The latest from CDMOs, CMOs, and suppliers featuring Catalent, Veranova, Cytiva, Archimica, and Vetter.  

General 
* Catalent Delays Quarterly Results Over Previously Disclosed Operating Issues
Chemicals/Chemical API Manufacturing 
* Veranova Names New CEO
* PI Healthsciences Acquires Archimica
Biologics Manufacturing 
* Cytiva, Life Sciences Business of Pall Complete Integration 
Formulation Development/Drug Product Manufacturing 
* Vetter Provides Update on Clinical Mfg Site in Austria 

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General 

Catalent Delays Quarterly Results Over Previously Disclosed Operating Issues   
Catalent has announced that it will be delaying the release of its fiscal third quarter, results, previously scheduled for May 9, 2023. The company now expects to file its quarterly report on May 15, 2023. Last month (April 2023),  the company provided a business update, which stated that the company expected that productivity issues and higher-than-expected costs experienced at three of its drug-product and drug-substance manufacturing facilities in Bloomington, Indiana, and Brussels, Belgium would materially and adversely impact the company’s financial results for the fiscal third quarter and its outlook for the remainder of the 2023 fiscal year.  

When combining the operational and productivity issues, the prior forecasting challenges, and, less significantly, the potential non-cash adjustments, the company says it expects to significantly reduce its guidance for its fiscal 2023 net revenue and adjusted EBITDA (earnings before income, taxes, depreciation and amortization) by more than $400 million each. In addition, the company expects that its income statement and balance sheet will reflect a goodwill impairment in its consumer health business of more than $200 million, primarily related to its $1-billion acquisition of Bettera Wellness in October 2021.  

Source: Catalent 

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Chemicals/Chemical API Manufacturing 

Veranova Names New CEO 
Veranova (formerly known as Johnson Matthey Health) has named Mike Riley, formerly President of Catalent’s Biotherapeutics Business Unit, as the company’s CEO, effective May 8, 2023. He succeeds Niek Stapel, who had led the business through its sale from Johnson Matthey to the investment firm Altaris and subsequent re-branding and launch as Veranova.  

Riley has over 25 years of professional experience, of which nearly 19 years have been spent in the CDMO/CMO sector. Most recently, he served as President of Catalent’s Biotherapeutics Business Unit, a multi-site business unit with 6,500 employees and revenues over $1 billion. 

In separate news, Veranova reported in late March (March 2023) that its subsidiary, Macfarlan Smith, a CDMO of active pharmaceutical ingredients and intermediates, has announced a proposal to close its Annan, UK, facility. The proposed closure is subject to statutory consultation requirements under UK law. 

 
Source: Veranova (CEO appointment) and Veranova (facility closure) 

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PI Healthsciences Acquires Archimica 
PI Healthsciences, a subsidiary of PT Industry, a Mumbai, India-based provider of specialty and fine chemistry products and services, has acquired Archimica, a Lodi, Italy-based CDMO of active pharmaceutical ingredients and intermediates to the innovator-drug and generic-drug industries.   

Source: Archimica 

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Biologics Manufacturing 

Cytiva, Life Sciences Business of Pall Complete Integration 
Cytiva, a provider of bioprocessing products, systems, and services, and the life sciences business of Pall Corporation, a provider of filtration, separation, and purification products, have completed their integration and are now one business under the Cytiva brand. Both companies are part of Danaher Corporation, a provider of products and services to industrial and life-sciences markets.  

In January 2023, the life sciences business of Pall separated from Pall Corporation. With the integration, Pall’s biotech portfolio is now a product family in Cytiva’s bioprocessing business. The Pall medical portfolio will remain a market brand and part of Cytiva. Pall Corporation will continue to operate as a Danaher operating company across a wide range of industrial applications. 

Source: Cytiva 

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Formulation Development/Drug Product Manufacturing 

Vetter Provides Update on Clinical Mfg Site in Austria 
Vetter, a CDMO of aseptic filling and secondary packaging, provided an update of its clinical development and manufacturing site in Rankweil, Austria.  

Purchased by Vetter in 2020, the facility received its manufacturing authorization at the end of 2021 and successfully completed its first customer fills beginning last year (2022). Vetter Development Services Austria acts as a European counterpart to the company’s clinical development and manufacturing site in Skokie, Illinois. Since its opening, the site has won 14 projects and more are in the pipeline. 

The company recently added additional equipment for aseptic production and expanded storage capacities at the Rankweil site. The use of a second autoclave and washing machine for material preparation will increase cleanroom utilization. Furthermore, the company has doubled capacity for cold storage by purchasing additional freezers. The company is also expanding its offering at the Rankweil site to include the processing of isolator, powdered substances and further options for primary packaging materials for clinical filling. 

Source: Vetter