| | | | | | Catalent is Helping to Combat the Global Pandemic of Covid-19 | |
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| | | | | Catalent is actively partnering with several customers on early-stage and feasibility projects for potential vaccines or treatments related to COVID-19 and exploring where we can help with other possible projects across our biologics, cell & gene therapy, oral technologies and analytical capabilities. We are treating these projects with utmost urgency, so that we may apply our expertise for the benefit of patients and their loved ones in this tragic situation. Contact us to find out more. |
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| | | | | | | Image: Centers for Disease Control and Prevention |
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| | | Catalent Responds to the Global Outbreak of COVID-19 | |
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| | | | | As a global development and manufacturing partner that supplies medicines, clinical trial materials, and health products to millions of patients and consumers, we are taking decisive action to minimize the impact of the COVID-19 pandemic on our employees, partners, customers and their patients.
To help ensure the safety of our employees and partners, and to protect supply to patients we have taken extensive actions, which are in line with guidelines issued by the U.S. Centers for Disease Control and Prevention, the World Health Organization and local authorities where we operate. These safety measures include re-emphasizing good hygiene practices to all, restricting visitor access to our sites, limiting employees to only business-critical travel, and, wherever possible, employing remote-working strategies.
As we navigate the COVID-19 pandemic, Catalent will continue to put the Patient First, and will do everything possible to keep our people safe and healthy, and to strive to meet the needs and expectations of our customers.
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| | | | | | | | First FDA Approval of Generic HFA Inhaler | |
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| | | | | Last month, Catalent and Perrigo welcomed the news that the U.S. Food and Drug Administration (FDA) had approved the first generic hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI). The approval marked a significant technical achievement, as it was the first generic MDI to be approved by the FDA since 1996. This new commercial offering adds to Catalent’s existing development and manufacturing capabilities across all common inhalation dosage forms. Perrigo’s launch of Albuterol Sulfate Inhalation Aerosol marks Catalent’s entry into commercial-scale MDI manufacturing, adding new capabilities to Catalent’s Research Triangle Park, North Carolina, facility, and bolstering its respiratory portfolio, which includes various formulation, development and manufacturing services. |
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| | | | | | | | | Due to the COVID-19 pandemic, many live events have either been postponed or cancelled. But you can stay current on all the latest solutions needed to advance your projects by visiting our website and tuning into these upcoming webinars and presentations. |
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| | | | | | | | | | | | | | | | | Catalent Partners with Biohaven on New Fast-Dissolve Migraine Treatment
Catalent welcomed the announcement by Biohaven Pharmaceutical Holding Company Ltd. that the FDA has approved its NURTEC™ ODT (rimegepant) for the acute treatment of migraine in adults. NURTEC ODT has been developed using Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water.
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| | | | | | | Catalent Announces Supplying Blueprint Medicines’ Precision Therapy AYVAKIT™ (avapritinib)
Catalent also welcomed the announcement by Blueprint Medicines Corporation that the FDA has approved AYVAKIT™ (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. |
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| | | | | | | | A Catalyst in Drug Development | |
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| | | Christopher Hepler Manager, Lab Operations, Catalent Biologics |
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| | | | | Christopher specializes in potency assay (Bioassay, ELISA) and molecular biology (PCR/qPCR and cell engineering) development and validation for product release and stability testing. He works out of Catalent’s Research Triangle Park facility in Morrisville, North Carolina. Christopher will be giving a virtual presentation during the upcoming BEBPA event where he will present “Conversion of a Potency Assay from Cell-Based ELISA to AlphaLISA: Taming a Disturbance in the Force” on March 27. Discover what drives his passion for Bio-Analytical research. Access his works that include nine peer-reviewed articles, and additional content to help you in your research development. |
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| | | | | | | | | BIOLOGICS
Article: “Gene Therapy – Unprecedented Growth and Challenges” - Philip Wills, Chief Commercial Officer, Catalent Gene Therapy gives his insight on the latest trends and growth drivers in gene therapy, and strategies to overcome manufacturing challenges.e-book: “Frontiers in Binding Assays and Bioassays” - Bioassays and binding assays are integral to biologics development and manufacturing and play a critical role in ensuring product quality, safety and efficacy. Download the e-book to get expert insight on recent advances in bioassays and binding assays and how they are evolving to meet the demands of the industry.Webinar: “The Do’s and Don’ts of Managing a Pivotal Gene Therapy Trial” - Gene therapies have been exploding in popularity, with big and small players. But what does it take to de-risk a pivotal, registration-worthy gene therapy program? Hear the experts discuss ways of bringing gene therapies to market.Article: “Investments Inject Growth in Cell and Gene Therapies” - Colleen Floreck, senior director of Marketing and Communications at Catalent’s Paragon Gene Therapy is interviewed by PharmTech.com and discusses further collaborations, validating its proactive investment strategy in its Gene Therapy business. |
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| | | | | | | | | | | ORAL DRUG DELIVERY
Webinar: “A Roadmap for Early Development to Commercial Manufacturing” - This webinar will use real-life examples to show how an integrated approach can help avoid common pitfalls in the transfer and scale-up process. Article: “Placing Patients at the Center of Drug Design” - Poor patient acceptance and adherence to medications continue to be some of the key challenges facing the healthcare and pharmaceutical industries. Learn strategies for formulation and dosage forms that developers can use to bring patient insights into the design of their drug products to potentially improve patient centricity. Video: “Catalent Zydis Fast Dissolve” - Whether you are considering an orally disintegrating tablet (ODT) to enhance pharmacokinetics through pre-gastric absorption, looking to improve patient compliance, or seeking a marketing advantage for a valued brand, Zydis® ODT technology can help enhance the value of your investment and accelerate your product’s potential. Article: “Improving Bioavailability & Solubility: Understand Your Molecule” - Catalent’s William Wei Lim Chin, PhD, Manager, Global Scientific Affairs, discusses how different approaches are critical to the success of small molecules. In this article Dr. Chin advises when successfully formulating a small molecule, the question of whether the molecule is dissolution-rate limited or solubility-limited for it to become systematically bioavailable must be addressed.
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| | | | | | | | | | | | | | | At Catalent, you will have the opportunity to thrive in a fast-paced, innovative environment where maximizing your potential isn’t just your own personal goal, it’s ours too. Our teams are rapidly growing in the greater Baltimore area, Bloomington, IN, Schorndorf, Germany and multiple other locations. Apply today! Interested in working in Gene Therapy? Click here to view our openings. |
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| | | | | | | | | | Every brand has a challenge. We have a solution. |
| | | | | | | | or call +1 877 891 9609 to speak with one of our experts today! |
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For more information call +1-866-720-3148 or in Europe 00800 88 55 6178, email us at [email protected], or visit our website www.catalent.com. And to learn more about Career opportunities across our global network, visit www.catalent.com/careers.
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Links to third party sites are provided as a convenience only. Catalent makes no representation or warranty about the technology, security or any content available at these sites. Links are not intended to imply Catalent's affiliation or endorsement or the website, its owner(s) or the content. | | © 2020, Catalent Pharma Solutions, Inc. 14 Schoolhouse Road, Somerset, NJ 08873. All rights reserved. |
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