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.

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.

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“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.”

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.

Biologics

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• 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.

Clinical Supply Services

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• 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.

Oral Drug Delivery

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• 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.

Consumer Health

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• eBook: “Active Aging - Opportunities to Support Health-Minded Consumers with Improved Nutritional Supplements” - Learn about the move to focus on ‘health’ rather than ‘years’, and gain nutritional insights that can help support being active across a wide range of activities.
• Infographic: “Innovation in OTC Products – A Survey Report on Why It Matters and How to Achieve It ” - Catalent and FiercePharma conducted a survey which generated responses from the OTC industry. Download this infographic to gain expert insight on trends uncovered by the survey.
• Webinar: “The Rise of Beauty Nutrition” - The conventional beauty industry is focused on aesthetics, while the nutritional industry focuses on wellbeing. As these massive markets overlap, there is an opportunity for a broader range of solutions, products, and technologies to meet consumer expectations and advantages of combining these two perspectives.

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.

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Learn more about careers at Catalent, visit www.catalent.com/careers.