| | Catalent in News Spotlight |
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| Drug Development & Delivery: EXECUTIVE INTERVIEW – Catalent: Developing & Delivering Billions of Doses of Drugs Every Year |
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| As he prepares to become President and Chief Executive Officer this July, Drug Development & Delivery interviewed Alessandro Maselli about what he sees as the most significant challenges the industry faces, how Catalent is responding to changes in the market, and the company’s outlook on new modalities, pharma/bioprocess 4.0, and its ambitions to solve a spectrum of development and delivery challenges for its partners. |
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| | | Latest News | Catalent Launches UpTempo Virtuoso™ AAV Platform to Reduce Gene Therapy Development Time and Accelerate Path to Clinic |
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| Catalent introduced its new, UpTempo Virtuoso™ platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The platform standardizes and streamlines many time-consuming steps in AAV manufacturing to significantly reduce the timeline from gene to clinic and enable rapid first-in-human clinical evaluation. |
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| “As one of the first CDMOs to successfully develop a suspension-based transient transfection process, and with our deep and specialized viral expertise and broad experience across more than 70 viral vector programs, we have built this new process with the goal of providing our customers with a reliable, reproducible, and scalable path to clinic,” said Manja Boerman, Ph.D., President, Cell & Gene Therapy at Catalent. |
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| | | Catalent Invests $175 Million to Expand Manufacturing Capabilities and Capacity at Winchester, Kentucky |
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| With an aim to expand its flagship U.S. manufacturing facility for large-scale oral dose forms in Winchester, Kentucky, Catalent announced that it has commenced a $175 million project to add 107,000 square feet to the site’s manufacturing footprint. The expansion, which is expected to be complete in January of 2024, |
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| will broaden the site’s highly potent material handling capabilities and containment facilities, provide additional laboratory space, and add further capacity for existing turnkey operations including dual fill encapsulation, pan coating, and a variety of packaging and analytical services. Opened in 1992, Catalent’s Winchester facility has evolved into one of the industry’s premier sites for complex oral drug formulation and manufacturing where Catalent scientists are helping to develop treatments and therapies that are tackling some of the biggest medical challenges today. Learn more about expert scientist Christin Hollis, Ph.D., and her role at Catalent’s Winchester facility in ‘A Catalyst in Drug Development’ section below. |
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| | | Catalent and MigVax Sign Agreement to Develop an Orally Disintegrating Freeze-Dried Tablet Vaccine Against COVID-19 |
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| Catalent announced that they have signed a development agreement to leverage Catalent’s proprietary Zydis® Bio orally disintegrating tablet (ODT) technology for delivering the MigVax-101 vaccine. MigVax’s lead oral vaccine program, MigVax-101, has shown positive results in preclinical tests. As an oral formulation, |
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| MigVax-101 could offer significant potential advantages in low-and middle-income countries over today’s first-generation injected vaccines, including ease of administration, transport and storage, the potential to tackle future variants, and applicability to a broader population. “We are excited to collaborate with Catalent to simplify the transportation, storage and administration of our MigVax oral Covid-19 vaccine,” commented Mr. Ran Amir, MigVax’s CEO. |
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| | | | | Nutraceutical Business Review: NBR in conversation with Catalent
In this exclusive video interview, NBR talks to Catalent's VP of Global Marketing & Strategy for Consumer Health, Dan Peizer, about the importance and relevance of gummies in today's nutraceutical sector. When discussing whether the sector has plateaued, Peizer has some interesting takes on the subject. | | Read More on Nutraceutical Business Review |
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| | | Pharmaceutical Technology: Inhalation Formulation Development: Predicting API Behavior Inhaled drug formulation involves the consideration of multiple factors, including the properties of the active pharmaceutical ingredient, the needs of the target patient population, delivery requirements, and the choice of device. Predicting the performance of a specific API is, consequently, quite challenging. While some computational approaches can help, physical experiments provide the greatest insights. | | 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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| Biologics
BIO International Convention 2022 | San Diego | June 13-16, 2022
Stop by booth 1227 to meet the Catalent team and join our seasoned experts for speaking sessions and panel discussions throughout the BIO International Convention in San Diego.
Schedule a Meeting
CASSS Bioassays 2022 | Gaithersburg, Maryland | July 19-21, 2022
Meet Catalent’s Biologics experts onsite to learn more about current perspectives, strategies and technologies used for bioassays. Schedule a Meeting
Clinical Supply Services
BSMA Annual Conference 2022 | Foster City, Calif. | June 22-23, 2022 Join Catalent’s Nicole Gray, Director, Strategic Supply Solutions, who will discuss how to ‘Successfully Implement Direct-To-Patients Clinical Studies’ and Ann McMahon, General Manager, Commercial & Integrated Development Operations at Catalent, who will be sharing her thoughts on ‘Transitioning From Clinical To Commercial: Ensuring Successful Product Launch’ in a panel discussion. Schedule a Meeting
DIA China 2022 | Suzhou, China | July 21-24, 2022 Meet Catalent’s experts at booth E11 to learn more about the trends of globalization and localization affecting drug development and innovation. Schedule a Meeting
Oral & Specialty Delivery
Utilizing Phase Appropriate CMC Strategies Throughout Clinical Development | June 28, 2022 |11a.m EDT/ 4p.m BST/ 5p.m CET A CMC strategy can significantly impact the time and costs required to move a drug candidate through all phases of clinical development. For both the regulatory and manufacturing aspects of drug development, phase-appropriate strategies can help focus available resources to efficiently achieve goals and progress the project to the next milestone. Join this webcast designed for emerging biopharma, consultants and early-stage drug developers and learn how to accelerate and de-risk drug development programs and give your molecule the best chance for success!
Unraveling the Complexities in Nasal Vaccine Development, Manufacturing and Device Selection| June 29, 2022 |11a.m EDT / 4p.m BST /5p.m CET In recent years, there has been increased interest in the intranasal delivery route, with numerous studies demonstrating promising results in improving the delivery of therapeutic vaccines. In this webinar, experts will share insights into developing intranasal vaccine analytical tools and how to improve the speed and quality of critical batch release and characterization assays. A detailed discussion on the challenges and opportunities of intranasal approaches will include the importance of device selection in determining product performance. |
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| A Catalyst in Drug Development |
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| Christin Hollis, Ph.D. Associate Director, Product Development
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| Dr. Hollis specializes in large-scale/late-stage oral dosage form drug development at Catalent’s Winchester, Kentucky, facility. She collaborates with clients and internal technical service teams to develop robust processes by implementing Quality by Design (QbD) approaches that are optimized and scalable for commercial launch and ongoing supply. Dr. Hollis received a bachelor’s degree in chemical engineering, and a doctorate in pharmaceutical science, both from the University of Kentucky, Lexington. Her published works include six peer-reviewed articles, a patent, and several executive summaries and case studies. |
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Clinical Supply Services
EBook: “Clinical Trial Modernization-Optimizing the Supply of Decentralized Studies” - The rise of decentralized trials (DCTs) in recent years illustrates a growing trend for more patient-centric clinical studies. As a result, the need for flexibility in supply has led to an increase in sponsors’ requests for more specialized services by clinical supply providers, including demand-led supply and direct-to-patient distribution. What are some key supply considerations that sponsors need to keep in mind when planning a DCT? What should they look out for when choosing a supply partner for these types of studies? |
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| Oral Drug Delivery
Infographic: “ Fundamentals of Spray Drying Process Development” - Spray drying is a well-established and versatile processing technology that offers several advantages in drug formulation and manufacturing. Download this infographic for some quick insights into the spray drying process, and learn how a robust scale-up methodology can help progress spray dry formulations from pilot scale to commercial-scale production.
Webinar: “ Key Challenges and Opportunities in the Process Scale-Up of Oral Solid Dosage Forms” - Choosing the right manufacturing process for oral solid dosage (OSD) forms can be a challenging task as there are several manufacturing technologies and approaches to consider. Evaluation of the different approaches and manufacturing technologies is also key to discovering potential opportunities to accelerate the scale-up process. In this webinar, industrial and academic experts will share insights into faster drug product manufacturing in a large-scale setting, discuss emerging trends in OSD manufacturing and share strategies to ensure that quality is built into manufacturing processes.
Webinar: “ The Phase 1 Trial Setup Toolbox” - Initiating first-in-human studies after an Investigational New Drug (IND) clearance — how are the experts doing it in 2022? This Endpoints Studio panel of drug developers will discuss innovative trial designs, on-demand manufacturing, communication between clinical partners, prepping a strong regulatory submission, and enabling faster decision making in your phase 1 trial.
Executive Summary: “ Effective Scale-Up and Technology Transfer Strategies for Spray Dried Products” - Spray drying is a well-established technology used to manufacture amorphous solid dispersions, which improve the bioavailability of poorly soluble drug compounds. The technology can be scaled from milligram to metric ton volumes, enabling the production of spray-dried intermediates that can be readily formulated into tablets, capsules, and other oral solid dosage forms. Download this executive summary article to learn about best practices and strategies to mitigate risks and ensure a successful tech transfer from development through to commercial-scale spray drying of pharmaceutical products. |
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| Consumer Health
Article: “The Shift to “Experiential” in the Supplement Market” - In the supplement market there are several factors that impact the consumer experience, with one of the most important being the delivery format, where there has been notable shift in how consumers want to ingest their daily dose of supplement products and make the experience more enjoyable. Learn more about the trend that is shifting the growth of the supplement market today, and will continue to do so for years to come. Fact Sheet: “ Wellness Product Library”- Catalent now offers ready-to-market formulations in trending formats such as gummy, soft chew, and lozenge. Learn more about Catalent’s wellness collection Video: “ CosmoPod® Duo: A Dual-Chamber Capsule for Beauty!” - Catalent’s CosmoPod® Duo offers an innovative delivery form that provides the ability to combine two active ingredients into one dual-chamber softgel with all of the benefits of our CosmoPod® Technology. Infographic: “Why Choose Catalent for Consumer Health Innovation”- In the consumer health industry, there are several factors that shape the success of any innovation. In this infographic, learn more about how Catalent expertise and technologies can differentiate your brands and help to launch your next product. |
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| | | Biologics Development and Manufacturing
In this 360° Virtual Tour at Catalent’s facility in Bloomington, Indiana, explore our North American Center of Excellence for early-phase clinical biologics formulation development and drug product fill/finish. Explore the world-class late-stage and commercial manufacturing for vial fill/finish and secondary packaging of biologics and sterile products in this 360° virtual tour of Catalent’s facility in Anagni, Italy.
Cell and Gene Therapy
In this 360° Virtual Tour, explore Catalent’s Houston clinical development and manufacturing facility for cell therapies. The state-of-the-art facility, at approximately 32,000 sq. ft., houses eight CGMP clean rooms, two tech transfer labs, and fill/finish services. The site has broad cell type expertise across immunotherapies and stem cells for both autologous and allogeneic cell therapy programs. Catalent has a network of cell therapy clinical and commercial manufacturing facilities in the U.S. and Europe. Discover its capabilities for the development and manufacturing of allogeneic and autologous immuno- and stem-cell therapies. Learn about the company’s expertise in both early and late-stage manufacturing as you get a glimpse inside our cell therapy facility in Gosselies, Belgium.
Oral Development and Manufacturing
In this 360° Virtual Tour, explore Catalent’s center of excellence for late phase and commercial-scale spray dry manufacturing in Haverhill, U.K. The site offers industry-leading expertise in the scale-up and commercialization of spray-dried dispersions as well as a broad range of integrated analytical support services. The Boston, Massachusetts facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site has over 20 years of experience in inhalable dry powders and Catalent is the only CDMO globally to offer end-to-end spray drying, powder encapsulation, and blister packaging capabilities from development through clinical and commercial manufacturing. |
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| We are the Catalyst for your success. Join us! |
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| Catalent ignites the development of their future leaders by continuously investing in their employees and creating an innovative environment to advance their potential. We are growing rapidly across sites in Bloomington, Indiana; Madison, Wisconsin; Harmans, Maryland; Kansas City, Missouri; and elsewhere.
Visit www.catalent.com/careers for more information. |
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Every molecule has a challenge. We have a solution.
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| | | or call +1 877 891 9609 to speak with one of our experts today! |
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