Univercells Launches New CDMO; Xellia, Aphena, Cambrex Expand

The latest news from CDMOs, CMOs, and suppliers featuring news from Univercells, Xellia, Aphena, and Cambrex. 

Biologics Manufacturing

Univercells Launches CDMO Exothera
Univercells, a technology company specializing in bioprocessing, has launched Exothera, a viral vector CDMO targeting cell- and gene-therapy and vaccine developers, in a refurbished 161,000-square-foot facility in Jumet, Belgium.

The GMP areas at Jumet will contain Exothera’s CDMO activities and ongoing Univercells vaccine development and manufacturing initiatives, with capacity for rapid response programs. On the rapid response front, the company is currently pursuing support opportunities for COVID-19 vaccine innovators.

Source: Univercells

Formulation Development/Drug Product Manufacturing

FDA Approves Xellia Ohio Plant for Producing Drug Products 
Xellia Pharmaceuticals, a pharmaceutical company and CMO, has received approval from the US Food and Drug Administration (FDA) allowing the company to begin manufacturing drug products at its site in Cleveland, Ohio.

Since acquiring the Cleveland site in 2015, Xellia has made investments to create a facility that will allow the company to continue to provide supply of its anti-infective products across the US. Xellia has worked closely with the FDA to resume activities at the site, and in January 2020, the FDA performed a comprehensive cGMP inspection of the facility.

Xellia can now initiate commercial manufacturing at the Cleveland site and will use the facilities to start production of aseptic injectables. The increased capacity will be used for Xellia’s production lines for its anti-infective injectable drug products. Xellia will also use the site to widen its offering of CMO services for third-party injectables.

Until now, the focus at the Cleveland site was on packaging, labelling and distributing drug products manufactured at other Xellia facilities, following the first FDA approval for the facility in 2016.

Source: Xellia Pharmaceuticals 


Aphena Invests $12.5 M To Expand Maryland Facility
Aphena Pharma Solutions, a provider of contract packaging and manufacturing services, has acquired an additional 54,000-square-foot facility adjoining its current 110,000-square-foot facility in Easton, Maryland. Aphena bought the property from Konsyl Pharmaceuticals after Konsyl decided to divest the facility in 2019.

Building renovations and the installation of new equipment have already begun (March 2020), with an estimated completion date of October 2020. Aphena currently employs 150 full-time workers and plans to add an additional 100 jobs at this location over the next two years. The acquisition of the Konsyl property plus the planned renovations represent a $12.5-M investment by Aphena in the Easton facility over the past 12 months.

Source: Aphena Pharma Solutions


Cambrex Completes Expansion of Analytical Testing Capabilities
Cambrex, a CMO of small-molecule active pharmaceutical ingredients and drug products, has completed an expansion of its biopharmaceutical analysis capabilities at its site in Durham, North Carolina. Biopharmaceutical analysis services were launched at Durham in 2018 and have since been expanded through the purchase and implementation of various method development, validation, release and stability or endotoxin testing functions.

Following the expansion, the Durham site features a range of instruments, including particle analysis, imaging, qPCR, fluorescent/absorbance plate reader, immunoblotting, mass spectrometry and other compendial testing apparatus. The capabilities are applicable to a variety of biopharmaceuticals, including bacteriophage/bacterial virus and mammalian viral infectious titer assays for intermediates, drug substances, and final drug products.

The company says that ongoing assay additions are also planned at Durham, including impedance based orthogonal methods for existing and new cell-based potency assays, and protein-protein interaction/binding assays.

Source: Cambrex

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