Yposkesi To Expand Cell, Gene-Therapy Mfg; Dendreon Launches CDMO
The latest from CDMOs, CMOs, and suppliers featuring Yposkesi, Dendreon Pharmaceuticals, Evonik, and Mikart.
Yposkesi Starts Construction of Cell, Gene Therpay Mfg Facility
Yposkesi, a Corbeil-Essonnes, France-based CDMO specializing in cell and gene therapies, has announced plans to construct its second commercial cell- and gene-therapy manufacturing facility.
Yposkesi is investing EUR 58 million ($70 million) in the new 5,000-m2 site. Earlier this year (2021), SK pharmteco, a Rancho Cordova, California-headquartered CDMO, took a majority equity stake in Yposkesi.
The new facility will double Yposkesi’s production surface area to 10,000 m2. The new building will house two additional production lines with several 1,000-L scale bioreactors. Construction began in May (May 2021) on a site adjacent to Yposkesi’s current 5,000-m2 commercial facility, which operates multiple manufacturing suites for bulk drug substance (up to 1,000 L) and fill–finish.
By 2023, the company says equipment consisting of several 1000-L bioreactors, chromatography and purification skids will be installed. The new facility will also incorporate a centralized warehouse, capacity for media, solutions, and mountings preparation as well as drug-substance production suites, storage, and quality-control lab resources.
Dendreon Forms CDMO Business for Cell Therapies
Dendreon Pharmaceuticals, a Seal Beach, California-based bio/pharmaceutical company of cell therapies, has formed a CDMO business.
The company’s 180,000-plus-square-foot manufacturing facility in Seal Beach will serve as the contract manufacturing services hub. Its Seattle, Washington facility will serve as the process development and manufacturing sciences center.
Source: Dendreon Pharmaceuticals
Formulation Development/Drug-Product Manufacturing
Evonik, Stanford Enter in Research Pact for mRNA Delivery
Evonik, a specialty and fine chemicals producer, has partnered with Stanford University to develop a mRNA delivery platform beyond the capabilities of lipid nanoparticles (LNPs).
Starting this month (June 2021), Evonik and Stanford will begin a three-year sponsored research collaboration to develop the polymer-based drug-delivery system, which Evonik will license and commercialize. The new polymer-based platform complements Evonik’s existing portfolio of lipid-based drug delivery platforms, including LNPs.
Evonik will work with Stanford University scientists to scale up the synthesis and formulation, and further develop the technology for organ-selective delivery based on a non-animal-derived, synthetic degradable polymer. Evonik says it aims to make this technology available for use in clinical-stage development and ultimately on a commercial scale.
Mikart Adds Equipment for Bilayer Tablets
Mikart, an Atlanta, Georgia-based CDMO specializing in modified-release formulations, has acquired new equipment, the Korsch XM12, to support the development of fixed-dose combination products and potent compounds that require compression technology for bilayer and mini tablets.