Supplier News: F.I.S., WuXi STA, Seqens & More
The latest from CDMOs, CMOs, and suppliers featuring F.I.S., Delmar, WuXi STA, Seqens, Ginkgo Bioworks, Berkshire Sterile Manufacturing, Aenova, Galtiva, Cytiva, Recipharm, and Microsize.
Chemical API Manufacturing
* Bain Capital To Acquire F.I.S.; Minafin Acquires Delmar
Biologics Manufacturing
* Seqens In Talks with Novartis To Acquire CellforCure
* Ginkgo Bioworks In $18-M Biomanufacturing Pact with US Gov’t
Formulation Development/Drug Product Manufacturing
* WuXi STA Launches High Potency Sterile Injectable Mfg Line
* Berkshire Sterile Manufacturing To Expand Lyophilization Capacity
* Aenova, Galvita Partner for Pediatric, Geriatric Dosage Forms
* Cytiva Launching Lipid Nanoparticle Platform
* Microsize Invests in The Solubility Company
General
* Recipharm Opens Analytical Lab for Testing in India
Chemicals/Chemical API Manufacturing
Bain Capital To Acquire F.I.S.; Minafin Acquires Delmar
Bain Capital Private Equity has agreed to acquire Fabbrica Italiana Sintetici (F.I.S.), a Vicenza, Italy-based CDMO of active pharmaceutical ingredients (APIs).
F.I.S. is owned by the Ferrari Family, and Bain Capital is buying 100% of the stock for F.I.S. from Nine Trees Group, the holding company of the Ferrari Family. The transaction remains subject to approvals by competent regulatory authorities.
In 2022, F.I.S. generated sales of approximately EUR 700 million ($781 million), with a network of three manufacturing facilities based in Italy and employing more than 2,000 people, including 250 R&D scientists.
In a related transaction, Minafin, which holds several fine chemical developers and manufacturers, including Minakem, has acquired the Montreal operations of Delmar, a CDMO of generic APIs and formerly part of F.I.S. The Montreal plant has 174 m3 of reaction capacity and manufacturing permits for controlled substances as well as veterinary active ingredients.
Source: Bain Capital and Minafin
Biologics Manufacturing
Seqens In Talks with Novartis To Acquire CellforCure
Seqens has entered negotiations with Novartis for the potential acquisition of Novartis’ CELLforCURE, a Les Ulis, France-based CDMO of biologics, and CELLforCURE’s cell & gene therapy development and production site.
The facility has annual production capacity of several hundred therapeutic batches and over 10,000 m² in space, including six independent GMP manufacturing suites and large-scale GMP production services for clinical and commercial projects for cell and gene therapies.
In case of a positive outcome of the negotiations between Seqens and Novartis, the execution of any contractual documents related to this potential acquisition will remain subject to the mandatory information and consultation of the competent employee representative bodies.
Source: Seqens
Ginkgo Bioworks In $18-M Biomanufacturing Pact with US Gov’t
Ginkgo Bioworks, a Boston-based biotechnology company specializing in cell engineering for industrial applications, has entered a four-year contract worth up to $18 million with the Defense Advanced Research Projects Agency (DARPA), part of the US Department of Defense, for the manufacture of complex therapeutic proteins.
Source: Ginkgo Bioworks
Formulation Development/Drug Product Manufacturing
WuXi STA Launches High Potency Sterile Injectable Mfg Line
WuXi STA, a CDMO of active pharmaceutical ingredients (APIs) and drug products and a subsidiary of WuXi AppTec, has launched a high-potency (HP) sterile injectable manufacturing line at the company’s drug-product site in Wuxi City, China.
The new HP injectable manufacturing line has an annual capacity of 12 million units. Meeting occupational exposure limits as low as 10 ng/m3, the new line utilizes fully enclosed isolation systems and automated filling machines. The line is equipped with two 20-m2 lyophilizers and supports liquid and lyophilized vials of various specifications, with a filling rate of up to 200 units per minute.
The Wuxi City drug product site currently has two fully automated sterile injectable manufacturing lines, with manufacturing capacity of 2 million and 10 million units annually, respectively. These lines support various dosage forms, including liquid and lyophilized vials, pre-filled syringes, and cartridges. In addition, the company’s sterile lipid nanoparticle platform has also started operation at the Wuxi City site, with a batch production capacity ranging from 10 to 50 liters to support the formulation development of complex new modalities, including oligonucleotide-based drug candidates.
By 2024, WuXi STA plans to add two more injectable manufacturing lines at the same site, with additional lines also set to be added to its site in Couvet, Neuchâtel, Switzerland, and upcoming site in Middletown, Delaware.
Source: WuXi STA
Berkshire Sterile Manufacturing To Expand Lyophilization Capacity
Berkshire Sterile Manufacturing (BSM), a Lee, Massachusetts-based CDMO of fill–finish and lyophilization services, has announced plans to double its lyophilization capacity for its automated, isolator-based filling line. A second lyophilizer will be added to the line to increase capacity to 70,000 10R vials per run.
BSM’s current lyophilization capacity on the line is 35,000 10R vials, and the addition of the redundant lyophilizer will double that capacity to 70,000 10R vials. The company expects to lyophilize GMP lots on the new lyophilizer by the fourth quarter of 2025.
Source: Berkshire Sterile Manufacturing
Aenova, Galvita Partner for Pediatric, Geriatric Dosage Forms
Aenova, a CDMO of drug products, and Galvita, a Basel, Switzerland-based start-up company specializing in age-specific dosage forms, have entered a partnership for the development, formulation, and production of oral dosage forms. Galvita has specific expertise in child- and senior-friendly formulations that feature faster oral disintegration, better taste-masking, and higher drug loading.
Galvita’s templated-inverted particles (TIP) technology consists of clinically tested calcium-phosphate microcapsules that can be loaded with a wide variety of active ingredients via a self-loading mechanism. The capsules are then processed into tablets. These tablets have the property of disintegrating almost instantly upon ingestion, releasing the active ingredient. As Galvita’s strategic industrial CDMO partner, Aenova will offer this technology for customer projects at its site in Sisseln, Switzerland. Aenova’s Sisseln site is the company’s Competence Center for complex solids within the Aenova network and develops and produces oral solid dosage forms.
Source: Aenova
Cytiva Launching Lipid Nanoparticle Platform
Cytiva is launching a new platform, NanoAssemblr, built for clinical and commercial manufacturing of lipid nanoparticle medicines. The platform is expected to be available in the fourth quarter of 2024.
Source: Cytiva
Microsize Invests in The Solubility Company
Microsize, the former North American micronization business of Lonza, has made an investment in and formed a partnership with The Solubility Company, a Helsinki, Finland-based CRO specializing in physicochemical measurement services. Microsize’s investment accelerates plans for The Solubility Company to open a US-based solubility lab in Microsize’s facility in Quakertown, Pennsylvania. The Solubility Company’s single particle analysis (SPA) technology allows for continuous measurements of the dissolution process directly from powder samples using machine vision and artificial intelligence to provide solubility measurements in the developmental process.
Microsize will begin outfitting a discreet SPA lab and IT network along with customer visitation areas to allow The Solubility Company to begin testing samples in the US by the fourth quarter of 2023.
Source: Microsize
General
Recipharm Opens Analytical Lab for Testing in India
Recipharm, a CDMO of active pharmaceutical ingredients (APIs), advanced therapies, and drug products, has opened a new analytical lab in Bengaluru, India to enhance its global testing capabilities for nitrosamines, extractables and leachables, and elemental impurity testing.
Fully cGMP/cGLP compliant, the 5,000-square-foot lab will expand Recipharm’s existing analytical capabilities of oral solids, drug delivery, inhalation, vaccines and injectables.
Source: Recipharm
