atalent is Proud to Support Most of the Highest Profile Covid-19 Vaccine Programs
| |
| |
| Catalent is Proud to Support Many High-Profile COVID-19 Programs' |
|
|
|
|
|
|
| Moderna, Inc. and Catalent announce a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Indiana. |
|
|
|
| | |
|
|
| As part of the agreement, Catalent will provide vial filling and packaging capacity to support production of an initial 100 million doses of the vaccine candidate intended to supply the U.S. market starting in the third quarter of 2020. The companies are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses. Catalent will also provide clinical supply services from its facilities in Philadelphia, Pennsylvania including packaging and labeling, as well as storage and distribution to support Moderna’s Phase 3 study. |
|
|
|
|
|
|
| |
| Catalent Signs Agreement with AstraZeneca to Manufacture COVID-19 Vaccine Candidate |
|
|
|
|
|
|
| |
| Catalent Biologics signs agreement with AstraZeneca to manufacture its vaccine candidate. It will provide vial filling and packaging capacity at Catalent’s manufacturing facility in Anagni, Italy, and prepare for large-scale commercial supply of the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate, AZD1222. |
|
|
|
| | |
|
|
| The agreement accelerates the rapid scale-up of capacity over the coming months to support the dedicated production of AZD1222. Catalent will prepare the facility to enable round-the-clock manufacturing schedules and supply hundreds of millions of doses of the vaccine candidate from August 2020, and potentially through to March 2022 should the product be approved by regulatory agencies. |
|
|
|
|
|
|
| |
| |
| Catalent Partners with ViralClear Pharmaceuticals on Potential Treatment for COVID-19
Catalent has signed an agreement with ViralClear Pharmaceuticals, Inc. (ViralClear), a subsidiary of BioSig Technologies, to work on the development of a potential treatment for adults with advanced Coronavirus Disease 2019 (COVID-19). Under the terms of the agreement, Catalent will be developing two oral dosage forms of ViralClear’s broad-spectrum anti-viral agent, merimepodib: a solution and a solid oral dosage form. Catalent will work on the program at its St. Petersburg, Florida. |
|
|
|
|
|
|
| |
| |
| Catalent Partners with Spicona to Develop COVID-19 Vaccine Candidate using GPEx® Cell Line Development Platform
Catalent has signed an agreement with Spicona, Inc. to develop a virus-like protein (VLP)-based vaccine against COVID-19. Catalent will use its proprietary GPEx® cell line development technology to develop a cell line expressing the recombinant VLP at its facility in Madison, Wisconsin. |
|
|
|
|
|
|
| |
| | | Catalent Leaders Listed in The Medicine Maker 2020 Power List
John Chiminski, Catalent’s Chair and Chief Executive Officer, and Mike Grippo, Senior Vice President, Strategy & Corporate Development, feature in The Medicine Maker’s annual 2020 Power List of the industry’s top 20 influential leaders. |
|
|
|
|
|
|
| |
| Join Our Experts at Virtual Live Events and hear the Latest on Covid-19 and Technology Developments |
| | Catalent’s participation at live events has either been postponed or cancelled due to the COVID-19 pandemic. Stay current on all the latest solutions needed to advance your projects with our webinars and virtual events.
Controlled Release Society | June 29 – July 2 | Virtual Conference
Catalent’s Lisa Caralli, Director, Science & Technology will give a virtual presentation on “Data Driven Formulation Approaches for Oral Small Molecule Drugs” on June 30. The presentation will examine the role of physicochemical and biopharmaceutical data and discusses why solubility is only part of the equation when addressing a molecule’s bioavailability and potential success as an oral drug candidate.
Direct-to-Patient and Virtual Clinical Trials – A Digital Experience | July 9 | Virtual Conference
Join us on July 9 and hear Catalent’s Nicole Gray – Director, Strategic Supply Solutions present “Direct-to-Patient and Virtual Clinical Trials”. This session will explore results from a recent industry survey on sponsors’ perspective on DTP, including their current level of awareness and understanding of any factors that may influence their ability to conduct a decentralized trial.
One Nucleus ON Helix Digital | July 14 | Virtual Conference
Ian A. Barker, Ph.D. CChem MRSC, Director, Pharmaceutical Development at Catalent’s facility in Nottingham, U.K., will present, “Reducing Risks in Early Drug Development: From Drug Candidate to Phase 1 Clinical Testing”. He will discuss the key testing strategies that can help determine the potential of a molecule, as well as the type of data collection needed in order to support molecule developability assessment and physiologically based pharmacokinetic (PBPK)/ drug metabolism and pharmacokinetic (DMPK) evaluations. |
|
|
|
|
|
|
| A Catalyst in Drug Development |
|
|
|
|
|
|
| Dejan Lamesic, MPharm Product Development Scientific Team Leader, Catalent Schorndorf |
|
|
|
|
|
|
| In his role at Catalent, Dejan specializes in the material science of excipients, specifically fillers and polymers for immediate and controlled release solid dosage forms. His strong expertise in particle engineering and compaction process includes tableting and dry granulation. Discover what drives Dejan’s passion for pharmaceutical materials science. Access his published works, including a patent and peer-reviewed articles. |
|
|
|
| | |
|
|
| |
| |
| BIOLOGICS
Webinar: “ASCO Postview: Highlights from the 2020 Virtual Conference” - Experts break down the data released during the recent American Society of Clinical Oncology (ASCO) virtual conference, as well as the implications they could have for prescribers, patients and drug makers. Executive Summary: “Radiance® Label-Free Monitoring of AAV Transfection in HEK293 Cells Using Laser Force Cytology™” - Catalent and LumaCyte experts collaborate to compare AAV production with three different transfection reagents using both LumaCyte’s Laser Force Cytology (LFC) instrument, Radiance®, and a digital droplet polymerase chain reaction (ddPCR) based viral genome titer assay. Webinar: “Cancer R&D Summit: The Outlook for Cancer Gene Therapies” - What hurdles need to be overcome before gene therapy is a major new modality in the cancer therapy arsenal? Catalent’s Thomas VanCott, Ph.D., and other industry experts discuss manufacturing, viral vectors, and consider the most promising approaches employed in new treatments coming to the clinic. Webinar: “R&D Leadership During the Pandemic” - Top R&D execs discuss how they’ve reorganized global teams, tapped new programs as a priority to fight COVID-19 and plan for the future after the pandemic has passed. View this fireside chat with Endpoints Founder John Carroll and Laurie H. Glimcher, President and CEO of the Dana-Farber Cancer Institute followed by a panel discussion from leaders at GlaxoSmithKline, Takeda, Amgen, Johnson & Johnson and Catalent’s Chair & CEO John Chiminski. |
|
|
|
| | |
|
|
| CLINICAL SUPPLY SERVICES
Article: “Finding New Efficiencies in Clinical Trial Logistics” - The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks. Eric Valentine, Vice President of Clinical Supply Services recently joined other industry experts in sharing his insights with Pharmaceutical Technology. Article: “APAC Region Distribution Considerations for Clinical Trial Supplies” - Maintaining business continuity when executing a supply chain plan is critical to a trial’s success. Catalent’s Daniel Gao and Tracey Clare address common distribution challenges encountered within APAC and discuss possible solutions a sponsor should consider and implement. Webinar: “How Protocol Design Drives Comparator Sourcing Cost, Timelines, Complexity and Risk” - Clinical trial protocol design can have a significant impact on commercial drug sourcing strategy. Learn the appropriate level of detail to include in the study protocol to help avoid common sourcing issues. |
|
|
|
| | |
|
|
| ORAL DRUG DELIVERY
Article: “Formulating for Convenience and Compliance” - In this month’s issue of Pharmaceutical Technology, Ralph Gosden, Head of Product Development at Catalent’s facility in Swindon, U.K., describes the benefits of orally disintegrating tablets (ODTs) and explains how they can improve patients’ experiences. ebook: “Elemental Impurities- Guidelines, Testing and Assessments” - Published by Pharmaceutical Technology, this eBook provides an overview of the regulatory landscape related to elemental impurities testing, discusses the challenges of implementing ICH Q3D guidelines, and describes strategies for compliance. Webinar: “How to Effectively Work with a Development Partner – From a Consultant Standpoint” – Efficient drug development requires that scientific, business and regulatory activities are integrated. Hear from industry experts on the latest tips that will help your clients avoid critical pitfalls in early drug development. Hear case studies in characterization and formulation of oral small molecule drugs presented, which can help your clients succeed. |
|
|
|
| | |
|
|
| |
| |
| 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.
We are rapidly growing in multiple locations including Bloomington, Madison, St. Petersburg & at our Gene Therapy sites in Maryland.
|
|
|
|
| | |
|
|
| |
| Every brand has a challenge. We have a solution. |
| | | | or call +1 877 891 9609 to speak with one of our experts today! |
| | |
|
|
|
|
|
| |
| |
| To unsubscribe or manage your subscriptions, please click here.
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. Catalent Pharma Solutions respects your privacy. 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 of the website, its owner(s) or the content. © 2020, Catalent Pharma Solutions, Inc. 14 Schoolhouse Road, Somerset, NJ 08873. All rights reserved. |
|
|
|
|
|
|
| |
