Catalent To Invest $30 M for European Center of Excellence; Marken ExpandsBy
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Stevanato Group, ChemWerth, Marken, and Polpharma Biologics.
Chemicals/Chemical API Manufacturing
ChemWerth Files for Drug Master File with FDA
ChemWerth, a supplier of generic active pharmaceutical ingredients (APIs), has filed a drug master file (DMF) with the US Food and Drug Administration (FDA) for clevidipine, a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure, making it the company’s 500th DMF in the company’s history. ChemWerth filed its first DMF in 1987.
ChemWerth is an API supplier with capabilities to support both large and small finished dosage companies. Through development and partnerships with API manufacturers, the company has a proprietary product selection process and product portfolio.
Polpharma Biologics Updates Facility Expansion in Poland
Polpharma Biologics, a Gdańsk, Poland-based biologics CDMO, has provided an update to the integration of its offerings and an expansion at its facility in Warsaw, Poland.
Polpharma Biologics reports that an expansion of its facility in Warsaw is in the final stages of completion and will add four single-use bioreactors trains offering drug-substance manufacturing at 500-L– 2,000-L scales and will be ready for clinical and commercial supply in 2021. The site has been designed for further capacity expansion with space for a further six 2,000-L bioreactors.
In addition, the company has integrated its site in Utrecht, Netherlands site, acquired from Bioceros, a biologics CDMO in 2016, and Bioceros’ cell-line development services into Polpharma’s existing biologics development and manufacturing offering and has retired the Bioceros name. In 2016, Polpharma Biologics acquired Bioceros and its proprietary cell-line development platform, CHOBC, as well as its discovery, process development, and analytical capabilities.
Source: Polpharma Biologics
Formulation Development/Drug-Product Manufacturing
Catalent to Invest $30 M for European Center of Excellence
Catalent plans to invest $30 million at its facility in Limoges, France to create a European center of excellence for clinical biologics, formulation development, and drug product fill–finish services.
The Limoges site will be modernized to handle large-molecule programs with additional capacity for small-molecule dosage form development. The 180,000-square-foot facility will include the installation of an Optima high-speed flexible line capable of filling vials, syringes, or cartridges under barrier isolator technology as well as enhancements to its analytical and quality control laboratories. The expansion is scheduled to begin in September (September 2020) with completion anticipated in 2022. Catalent says it plans to gradually hire approximately 80 additional employees to support the center.
The project is being supported by the Prefecture of Haute-Vienne, the Metropolitan Area of Limoges, the Limoges Haute-Vienne Chamber of Commerce and Industry and the Regional Council of Nouvelle Aquitaine, the managing authority for policies and financial support for innovation in the region, with a grant of EUR 1.3 million ($1.5 million).
Stevanato Group, Colanar in Pact to Support Fill-Finish Testing
Stevanato Group, a producer of glass primary packaging, headquartered in Padua, Italy, has signed an agreement with Colanar, a Deep River, Connecticut-based company, for small-batch pharma filling machines.
Stevanato will equip its new US Technology Excellence Center (US TEC) in Boston, scheduled to open on September 24, 2020, with Colanar’s fill-finish machine to perform analytical characterization and determine factors impacting container-closure systems.
Colanar’s modular filling system is developed for the filling and vacuum-stopper placement of ready-to-use nested vials, cartridges, and syringes. The system will allow Stevanato’s US TEC scientists to fill glass containers with buffers, placebos, and drug products and immediately test them to provide data about the impact of the filling process on a formulation and container closure-system.
Source: Stevanato Group
Marken Adds Clinical Depots in LA and Ukraine
Marken, a provider of clinical-trial supply and logistics services and a subsidiary of UPS Healthcare, has announced it is adding a depot in Los Angeles, California and a new depot in Kiev, Ukraine. In addition, two logistics branches will be added in Dublin, Ireland and Amsterdam. These additions add increased capacity and enables Marken to continue to offer supply-chain services.
The Amsterdam facility will include a cryogenic filling station for cell and gene therapies. An additional liquid nitrogen service station has been added to Marken’s network in Geneva, Switzerland.
By the early fourth quarter of 2020, Marken says it will have 12 fully operational depot locations, complemented by more than 10 million square feet of commercial warehouse space in 56 UPS Healthcare distribution centers.