Lonza To Expand API Mfg in China; WuXi STA Names Location for New US SiteBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, WuXi STA, Catalent, Cytiva, Novasep, Cerobis-Pharma, Almac, Viralgen, CGT Catapult, and Evotec.
Chemicals/Chemicals API Manufacturing
Lonza Investing $22 M To Expand API Labs, Mfg Facility in China
Lonza is investing more than CHF 20 million ($22 million) to expand its laboratories and mid-scale manufacturing assets at its API manufacturing center in Nansha, China.
The expansion will include six 1,000-L small-molecule reactors, four 1,500-L vessels, and isolation equipment to provide mid-scale capacity to bridge between early-phase and late-phase production. The additional laboratories will be able to develop and manufacture highly potent APIs.
The expanded laboratories and manufacturing facilities at Nansha are expected to come on line between the first and third quarters of 2022. Approximately 250 employees now work at Lonza’s Nansha site, and the expansion is expected to create around 70 new positions.
Novasep Investing $7.3 M To Upgrade API Mfg Facility
Novasep is investing EUR 6.1 million ($7.3 million) over three years to upgrade its API manufacturing facility at its site in Mourenx, Pyrénées-Atlantiques, France.
The upgrade to the facility includes the installation of new equipment and revamping of cleanrooms for API isolation.
This project has been selected as part of a recovery plan initiated by the French government. Novasep will be supported within the framework of an investment program that rewards industrial investments in order to allow France to increase economic growth and employment potential. The project will create seven full-time jobs on this site.
WuXi STA Names Middletown, Delaware as Location of New US Mfg Site
WuXi STA, a subsidiary of WuXi AppTec, has named Middletown, Delaware as the location of its new pharmaceutical manufacturing campus.
The WuXi STA Middletown site is expected to open in 2024 and aims to bring about 500 new full-time jobs to Delaware by 2026.
WuXi STA currently provides pharmaceutical development and manufacturing services for over 470 partners globally, covering small molecules and novel molecular modalities such as oligonucleotide, peptide, and various complex conjugates. The future Middletown site will become WuXi STA’s second site in the US and will have clinical- and commercial-scale manufacturing capabilities.
WuXi STA’s current project plan is an initial phase for this new campus. Subsequent phases could further expand its campus in Middletown to a total workforce of more than 1,000 employees.
Source: WuXi AppTec
Swissmedic OKs Cerbios-Pharma’s New HPAPI Mfg Plant
Cerobis-Pharma, a Lugano, Switzerland-based CDMO for high potency active pharmaceutical ingredients (HPAPIs), recombinant proteins and antibody drug conjugates, has received approval from Swissmedic, the national pharmaceutical regulatory agency in Switzerland, for its new HPAPI production plant.
This new production line is dedicated to highly active products with containment allowing occupational exposure limits up to 30 ng/m3 and enabling manufacture up to 35-kg batch size. The new plant features reactors up to 1000 L and a pressure-filter-dryer.
Almac Invests in Equipment to Support Solid-Form Screening
Almac, a CDMO of APIs and drug products, has invested approximately £350,000 ($481,538) in an automated crystallization platform to support solid-form screening of polymorphs, salts, and crystals in addition to crystallization of amorphous materials. A new Empyrean X-ray powder diffractometer, which allows X-ray powder diffraction analysis of samples, represents a further £250,000 ($343,950) investment by the company.
Catalent To Acquire RheinCell Therapeutics
Catalent has agreed to acquire RheinCell Therapeutics, a Langenfeld, Germany-based developer and manufacturer of human induced pluripotent stem cells (iPSCs).
iPSCs are cells that can be differentiated into various cell types to address a range of therapeutic indications. Founded in 2017, RheinCell has undertaken research and development of full human leukocyte antigen-matched cell banks as well as invested in development-scale operational capabilities. Upon closing, RheinCell’s current employees will join Catalent’s Cell & Gene Therapy business.
The deal is expected to close before the end of 2021, subject to customary conditions.
Source: Catalent and RheinCell Therapeutics
Viralgen Opens New AAV-Gene-Therapy Mfg Facility
Viralgen, a CDMO specializing in the production of adeno-associated virus-based gene therapies and part of Bayer, has opened a new commercial production facility in San Sebastian, Spain.
The new facility, located in the same technology park as Viralgen’s existing manufacturing footprint, will enable early preclinical to commercial scale projects. Equipment validation and facility certification activities will continue throughout 2021 with the first commercial-grade 2,000-L batches able to be released by mid-2022.
This expansion represents investments of more than EUR 70 million ($83 million) for the first phase of the project and will reach EUR 120 million ($142 million) when two additional buildings are completed. The new commercial facility will create 130 new positions to bring total employees of more than 250 people in 2022.
Viralgen was formed in 2017 as a joint venture between Asklepios BioPharmaceutical (AskBio), a Research Triangle Park, North Carolina-based clinical-stage gene-therapy company, and Columbus Venture Partners. Viralgen was acquired by Bayer upon closing of Bayer’s $4-billion acquisition of AskBio in 2020.
Cytiva Acquires Intermountain Life Sciences
Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in 2020, has acquired Intermountain Life Sciences, a West Jordan, Utah-based manufacturer of high-purity water, buffers, and liquid cell-culture media.
Cytiva will use Intermountain’s manufacturing site in Utah to boost its liquid cell-culture media production. The Intermountain site and its capabilities will become part of Cytiva’s cell-culture media portfolio, which currently employs more than 700 people at its Logan, Utah facilities.
CGT Catapult To Launch Labs, Offices in Scotland
The Cell and Gene Therapy Catapult (CGT Catapult), a center of excellence funded by Innovate UK, the UK government’s innovation agency, will establish offices and laboratories in Edinburgh, Scotland.
With this expansion, the CGT Catapult aims to provide additional regionally focused support to the cell- and gene-therapy sector to accelerate product development, clinical trials, and adoption.
CGT Catapult Edinburgh is a collaboration with the University of Edinburgh and will be located at the Institute for Regeneration and Repair. The center will work with the academic and pharmaceutical services community in central Scotland.
Source: The Cell and Gene Therapy Catapult
Evotec Acquires Mfg Site from GSK
Evotec, a Hamburg, Germany-based drug-discovery and development company, has acquired a former GlaxoSmithKline’s site in Verona, Italy. The site has technologies and services needed to develop drug-discovery projects, including INDiGO, the company’s service for accelerated drug development and API manufacturing, pre-formulation, and cGMP manufacturing of drug products.
Evotec has been operating at the Verona site since acquiring Aptuit, a Greenwich, Connecticut-based pharmaceutical services company, in 2017 and currently employs approximately 750 employees at the site. Both the existing buildings as well as a plot hold potential for further expansion.