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Catalent in the Spotlight |
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Alessandro Maselli Officially Takes up the Mantle as Catalent President and CEO |
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Back in January, Catalent announced that Alessandro Maselli, then President and Chief Operating Officer, as the company’s next President and Chief Executive Officer. Maselli officially took on his new role as President and CEO, in addition to joining the company’s board of directors on July 1. Meanwhile, John Chiminski transitioned to the role of Executive Chair of the Board. |
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“I’m energized by Catalent’s strong momentum, and I look forward to continuing the record of performance and growth that John established for Catalent, making it the development and manufacturing partner of choice across our customers’ diverse pipelines and product portfolios,” added Alessandro Maselli. | Read More |
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Catalent Announces New Operating Structure |
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Following Alessandro Maselli’s takeover as Catalent’s President and CEO, the company announced changes to its operating structure and executive leadership team that went into effect July 1. This new organizational structure includes a shift from four reporting segments to two, each representing roughly half of the total company revenue. According to Alessandro Maselli, Catalent’s President and Chief Executive Officer since July 1, the segment changes reflect evolving customer and industry trends and position the company to deliver its next level of growth and achievement. |
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Drug Development & Delivery: SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product |
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Catalent: A Multi-Layered Approach to Minimizing Supply Risks |
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This annual, exclusive Drug Development & Delivery report describes how drug sponsors and CDMOs are collaborating in the early phases of the drug development process. Catalent’s Elliott Berger, Chief Marketing Officer, shares his thoughts about the critical support outsourcing partners |
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provide to meet funding and regulatory milestones while accelerating customers’ programs towards manufacturing scale-up for launch. “New modalities make up an expanding part of the pipeline, and these have complex development, process, and manufacturing requirements,” he says. |
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Latest News | The ‘Better Biotech’ webpage is now live! |
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Visit the new space dedicated to small and emerging pharma, with advice, strategies, and solutions designed for the specific needs of innovators. Leverage the experience gathered working with hundreds of small companies and learn how Catalent can help accelerate, simplify and de-risk the achievement of critical milestones. |
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Catalent Expands Primary Packaging Capabilities at its Clinical Supply Facility in Shiga, Japan |
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Catalent has expanded its primary packaging capabilities at its clinical supply facility in Shiga, Japan, through the installation of a high-speed blister packaging line to complement its existing automated bottling line. The 6,000-square-meter Shiga site opened in October 2021 to support customers locally and globally, providing flexible clinical supply solutions, including Catalent’s FastChain® demand-led supply, white-glove handling and logistics. |
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Catalent Supports US Launch of Phathom Pharmaceuticals’ New Products Following Regulatory Approval |
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Catalent welcomed the U.S. Food and Drug Administration’s (FDA’s) regulatory approval of Phathom Pharmaceuticals’s TRIPLE PAK™ (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA™ DUAL PAK™ (vonoprazan tablets, amoxicillin capsules), for the treatment of helicobacter pylori (H. pylori) infection in adults. |
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These new treatment options contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years. | Read More |
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ISR Signs Development Agreements with Catalent to Scale-up its Spray-dried Nasal Vaccine Powder Formulation for Phase 3 |
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ISR, an innovation-driven drug development company in the field of immunotherapy, has signed agreements with Catalent to facilitate the development of its spray-dried, SARS-CoV-2, dry powder, nasal vaccine, in readiness for its phase 3 clinical campaign. Catalent will scale up production of the spray-dried powder and provide analytical support from its Chelsea, Massachusetts, facility, which has extensive spray drying infrastructure and expertise necessary to meet clinical trial and commercial-scale volumes.
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“ISR’s decades of experience in immunology, coupled with Catalent’s expertise in spray drying, and scaling up multiple programs will support ISR as they progress toward commercializing this nasally-inhaled vaccine,” said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “We are delighted to be partnering with ISR on this important product” | Read More |
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Pharmaceutical Technology: Focusing on the Patient in Drug Development |
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For their Drug Solutions podcast, Pharmaceutical Technology interviewed a panel of experts for their views on drug dosage form trends that have had an impact on the bio/pharma industry in recent years. Cornell Stamoran, Ph.D., Vice President of Strategy and co-chair of the Catalent Applied Drug Delivery Institute, shares his thoughts about incorporating patient-focused thinking into drug product design and its benefits to patients. |
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Tablets & Capsules: Boosting Bioavailability: Micronization can Increase Oral Uptake and Improve Solubility |
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Drug Delivery often offers poor oral bioavailability, and developing more bioavailable formulations remains a challenge to scientists creating new oral dosage forms. As poorly soluble drug molecules are increasingly prevalent in the development pipeline, innovators are turning to technologies such as micronization to improve the bioavailability and solubility of these challenging compounds. |
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Beyond that, micronization can help develop suspensions as well as other formulations such as dry powders for inhalation, and improve the content uniformity of highly potent active pharmaceutical ingredients. | Read More on Tabletscapsules.com |
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Pharmaceutical Technology: Development of Coprocessed Excipients
Coprocessed excipients are blends of different excipients subjected to physical processing that leads to modifications of their physical structures without causing any chemical changes. Adoption of coprocessed excipients has been slow, however, because even when prepared using compendial excipients, they are considered “novel” by regulators. Regulatory hurdles and higher costs present the biggest challenges suggests Dejan Lamešić, Ph.D., Head of formulation and process development, Softgel and Oral Technologies at Catalent. | Read More on Pharmtech.com |
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BioProcessonline: Radiance® Label-Free Monitoring of AAV Transfection in HEK293 Cells Using Laser Force Cytology™ As a leader in the gene therapy field, Catalent Cell and Gene Therapy strives to incorporate the most advanced analytics in its processes in order to provide high quality, innovative solutions for its customers. In this technical note, collaborative efforts are described between Catalent and LumaCyte to compare AAV production with three different transfection reagents using both LFC and a digital droplet PCR (ddPCR) based viral genome titer assay.
| Read More on Bioprocessonline.com | |
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Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs |
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A Catalyst in Drug Development |
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Nicolas Thurin, Ph.D. DIRECTOR, SCIENTIFIC COMMUNITY AND OFFICE |
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Nicolas Thurin, Ph.D., is based at Catalent’s Brussels, Belgium, facility. With more than 15 years of experience as a scientist specialized in the manufacturing of sterile injectables, he has developed and managed Catalent’s analytical product development and quality control laboratories, helping to bring many customer projects to fruition. Since 2020, as a director of the company‘s scientific community, he has taken responsibility for the management of Catalent’s scientific community and office. |
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Learn how leveraging the experience and expertise of its scientific community allows Catalent to deliver products faster, helping people live better and healthier lives. Access his published works that include presentations and posters below. |
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