Supplier News: Cambrex, WuXi STA, Fujifilm & More
The latest from CDMOs, CMOs, and suppliers featuring Cambrex, Fujifilm Irvine Scientific, WuXi Biologics, WuXi STA, Catalent and Oxford Biomedica.
Chemical API Manufacturing
* Cambrex To Acquire Snapdragon Chemistry
* Fujifilm Investing $188 M for a New Cell-Culture Media Mfg Facility
* WuXi Biologics Launches New Biologics Development, Mfg Center
* Oxford Biomedica Appoints New CEO
Formulation Development/Drug Product Manufacturing
* WuXi STA Launches Parenteral Formulation Manufacturing Line
* Catalent Completes Expansion of Clinical Supply Facility in China
Chemicals/Chemical API Manufacturing
Cambrex To Acquire Snapdragon Chemistry
Cambrex has agreed to acquire Snapdragon Chemistry, a Waltham, Massachusetts-based provider of flow-chemistry process design and technology development services.
Snapdragon specializes in active pharmaceutical ingredient batch and continuous flow process development. Snapdragon has 74 employees and recently opened its second facility, a new 51,000-square-foot facility that expanded the company’s capacity for supplying clinical intermediates and drug substances.
The transaction is expected to close following the completion of customary regulatory approvals.
Fujifilm Investing $188 M for a New Cell-Culture Media Mfg Facility
Fujifilm Irvine Scientific, a subsidiary of Fujifilm Corporation and a supplier of media for bioprocessing, has announced a $188-million investment to establish a cell-culture media manufacturing facility in Research Triangle Park, North Carolina.
The 250,000-square-foot facility will support cGMP manufacturing of animal component-free, dry-powder, and liquid media by adding additional production capacity of 800,000 Kg/year for dry powder, 3,300,000 L/year for liquid, and 40,000 L/day of water for injection.
Land development and construction are scheduled to start in the spring of 2023 with operation of the facility beginning in 2025.
Fujifilm Irvine Scientific currently operates cell-culture media manufacturing facilities in California, the Netherlands, and the Saitama and Aichi prefectures in Japan.
Source: Fujifilm Irvine Scientific
WuXi Biologics Launches New Biologics Development, Mfg Center
WuXi Biologics, a Wuxi, China-based contract biologics manufacturer, has launched an integrated biologics contract research, development, and manufacturing center in the Fengxian district, Shanghai, China.
WuXi Biologics is adding development and manufacturing capacity at the center, with process development, analytical development, drug-product development and quality control capabilities as well as pilot-scale manufacturing, clinical drug-substance manufacturing and drug-product manufacturing. The company is adding a drug-substance facility and two drug- product facilities with their GMP release slated in 2023.
Construction on the 1.6 million-square-foot center began in November 2018. The initial phase, which became operational in 2020, provides biologics research services from target evaluation, reagent generation, antibody generation, lead optimization, complex biologics discovery, pre-clinical candidates identification to investigational new drug candidate selection. The center is WuXi Biologics’ ninth operational site in China.
Source: WuXi Biologics
Oxford Biomedica Appoints New CEO
Oxford Biomedica, an Oxford, UK-based cell- and gene-therapy company and CDMO, has appointed Dr. Frank Mathias, most recently CEO of Rentschler Biopharma, a Laupheim, Germany-based CDMO of biologics, as CEO and Board Director, effective March 2023. Dr. Mathias succeeds Dr. Roch Doliveux, who is Oxford Biomedica’s current interim CEO.
Dr Mathias has over 30 years of experience and has served as CEO of Rentschler Biopharma since 2016. He will return to Rentschler Biopharma’s Supervisory Board to March 2023 and will continue to be responsible for business operations while the Rentschler Biopharma’s Supervisory Board searches for a successor to be the company’s new CEO.
Dr Roch Doliveux will remain as Interim CEO of Oxford Biomedica until March 2023, at which point Dr Mathias will fully take over the role of CEO and Dr Doliveux will resume the role of Non-Executive Chair.
Formulation Development/Drug Product Manufacturing
WuXi STA Launches Parenteral Formulation Manufacturing Line
WuXi STA, a Wuxi, China-based CDMO of active pharmaceutical ingredients (APIs) and drug products and a subsidiary of WuXi AppTec, has begun the operation of a new parenteral formulation manufacturing line at its drug-product site in Wuxi City, Jiangsu Province, China. It is the second line opened by WuXi STA this year (2022) for parenteral drug-product clinical and commercial manufacturing and has an annual capacity of 10 million units.
The new line has a fully automatic vial loading/unloading system and a built-in 15 m2 lyophilizer in a fully enclosed isolator. The filling line supports vials in a full range of sizes for solutions and lyophilized powder while allowing switches between modes. The filling speed can reach 200 vials per minute.
To continue enhancing its injectable platform capabilities, WuXi STA is adding at the Wuxi City site a high-potency parenteral formulation manufacturing line, which is slated to begin operations in the third quarter of 2023. In addition, injectable formulation development and manufacturing services will be available from the company’s new site in Middletown Delaware, in 2025.
Source: WuXi STA
Catalent Completes Expansion of Clinical Supply Facility in China
Catalent has completed an expansion of its clinical supply facility in the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China.
The expansion has added approximately 30,000 square feet, which has allowed the installation of additional refrigerated (between 2 and 8 degrees Celsius) and deep-frozen (between minus 70 and minus 90 degrees Celsius) storage, with secondary packaging capabilities to be expanded.
The Waigaoqiao facility is one of two clinical supply facilities that Catalent operates in Shanghai, the other being in Tangzhen, outside the FTZ.