes the blockbuster obesity medicines Wegovy and Zepbound from Novo Nordisk and Eli Lilly. “We’ve shown that we can, at Constructive, make semaglutide analogs and incretin mimetics,” Chin said. “Two things that we’ll use this fundraise for [are] to further explore the incretin mimetics that we can make using our technology, and to look at the scalable production of incretin mimetics, because there’s a lot of challenges about the ways they’re currently made — using lots of solvents. There’s a real inability to meet the projected global supply.” Chin also highlighted how Constructive’s platform could potentially help build better antibody-drug conjugates, where they can tweak the stability, half-life, and targeting abilities of proteins that are manufactured. Constructive previously announced a $15 million seed raise in 2022, and has raised a total of $75 million to date. Chin said the company is “pretty much commercially ready — we can make things at commercial titers. We can introduce a wide range of building blocks. We’ve done a lot in the seed phase. We’ve done a lot of the optimization from the academic lab into the company that we felt we needed to do.” The UK company’s raise comes as other, once high-flying synthetic biology companies have faced significant challenges. Ginkgo Bioworks announced earlier this year that it was cutting spending and laying off staff. “The underlying proposition that biology can ultimately deliver the ability to do things that really can’t be done by any other means, that it can do things in a way that is greener and more sustainable, is ultimately correct,” Chin said. “But there will be in any sector — there’ll be a range of different opportunities.”

Plus, news about Longevity Biomedical, Sensorion, Teva and Bristol Myers Squibb: Context Therapeutics buys a T cell engager: The biotech will pay $15 million upfront and up to $118.5 million in biobucks for BioAtla’s Nectin-4 x CD3 T cell engager for solid tumors. Companies developing T cell engagers, or TCEs, have received more interest in recent months , particularly as they have started to test out the therapies in autoimmune diseases . — Kyle LaHucik Ginkgo Bioworks creators are back with another SPAC: The executives behind the blank check company that took Ginkgo Bioworks public have returned with plans for a new $250 million SPAC called Bold Eagle Acquisition. Ginkgo $DNA was valued at about $15 billion when it went public in September 2021. It’s now valued at $445 million. Bold Eagle’s leaders are serial SPAC creators and have been involved in several blank check combinations outside of biopharma including with Lionsgate Studios, Skillz, DraftKings and Target Hospitality. — Kyle LaHucik Longevity Biomedical also inks SPAC deal: The therapeutics and digital health company plans to combine with FutureTech II Acquisition and trade on the Nasdaq as $LBIO . Longevity’s pipeline includes a device for ischemic stroke, tissue biomaterial for soft-tissue reconstruction and other programs. — Kyle LaHucik Sensorion touts data from hearing loss pipeline: The French biotech said the first child given its gene therapy, SENS-501, in a Phase 1/2 trial tolerated the treatment well and had no adverse events. Meanwhile, data from a Phase 2 test of its small molecule drug, SENS-401, after seven weeks of treatment showed that 40% of patients had complete hearing preservation. — Ayisha Sharma Teva unveils Phase 3 schizophrenia results: The Tel Aviv-based company’s long-acting injectable, olanzapine, achieved “significant improvements” in the primary endpoint of the Positive and Negative Syndrome Scale (PANSS) total score at eight weeks. Teva is testing a subcutaneous form of its intramuscular injection. The safety profile was also consistent with oral formulations of olanzapine. — Ayisha Sharma Bristol Myers Squibb to lay off 79 workers in New Jersey: According to a Worker Adjustment and Retraining Notification notice , BMS plans to let go 79 employees in Lawrenceville, NJ, between December and January. BMS did not respond to a request for comment. The drugmaker has conducted several rounds of layoffs this year, including previous layoffs in Lawrenceville and letting go of 252 employees from a Mirati Therapeutics site in San Diego in March. — Katherine Lewin