MilliporeSigma, Aceto, PCI Pharma Services, Maravai Expand
The latest from CDMOs, CMOs, and suppliers featuring MilliporeSigma, Aceto, PCI Pharma Services, Maravai LifeSciences, and Univercells.
Biologics Manufacturing
MilliporeSigma Invests $30 M To Add Single-Use Assembly Production Line
MilliporeSigma plans to invest $30 million by adding a single-use assembly production unit at its Life Science Center in Molsheim, France.
The company will add 18,300 square feet of ISO7 or ISO5 cleanrooms using modular building design and existing infrastructure. The new unit will produce Mobius single-use assemblies, which are used in COVID-19 vaccines and other vaccines/drugs. The expansion is planned to be operational by the end of 2021.
Molsheim will be the first site in Europe to manufacture the product. Other production sites making the product are in Danvers, Massachusetts, and Wuxi, China. With more than 1,700 employees and producing more than 10,000 products, the Molsheim hub is MilliporeSigma’s third largest site globally.
The $30-million investment is in addition to other recently announced company expansions as part of a multi-year investment program. Other sites with expansions are in the following locations: Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California; Madison, Wisconsin; Jaffrey, New Hampshire; and Danvers, Massachusetts. At the Danvers site, MilliporeSigma is working to double single-use production capacity by the end of 2021.
Source: MilliporeSigma
Aceto To Expand Bioreagent Offering to Support Biopharma, Cell-Culture Mfg
Aceto, a Port Washington, New York-based manufacturer of specialty materials for the life-sciences and advanced technology markets, plans to expand its portfolio for biopharmaceutical and cell-culture reagent manufacturers.
The biopharma and cell culture offering will consist of raw materials, including nucleotides, nucleosides, and bio-buffers as well as cell-culture media ingredients, such as amino acids and vitamins. The ingredients can be applied in hybridoma and Chinese hamster ovary (CHO) cell-culture media.
This offering will be built on the expertise of Pharma Waldhof, one of Aceto’s facilities located in Düsseldorf, Germany. The biopharma and cell-culture portfolio will use Pharma Waldhof’s global manufacturing and distribution capabilities, filling and packing, and experience as a supplier to global biopharma and cell-biology industries.
Source: Aceto
Maravai Launches Plasmid DNA Mfg Services Through CDMO
Maravai LifeSciences, a provider of reagents for nucleic acid synthesis, bioprocess impurity detection and analysis, and protein labeling, has expanded capabilities at its CDMO business, TriLink BioTechnologies, with the launch of plasmid DNA (pDNA) manufacturing services.
TriLink’s pDNA capabilities offer manufacturing for GMP-grade plasmid and can be customized with the company’s flexible GMPLink grade. Its 118,000-square-foot manufacturing facility includes seven suites dedicated to plasmid development and production.
Source: Maravai LifeSciences and TriLink BioTechnologies
Univercells Names New CEO
Univercells, a technology company specializing in bioprocessing, has appointed Mathias Garny as the Chief Executive Officer of Univercells Technologies, a Univercells bioprocessing technology company.
Univercells Technologies was launched in February 2020 following its carve-out from Univercells and an EUR 50 million ($54 million) investment by Gamma Science, a life-sciences company backed by the investment firm, KKR.
Already acting as General Manager, Mr. Garny has been responsible for overseeing the company’s operations and leading the strategy development and implementation.
Mr. Garny first joined Univercells in 2015 as Chief Financial Officer and later become Chief Commercial Officer in 2017.
Source: Univercells
Packaging
PCI Expands Cold-Chain Clinical Supply Capabilities
PCI Pharma Services, a CDMO and contract provider of packaging services, has expanded cold-chain, clinical-supply storage and distribution capabilities at its Berlin, Germany site.
PCI added capacity and several new cold-chain storage conditions to its capabilities, including temperatures from controlled-room temperature to -80 °C. The company has doubled the size of its 2-8 °C storage and added -20 °C and -80 °C. PCI says it will be adding liquid-nitrogen storage capabilities at the Berlin site in Phase Two of the expansion, set to begin in fiscal year 2022.
The Berlin facility recently passed mandatory regulatory inspection for these expansions, and it is now fully operational. The Berlin facility provides secondary packaging, storage of pharmaceutical and biopharmaceutical therapies at all temperature ranges, and distribution.
This expansion is the latest in series of global clinical expansions PCI has at other sites, including: (1) San Diego, California; (2) Rockford, Illinois; (3) Bridgend, UK; and (4) Australia. PCI completed a new Clinical Center of Excellence at its Berlin location in July 2020 following the acquisition of Bellwyck Pharma Services in early 2020.
Source: PCI Pharma Services
