Exela Pharma Sciences LLC

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.

Exela Pharma Sciences, based in Lenoir, North Carolina, is a specialty pharmaceutical company focused on developing and manufacturing generic and name-brand sterile injectable products with “high barriers to market entry." Rogue particles turning up in drugs has caused a plethora of recalls in recent years, most recently affecting pharma giants Pfizer and GSK. Now, North Carolina-based specialty drugmaker Exela Pharma Sciences has taken the contamination hit. Exela is working with the FDA to recall three separate medications—injectable sodium bicarbonate for metabolic acidosis; midazolam sodium chloride injection for sedation; and the nutrition additive Elcys, also known as cysteine hydrochloride—after inspections of leftover samples flagged silicone matter in some vials. Exela, based in Lenoir, North Carolina, is a specialty pharmaceutical company focused on developing and manufacturing generic and name-brand sterile injectable products with “high barriers to market entry,” according to the company’s website.   Injecting drugs contaminated with particulates can cause injection site irritation or swelling, Exela warned in an FDA notice. If the particulate matter reaches the blood vessels, it could travel to various organs and block blood vessels in the heart, lungs or brain, the company added. That could cause stroke or even death. As of Wednesday, Exela had not received any side effect flags linked to the recall. Exela is recalling eight batches of sodium bicarbonate that contain 50-ml single-dose vials, according to the FDA recall notice. The drugs were set to expire between November 2023 and December 2024. The recall also covers a single lot of Civica-branded sodium bicarbonate injection that was meant to be good until August of next year. As for the other two drugs in the recall, Exela is pulling just a single lot each of midazolam and Elcys, which were set to expire in July 2024 and March 2025, respectively. Exela shipped out the medications between late July and early August. Bits of matter cropping up in drug batches is a surefire way to trigger a recall, and even pharma juggernauts aren’t immune. At the beginning of October, Pfizer’s Hospira unit issued a voluntary recall of sodium bicarbonate and lidocaine HCI injectables due to the possible presence of glass particles in the vials. Meanwhile, Taiwan’s Food and Drug Administration in July initiated a recall of two batches of GSK’s severe asthma injection Nucala after glass particles were found in a vial of the drug.

GSK initiated the recall, in consultation with Taiwan Food and Drug Administration, as a "precautionary measure," a spokesperson said. In the world of drug packaging, a vial is a vial, the product the product, and never the twain shall meet. When those standards start to slip, recalls are sure to follow. Now, GSK has become the latest drugmaker to learn that lesson. This week, Taiwan’s Food and Drug Administration initiated a recall of two batches of GSK’s severe asthma injection Nucala after glass particles were found in a vial of the drug. The regulator said the recall is expected to wrap up by August 7, local outlet Focus Taiwan reported Tuesday. GSK confirmed the recall to Fierce Pharma. In an emailed statement, a GSK spokesperson said that none of the product reported in the complaint was administered to patients. “GSK—in consultation with Taiwan Food and Drug Administration (TFDA)—has taken the decision to voluntarily recall two batches (#MX9M and #S34T) of NUCALA FD 100MG in Taiwan as a precautionary measure,” the company added. GSK learned of the issue after receiving a complaint from a hospital in Taiwan about the presence of glass particles in one reconstituted vial of the drug. The suspect vial flagged in the alert came from a batch with the lot number MX9M. Concerns about other bottles of Nucala made on the same production line have prompted a recall of a second lot, dubbed S34T. Both batches were produced from a “related semi-finished batch,” according to the company, which noted that no other markets are affected by the recall. All told, the pull covers 2,591 bottles of the respiratory medication, around 1,500 of which have already been sold in Taiwan, the deputy director of the country’s FDA told Focus Taiwan. On average, the country uses about 4,690 bottles of Nucala per year, with no readily available alternative, he added. In turn, GSK Taiwan has reportedly said it’s working to allocate a new shipment of 1,512 bottles from abroad. Nucala is a blockbuster member of GSK’s immuno-inflammation and respiratory business, where the drug brought home sales of £1,423 million (about $1.86 billion) for all of 2022. Often in competition with AstraZeneca’s rival asthma star Fasenra, Nucala first crossed the 1-billion-pound threshold in 2021. The med has picked up a clutch of additional indications since its original approval in 2015 for severe asthma, including nods for granulomatosis with polyangiitis, hypereosinophilic syndrome and rhinosinusitis with nasal polyps. Meanwhile, glass-fueled recalls aren’t exactly unique to GSK. In October, Exela Pharma Sciences yanked 49 lots of an injectable used to treat kidney disease complications over safety concerns of “vial breakage and flying glass.” In addition, Gilead last March suffered an FDA rejection on its application for the long-acting HIV med lenacapavir over concerns that incompatibility between the drug and the vials could creative “subvisible” glass particles. Gilead ultimately refiled its U.S. application with an alternative vial type and snared approval for lenacapavir—now known as Sunlenca—in December.