Stevanato Opens Technology Excellence Center; PCI Launches New Digital Platform

The latest from CDMOs, CMOs, and suppliers featuring Stevanato Group, PCI Pharma Services, Almac, Hitachi Chemical, BioDuro, and Sundia.

Biologics Manufacturing

Hitachi Chemical Renames Regenerative Medicine CDMO Business
The regenerative medicine business of Hitachi Chemical, a Tokyo-based chemicals and industrial manufacturer, has adopted the name, Minaris Regenerative Medicine, for its CDMO business.

The wholly owned regional subsidiary companies and entities within Minaris Regenerative Medicine encompass a global footprint of over 200,000 square feet and an employee base of more than 500 and have adopted the Minaris name. In North America, Hitachi Chemical Advanced Therapeutics Solutions was renamed Minaris Regenerative Medicine, effective September 23, 2020. In Europe, apceth Biopharma GmbH was renamed Minaris Regenerative Medicine GmbH, effective September 23, 2020. In Asia, Hitachi Chemical’s Yokohama regenerative medicine facility adopted the use of Minaris Regenerative Medicine as its brand name.

Hitachi Chemical, the parent company of Minaris Regenerative Medicine, was renamed Showa Denko Materials, effective October 1, 2020.

Source: Minaris Regenerative Medicine

Formulation Development and Drug Product Manufacturing

Adare Pharmaceuticals Acquired by Investment Firms
The investment firms of Thomas H. Lee Partners and Frazier Healthcare have acquired Adare Pharmaceuticals, which will be rebranded Adare Pharma Solutions, a CDMO and provider of pharmaceutical technologies, from TPG Capital.

The acquisition includes Adare’s CDMO, pharmaceutical technology, and microbiome businesses. TPG Capital will retain rights to Adare’s Eosinophilic Esophagitis product, which has been spun out into a separate entity.

Source: Adare Pharmaceuticals


Stevanato Opens Technology Excellence Center in US
Stevanato Group, a producer of glass parenteral packaging headquartered in Padua, Italy, has opened its Technology Excellence Center (US TEC) in Boston, Massachusetts.

The center supports biopharma companies from early-phase development to commercialization in how to select the primary container for a biopharmaceutical product.

The company has also strengthened its offer at the US TEC through a network of strategic partnerships: container-closure integrity-testing with Pfeiffer Vacuum Technologies, a provider of vacuum technology and products; extractables and leachables testing with Nelson Labs, a provider of lab testing and advisory services; and small-scale fill–finish capabilities for evaluating container-closure systems with Colanar, a provider of fill–finish equipment.

Source: Stevanato Group

PCI Launches Digital Platform for Supply Chain Data, Analytics
PCI Pharma Services, a CDMO and contract provider of packaging services, has launched a digital platform to give visibility into clinical and commercial supply chain and to provide real-time data and insights.

The digital interface is called pci | bridge. The platform will make real-time information readily accessible to clients, including inventory, production, distribution, and shipping data, presented in organized, customizable formats. The platform also features a document repository where electronic paperwork can be stored and accessed in one place and signatures secured on the platform.

Source: PCI Pharma Services


Almac Expands Analytical Testing Services
Almac, a CDMO of APIs and drug products and a contract provider of analytical testing and clinical services, has expanded its existing suite of analytical solutions to include biologics testing.

Almac’s new services include: GMP lot release and stability testing to support drug-substance and drug-product programs for both novel biologics and biosimilars; fit-for-purpose analytical method development / phase-appropriate method validation; and raw material testing for microbial and mammalian expression systems.

This new offering follows the announcement of the company’s expansion of its Irish laboratory in 2019. The new biologics analytical testing services complement analytical services already offered by the company from its facility in Athlone, Ireland as well as at its global headquarter campus in Craigavon, UK and its facility in Pennsylvania. The recent investment will see an increase to its current workforce.

Source: Almac Group

BioDuro, Sundia Partner To Form New CRDMO
BioDuro, a San Diego, California-headquartered contract research, development and manufacturing organization, backed by Advent International, a Boston-based private-equity firm, has entered into a partnership with Sundia, a Shanghai, China-based contract research and manufacturing organization, to create a new contract research, development and manufacturing organizations (CRDMO) with operations in China and the US.

The combined company will operate as BioDuro-Sundia, providing drug discovery, development and manufacturing for both active pharmaceutical ingredients (APIs) and drug products. Advent led a majority investment in Sundia, with Bridgewest Capital as a co-investor. Financial terms were not disclosed.

BioDuro-Sundia has combined employees of over 2,000 employees across 10 sites globally, BioDuro-Sundia is expanding with two new sites in China: a R&D base in Wuxi City and a manufacturing center in Bengbu. In addition, the company says it will add more than 1,000 employees over the next two years (as reported on September 25, 2020).

Source: BioDuro and Sundia

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