The latest from CDMOs, CMOs, and suppliers featuring Evonik, Lonza, Catalent, Stevanato, Formulated Solutions, and AtomVie.  

Chemicals/Chemical API Manufacturing 
* AtomVie Announces Construction of Radiotherapy Mfg Facility   
Biologics Manufacturing 
* Catalent Expands AAV Platform for Gene Therapies 
Formulation Development/Drug Product Manufacturing 
* Evonik Opens New Lipid Mfg Facility  
* Lonza Upgrades Powder Characterization Capabilities 
* Formulated Solutions To Invest $44 M in Tennessee Mfg Facility 
Packaging 
* Stevanato Secures $137 M for ESG Projects, Expansion 

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Chemicals/Chemical API Manufacturing 

AtomVie Announces Construction of Radiotherapy Mfg Facility   
AtomVie Global Radiopharma, a Toronto, Canada-based CDMO of radiopharmaceuticals, has entered a lease agreement with Panattoni Development Company, a Hamilton, Ontario, Canada-based real estate company, for a new 64,000-square-foot facility for clinical and commercial GMP manufacturing and worldwide distribution of radiotherapeutics. 

The new facility is expected to be commissioned in 2024 and will increase the company’s production capacity more than 10 times. 

Thee company currently operates a CDMO facility at McMaster University in Hamilton, Ontario. The company was launched in August 2022 with the successful closing of series A financing of $40 million. AtomVie is a spinout of the Center for Probe Development and Commercialization, a McMaster University Center of Excellence. 

Source: AtomVie 

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Biologics Manufacturing 

Catalent Expands AAV Platform for Gene Therapies 
Catalent has expanded its UpTempo platform process for the development and cGMP manufacturing of adeno-associated viral (AAV) vectors. The platform now includes an in-house, clonal HEK293 cell line (a cell line isolated from the kidney of a human embryo) and off-the-shelf plasmids.  

Catalent launched its UpTempo platform in 2022, to standardize protocols for cell culture, transfection, and downstream purification, as well as implementing a single, uniform bill of materials to simplify the supply chain and material qualification.  

Source: Catalent 

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Formulation Development/Drug Product Manufacturing 

Evonik Opens New Lipid Mfg Facility 
Evonik, a producer of specialty and fine chemicals, including excipients, has opened a new GMP lipid manufacturing facility in Hanau, Germany, to provide lipids for clinical and small-scale commercial manufacturing.  

Lipids produced at the facility will serve a broad range of RNA and gene therapies, such as infectious disease control, cancer immunotherapy, and protein replacement therapies. With particle-engineering and purification capabilities, including chromatography, the lipid launch facility can support custom and proprietary lipids, including PEGylated lipids, phospholipids, and ionizable cationic lipids. 

The opening of the new facility is the latest in a series of investments by Evonik in lipid manufacturing for RNA and gene therapies. Last year (2022), the company announced a triple-digit million-dollar joint investment with the US government to build a new lipid production facility at its site in Tippecanoe in Indiana. Evonik also increased production capacities for the plant-derived cholesterol PhytoChol, a lipid used in lipid nanoparticles, at its site in Hanau, Germany. 

Source: Evonik 

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Lonza Upgrades Powder-Characterization Capabilities 
Lonza has enhanced its powder-characterization capabilities at its small-molecules site in Tampa, Florida. The facility has been upgraded to include universal powder-flow testing alongside automated particle-size and shape-analysis capabilities. The new powder flow tester can characterize powder-flow properties to provide insight for pharmaceutical processing and formulation. The site has also installed a new instrument that uses static image analysis techniques to characterize particles. This upgrade will improve the evaluation of powders used in inhalers, where the identification of particle size and shape can be critical. 

Source: Lonza 

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Formulated Solutions To Invest $44 M in Tennessee Mfg Facility 
Formulated Solutions, a Largo, Florida-based CDMO of drug products, has announced a further investment of $43.6 million in its Cleveland, Tennessee manufacturing facility, which it acquired last month (February 2023). The company acquired the 455,000-square-foot facility in February 2023 and said that it would exceed a combined one million square feet by the end of 2023. The company specializes in topical and nasal formulations in semi-solid, aerosol, and liquid formats. 

With the facility acquisition and expansion, the company plans to create 524 new jobs in Bradley County, Tennesse, with plans to hire 380 new staff members and extend job offers to most of the former employees of the facility. 

Source: Tennessee Department of Economic & Community Development 

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Packaging 

Stevanato Secures $137 M for ESG Projects, Expansion 
Stevanato Group, a Piombino Dese, Italy-based provider of drug-containment, drug-delivery, and diagnostic products and services, has entered two separate agreements with BNL BNP Paribas, an Italian bank, and Cassa Depositi e Prestiti Group (CDP), an Italian investment bank, to obtain environmental, social, and governance (ESG)-linked funds to support its ongoing global expansion, in deals totaling EUR 130 million ($137 million). 

BNL BNP Paribas is participating in the financing with a contribution of EUR 70 million ($74 million), which is tied to two ESG-related objectives, including increasing the company’s renewable-based energy and waste-management improvements. An additional EUR 60 million ($63 million) is being financed by CDP to be allocated to new investments in technological innovation, the purchase of machinery, and the modernization of a production plant in Italy. 

Source: Stevanato Group