The latest from CDMOs, CMOs, and suppliers featuring Catalent, Experic, Stevanato, and Colorcon. 

Biologics Manufacturing 
* Catalent Opens Plasmid DNA Mfg Facility 
Formulation Development/Drug Product Manufacturing 
* Experic Adds New Analytical Lab 
* Colorcon To Acquire Airnov Healthcare Packaging 
Packaging 
* Stevanato, Transcojet Partner in Prefillable Syringes 

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Biologics Manufacturing 

Catalent Opens Plasmid DNA Mfg Facility 
Catalent has opened a new commercial-scale plasmid DNA (pDNA) manufacturing facility at its European Center of Excellence for Cell Therapies in Gosselies, Belgium. 

The facility contains over 12,000 square feet of development and manufacturing space across multiple cleanrooms for the dedicated production of cGMP-grade pDNA for clinical and commercial supply. It has been designed to support requirements for high-yielding processes at 50- and 300-liter fermentation scale to enable batch sizes from milligram to multi-gram scale. The new will also produce a new range of off-the-shelf plasmids. 

In December 2022, Catalent opened a cell-therapy commercial manufacturing facility, also located on the Gosselies campus. The facility houses 60,000 square feet of dedicated cell-therapy manufacturing space housing multi-product, segregated suites designed to support autologous and allogeneic cell-therapy manufacturing. 

Source: Catalent 

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Formulation Development/Drug Product Manufacturing 

Experic Adds New Analytical Lab 
Experic, a Cranbury, New Jersey-based CDMO of drug products, has expanded its analytical laboratory and services with a new laboratory in Cranbury, New Jersey. The new 3,800-square-foot laboratory will add to the company’s formulation, development, and GMP manufacturing services.  

Source: Experic 

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Colorcon To Acquire Airnov Healthcare Packaging 
Colorcon, a Harleysville, Pennsylvania-based developer of film-coating systems and specialty excipients, has agreed to acquire Airnov Healthcare Packaging, a provider of controlled atmospheric packaging, from Arsenal Capital Partners, a private equity firm.  

Airnov provides controlled atmosphere packaging to protect products from moisture and oxygen. Its products include customizable, drop-in products (canisters and packets), integrated desiccant systems, and specially designed plastic bottles containing oxygen-barrier materials. The company has manufacturing facilities in the US, France, China, and India and employs around 700 people.  

The transaction, is subject to French Works Council review and regulatory approvals, is expected to close in the first quarter of 2023. 

Source: Colorcon 

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Packaging 

Stevanato, Transcojet Partner in Prefillable Syringes 
Stevanato Group, a Piombino Besa, Italy-based provider of drug-containment, drug-delivery and diagnostic products and services, has entered into a collaboration with Transcoject, a medical device and pharma packaging company for technology under which Stevanato Group will be able to add cyclic olefin polymer (COP) and cyclic olefin copolymer (COC) prefillable syringes to its existing portfolio. 

COP and COC prefillable syringes may be used in a wide range of applications, including sensitive biologics, mRNA vaccines, and hyaluronic acid-based drugs. The technology is intended to enable a broad range of format options from 0.5 mL to 200 mL. Stevanato expects the technology to be ready in 2025 with a first validated product for Luer Lock prefillable syringe. In the interim, Transcoject will support customers by providing sampling, and the companies also intend to utilize their current capacity to meet demand. A staked-needle prefillable syringe version is expected to be launched in the following years. (as reported on January 23, 2023).  

Source: Stevanato Group