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Article / Jun 01, 2014

Why Dr. Hamburg Needs Her Dean’s List

Guy Villax Letter, June 2014

The quality metrics debate needs to recognize the paramount importance of quality culture over and above the mere compliance that results from meeting a quality system. What is needed is a simple reward system that identifies role models. An FDA’s Dean’s List will solve many problems: it will reward those producers that do the right thing for the patient, it will encourage innovation in pharmaceutical manufacturing, it will allow inspection resources to be applied wisely, it will make quality an effective differentiator at a time when the vast majority of manufacturing is done through outsourcing. This paper flags the responsibility of the CEO in driving the organization’s quality culture: the final safety net that assures patients only get good medicines.

 

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The CDMO’s New Jersey manufacturing site expansion will eventually cover more than 200,000 square feet. Portugal-based contract development and manufacturing organisation (CDMO) Hovione has completed an initial $100 million investment round in its East Windsor, New Jersey site. Once completed it will increase the facility’s footprint to more than 200,000 square feet and more than double its capacity for spray drying. Hovione CEO Jean-Luc Herbeaux said: “Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the US, we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.” Spray drying is an increasingly important particle engineering technology for improving drug bioavailability through the amorphous solid dispersion (ASD) that can address bioavailability or crystallisation challenges. The initial phase of Hovione’s expansion will include a 31,000-square-foot building to house two size-3 spray dryers (PSD-3) designed for ASD production. Construction at the New Jersey site is already underway and the company plans to start GMP operations in the second quarter of 2026. The initiative is part of Hovione’s long-term strategy to grow its US operations and enhance its integrated drug substance, drug product intermediate and drug product capabilities. Herbeaux said: “This investment addresses growing customer demand for US-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.” The company’s New Jersey expansion fits into its wider international growth plan that also includes capacity investments in Ireland and Portugal as it seeks to create a network of autonomous sites spanning the development and commercialisation of APIs, drug product intermediates and drug products.   Read the full article at EuropeanPharmaceuticalReview.com  

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Hovione doubles spray drying capacity with $100m US investment round

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The latest from CDMOs, CMOs, and suppliers featuring Thermo Fisher Scientific, Lonza, SK pharmteco/Lotte Biologics, Hovione, Sai Life Sciences, BioCina, Alcami, Piramal Pharma/IntoCell and Roquette. Formulation Development/Drug Product Manufacturing: Hovione Completes Initial $100-M Investment Cycle in US Operations Hovione, a CDMO of drug substances and drug products, has completed an initial $100-million investment cycle at its site in East Windsor, New Jersey, as part of a strategy to increase its US operations and enhance its integrated drug-substance, drug-product intermediate, and drug-product capabilities. Upon completion, the site will cover more than 200,000 square feet.   The initial expansion phase includes a 31,000-square-foot building that will house two size-3 spray dryers (PSD-3) designed for production of amorphous solid dispersions (ASDs). This investment more than doubles Hovione’s spray-drying capacity in the US by expanding capabilities for ASD development and commercial manufacturing. Construction is underway at the New Jersey site, with GMP operations planned to start in the second quarter of 2026.  As part of this expansion, Hovione has also acquired additional adjacent land to enable future growth at the East Windsor site. The 125,000-square-foot greenfield will support large-scale production, including continuous and batch tableting capacity, and introduce the latest pharmaceutical technologies and digital innovation with enhanced quality control and R&D capabilities.    Read the full article at DCATvci.org  

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