Recro Acquires Irisys for $50 M; Curia Investing $35 M in Mfg ExpansionBy
The latest from CDMOs, CMOs, and suppliers featuring Recro Pharma, Curia, Vectura, Syngene, Xellia, Comar, Schott, and Aptar Pharma.
Chemicals/Chemical API Manufacturing
Curia To Invest $35 M To Expand Commercial Small-Molecule Mfg Capacity
Curia, formerly AMRI, is investing more than $35 million to expand its commercial small-molecule manufacturing capacity at its Rensselaer, New York facility.
The expansion will include new vessel capacities that more than double the site’s batch-size scaling and product output. The site currently produces APIs for more than 50 products.
The expansion is expected to be completed within 18 months (as reported on August 19, 2021), adding to Curia’s existing API manufacturing facilities in the US, France, Spain, Italy and India.
Syngene Expands Biomanufacturing Capacity
Syngene International, a Biocon subsidiary and Bangalore, India-headquartered contract research organization, has expanded its biomanufacturing capacity with the launch of a new microbial facility and expansion of its mammalian-cell manufacturing facility Bangalore, India.
The new microbial facility has two fermenters with 200-L and 500-L capacity and will enable the company to expand service offering for the manufacturing of plasmid DNA and mRNA. The expansion of the mammalian-cell manufacturing facility includes the addition of another 2000-L single-use bioreactor.
Source: Syngene International
Formulation Development/Drug-Product Manufacturing
Recro Acquires CDMO Irisys for $50 M
Recro Pharma, a CDMO of oral solid drug product based in Gainesville, Georgia, has acquired Irisys, a San Diego, California-based CDMO, for approximately $50 million in a combination of cash, shares of Recro common stock, and a seller promissory note.
Irisys provides formulation development to commercial manufacturing for various dosage forms, including oral liquids, sterile injectables, tablets, topicals, liquid/powder-filled capsules, ophthalmic droppers, liposomes and nano/microparticles.
The acquisition moves Recro’s technical focus focus beyond oral solid dose to include sterile injectables oral liquids, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes and nano/microparticles and adds new capabilities in the areas of aseptic fill–finish and lyophilization.
Irisys recently added automated, aseptic fil–finish and lyophilization capabilities to its existing facility in San Diego and expects to generate $15.4 million in revenue for full year 2021.
Xellia Opens Drug-Product Mfg Facility in Ohio
Xellia Pharmaceuticals, a pharmaceutical company and CMO, has opened its drug-product manufacturing site in Cleveland, Ohio and released the first anti-infectives manufactured at the site to be distributed for use by US hospitals. The anti-infective is the first drug product to be manufactured at the Cleveland site since it was bought by Xellia in 2015. The facility is now commercially active after operations commenced following the passing of an inspection by the US Food and Drug Administration in 2020.
In addition to commencing commercial supply, the facility is also preparing ramp-up of a newly installed aseptic-bag manufacturing line.
The Cleveland site operates alongside Xellia’s other manufacturing plants in Copenhagen, Denmark; Budapest, Hungary; and Taizhou, China. The network provides supply for both active pharmaceutical ingredients and finished dosage form products.
Source: Xellia Pharmaceuticals
Philip Morris Gains 29% Stake in CDMO Vectura
Philip Morris International (PMI), a cigarette and tobacco manufacture, reported this week (August 19, 2021) that shareholders holding 29.16 % of shares of Vectura, a CDMO of inhaled drug-delivery services, had tendered their shares to PMI as part of PMI’s deal to buy Vectura for £1.1 billion ($1.52 billion).
The purchase is part of a public tender offer process and follows the support given by the Board of Directors of Vectura for PMI’s 165-pence-per share bid for the company. Prior to the Vectura board recommending PMI’s bid earlier this month (August 2021), Vectura had been evaluating a competing bid for the company from The Carlyle Group, a private equity firm.
Vectura shareholders have until September 15 to decide whether to tender their shares to PMI. The proposed acquisition of Vectura is part of PMI’s “Beyond Nicotine” strategy, announced in February (February 2021), which set a goal to generate more than 50% of total net revenues (at least $1 billion) from smoke-free products by 2025.
Source: Philip Morris International
Comar Opens New Packaging Facility in California
Comar, a specialty packaging, device and component supplier, has opened a new packaging facility in Rancho Cucamonga, California.
The new 230,000-square-foot facility houses injection molding, injection blow-molding and injection stretch blow-molding cells. The project consolidates employees, equipment, and operations from Comar’s existing Rancho Cucamonga and Garden Grove, California plants into the facility. The site also has a design, development, and prototyping center to complement Comar’s current East Coast and Mid-West innovation and development hubs.
In the past 18 months (as reported on August 10, 2021), Comar has been undergoing a period of expansion by increasing its operational footprint by over 40% as it opens new manufacturing plants in New Jersey, Wisconsin, and California.
Schott, Serum Institute of India Form Packaging JV
The Serum Institute of India (SII), a Pune, India-based vaccine manufacturer, has acquired a 50% stake in Schott Kaisha, a joint venture of Schott, a specialty glass and materials company, and Kaisha Manufacturers. SII has acquired the 50% stake from former co-owners Kairus Dadachanji and Shapoor Mistry to set up its ownership in the joint venture with Schott.
Schott Kaisha is an India-based manufacturer of pharmaceutical packaging products such as vials, syringes, ampuls. and cartridges. SII is a manufacture of vaccines, including COVID-19 vaccines. Schott is providing glass vials globally to key vaccine manufacturers and has exceeded its target to deliver vials for more than 2 billion vaccine doses through 2021.
Aptar in License Option for High-Payload Drug-Powder Inhaler
Aptar Pharma, a provider of drug-delivery systems and services and active material science services, has acquired a license option for the worldwide rights to a proprietary high-payload dry-powder inhaler, Orbital, from Pharmaxis, a drug-development company.
Under the agreement, Aptar Pharma gains an exclusive 12-month option to acquire worldwide rights to Pharmaxis’ proprietary Orbital technology, which delivers large payloads of drug. Aptar Pharma will evaluate the commercial applications for the Orbital device and further develop the prototype device. Pharmaxis retains the rights to devices containing Orbital intellectual property used to deliver inhaled mannitol.
The Orbital technology allows powder payloads of up to 400 mg or more to be inhaled by patients in divided doses without the need to reload. This platform was originally developed as for Pharmaxis’ cystic fibrosis drug, Bronchitol (mannitol) and is also used to deliver high doses of other drugs, such as antibiotics, to the lungs.
Source: Aptar Pharma