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| Humanigen Expands Partnership with Catalent Biologics to Manufacture Investigational Covid-19 Therapy |
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| As part of the partnership, Catalent will provide complete development, manufacturing, and commercialization services for Humanigen’s proprietary Humaneered® anti-human-GM-CSF monoclonal antibody, lenzilumab, a therapeutic candidate undergoing clinical trials in Covid-19 patients with a severe respiratory infection. To date, Catalent Biologics has provided early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its facility in Madison, Wisconsin, to support ongoing clinical trials. |
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| The partnership will leverage Catalent’s OneBio® integrated suite, a single solution for development, manufacturing and clinical supply distribution that accelerates timelines through parallel processing and improved planning. |
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| Catalent Enters into Strategic Partnership with Editas Medicine to Support Gene Editing Medicine Pipeline |
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| Catalent and Editas enter into a strategic partnership to support Editas’ CRISPR-based medicines pipeline. Catalent will provide integrated services from critical raw materials and viral vectors to clinical trial supply services.
“Catalent is proud to collaborate with Editas in its efforts to bring new targeted and durable CRISPR-based medicines to patients,” said Julien Meissonnier, Catalent’s Chief Scientific Officer. “Together, we have established a unique, integrated model enabling access to Catalent’s advanced cell and gene therapy technologies and clinical supply services.” |
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| Catalent Biologics to Invest $30 Million to Create European Clinical Manufacturing Center of Excellence in Limoges, France
Catalent Biologics announced that it will invest $30 million at its clinical phase facility in Limoges, France, to create a European center of excellence for formulation development and drug product fill-finish services. The company will update laboratories and install a high-speed flexible line capable of filling vials, syringes, or cartridges to supplement its global network of clinical drug substance. |
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| Catalent is Proud to Support Many High-Profile Covid-19 Programs
We are working with over 50 customers on Covid-19-related antivirals, vaccines, diagnostics and treatments. Find out more. |
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| Catalent Expands Beauty and Plant-Based Consumer Health Softgel Capabilities at its Facilities in Canada and Brazil
The expansion includes new softgel encapsulation lines dedicated to Catalent’s proprietary Vegicaps® plant-based capsule and CosmoPod® twist-off capsule technologies. The increased capacity will enable Catalent to support its customers in both North and Latin America to develop products for consumers seeking all-natural and plant-based vitamins, minerals and supplements, using its Vegicaps capsule; and those looking for innovative, easy-to-use, unit-dose beauty care products, through its CosmoPod technology. |
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| Catalent Completes Purchase of Clinical Packaging Facility in Shiga, Japan
Operating in partnership with the company’s existing Japanese clinical supply facility located in Kakegawa, the new 60,000-square-foot facility will provide customers with flexible clinical supply solutions, serving both local customers, and global biotech and pharmaceutical companies. |
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| Wetteny Joseph Recently Featured in Profile Magazine
Wetteny Joseph, Senior Vice President and Chief Financial Officer, Catalent, and new member of the Executive Leadership Council, was recently interviewed in Profile magazine, to discuss his priority to advocate for the next generation of diverse leaders. |
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| Join Our Experts at Live Virtual Events to Hear the Latest on Covid-19 and Technology Development Programs |
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| 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. |
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| World Orphan Drug Congress | August 24 - 26 | Virtual Conference
On Monday, 24 August, Thomas VanCott, Ph.D., Chief Technology Strategy Officer, Catalent Cell & Gene Therapy, will present “Creating Commercial-ready & Scalable Solutions for Gene Therapy Development & Manufacturing”. The next day, Cornell Stamoran, Ph.D., Vice President of Corporate Strategy, Catalent will deliver his presentation, titled “Preparing for Success: Early Development Considerations for Orphan Drug Commercialization”. |
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| BioProcessing Summit 2020 USA | August 24 - 28 | Virtual Conference
GPEx® cell line development technology generates highly stable, high titer production cell lines. Recently, GPEx technology and a glutamine synthase knock-out CHO cell line were combined in a unique way to create GPEx Boost. Greg Bleck, Ph.D., Global Head of R&D, Catalent Biologics, will present “GPEx® Boost: A Novel Approach for High-Expressing CHO Cell Line Engineering” and explain how the new technology results in higher specific productivities, higher titers, improved consistency, and improved cell growth characteristics as compared to GPEx for most protein products. |
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| CTS Forum | August 25 - 26 | Virtual Conference
On Monday, 24 August, Thomas VanCott, Ph.D., Chief Technology Strategy Officer, Catalent Cell & Gene Therapy, will present “Creating Commercial-ready & Scalable Solutions for Gene Therapy Development & Manufacturing”. The next day, Cornell Stamoran, Ph.D., Vice President of Corporate Strategy, Catalent will deliver his presentation, titled “Preparing for Success: Early Development Considerations for Orphan Drug Commercialization”. |
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| A Catalyst in Drug Development | | Ariana Low, Ph.D Product Development, Principal Formulations Scientist, Schorndorf, Germany |
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| Dr. Ariana Low, who is based at Catalent’s Schorndorf, Germany facility, specializes in formulation development of solid oral dosage forms. She helps bring molecules from Phase 1 to scale up and production by applying development tools employing Quality-by-Design principles from the ICH guidelines as part of the quality risk management system. Discover what drives her passion for formulation development, excipient optimization and quality management. Access her published works and additional content to help in your formulation development. |
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| Biologics
Whitepaper: “Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness Using “Manufacturing by Design” Methodology” - Download this whitepaper to learn more about the challenges associated with T-cell manufacturing, and the ways Catalent’s Manufacturing by Design (MbD) methodology can help some of these challenges and prepare for the commercialization of allogeneic cell therapies. 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? Join Dr. Thomas VanCott and other industry experts discuss manufacturing, viral vectors, to consider the most promising approaches coming to the clinic. Webinar: Clinical Readiness – Practical and Innovative Solutions for AAV Development and Manufacturing - What are the current challenges and future promises of adeno-associated virus (AAV), lentivirus, and lipid nanoparticles in gene therapies? Learn about specific case studies for neuromuscular degenerative indications, AAV technology and manufacturing, strategies for navigating the current regulatory environments in the U.S. and Europe, and much more in this on-demand webinar. Podcast: “Catalent Cell & Gene Therapy, the Journey” - In a little over a year, Catalent has expanded into the cell and gene therapy space through acquisitions. In this podcast Colleen Floreck, Senior Director, Strategy & Marketing, Cell & Gene Therapy, discusses Catalent’s journey into this exciting and growing space. |
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| Clinical Supply Services
Article: “Accelerating Timelines by Planning for Clinical Supplies in Advance” - Learn about the importance of involving a clinical supply expert while the investigational medicine is still in early development, and strategies to maintain quality and integrity while accelerating study timelines. eBook: “Important Considerations in the Packaging of Clinical Supplies” - Learn how the use of pre-filled syringes for drug delivery can meet current challenges in the biologics market, the importance of implementing a strong blinding strategy to limit bias, and the benefits of using blister packaging to ensure proper study execution. Article: “Airplane Blues” - Ricci Whitlow, President of Clinical Supply Services at Catalent, was featured in the June edition of The Medicine Maker, where she outlined the action taken by Catalent to respond to the evolving impact of Covid-19, and the importance of having a plan B, and even a plan C at the ready, to help its customers overcome unforeseen challenges that could impact clinical studies. |
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| Oral Drug Delivery
Webinar: “Bioavailability Enhancement – Industry Insights, Key Challenges & Advanced Development Solutions” - In a recent industry survey seeking to discover the challenges in developing oral dosage forms, respondents shared their top motivations and hurdles when selecting bioavailability enhancement technologies. In this webinar experts present the exclusive survey findings and introduce innovative scalable drug delivery technologies proven to address the industry’s growing need for improving solubility and enhancing bioavailability. Article: “ The Many Advantages of Repurposing Existing Drugs” - Repurposing existing drugs can be attractive as the process is often less risky, more cost effective and can be undertaken in less time. This article, published in European Pharmaceutical Review, discusses the logic behind drug repurposing and the approaches that are currently being explored. eBook: “Spray Drying for Bioavailability Enhancement” - This eBook explores the factors to consider when determining when spray drying is the right technology for bioavailability enhancement. Experts provide key insights about the optimization of process parameters and what could go wrong if not executed correctly. Additionally, considerations for when selecting an outsourcing partner are shared. Webinar: “Patient-Focused Drug Design: Through the Lens of Real-World Case Studies, Clinical Evidence and Advanced Delivery Solutions” - Watch this webinar to discover the current state of patient-focused dose design through clinical evidence, real-world case studies and patient preference-driven drug design solutions that can help develop better treatments and successful real-world outcomes. |
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| Earlier this year, Catalent was certified as a 2020 Top Employer in the United States. Organizations certified as top employers dedicate themselves to providing the very best working environment for employees through their progressive ‘people-first’ HR practices. To learn more about this recognition, click here.
Learn more about careers at Catalent, visit www.catalent.com/careers. |
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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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| 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 sales@catalent.com, 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. |
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