| | Catalent Invests Further $230M in its
State-of-the-Art U.S. Gene Therapy Campus |
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| The latest expansion in Harmans, Maryland, will see the addition of three further commercial-scale viral vector manufacturing suites, and associated facilities to accommodate 700 new scientific, technical and operational positions over the next six years. Building upon its initial $130M investment announced in 2020, the site will boast 18 CGMP viral vector manufacturing suites by the end of 2022. Manja Boerman, Ph.D., President of Catalent Cell & Gene Therapy, commented that the facility design benefits from three years’ experience in running the company’s flagship commercial gene therapy facility. |
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| | | | | Catalent Expands Clinical Supply Network with Opening of Facility in San Diego |
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| In response to increased customer demand for integrated development, clinical packaging, and distribution solutions on the U.S. West Coast, Catalent’s new facility marks the latest expansion to its global clinical supply network, and follows the opening of a new site in Japan in October. | | Learn More | Catalent Wins INTERPHEX Award
for GPEx® Lightning Technology |
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| Chosen by the American Pharmaceutical Review, Catalent Biologics GPEx Lightning technology was recognized for Biotech Innovation. | | Read About GPEx® Lightning |
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| | | Trends in the Outsourcing of R&D Contract Pharma asked industry experts, including Catalent Chief Marketing Officer Elliott Berger, why sponsors are increasingly reliant on the on the capabilities of CDMOs and CROs to address the challenges of today’s complex therapies and evolving clinical trials landscape. | | Read the Article |
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| | | Weathering the Storm Together: Outsourcing and the Pandemic Catalent’s Elliott Berger contributes to The Medicine Maker’s two-part roundtable on the pandemic and its lasting effects on pharma and biopharma outsourcing. |
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| | | | | Single-Use Bioreactors BioPharm International’s Feliza Mirasol asks industry professionals about the benefits of large-scale bioreactors in meeting growing market demand for Biologics, especially monoclonal antibodies. Catalent’s Kevin Jose argues that small-scale single-use bioreactors offer flexibility and suggests techniques to maximize their productivity. | | Read the Article | | | Serialization and Aggregation from a Manufacturing Perspective The U.S. Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to build a more secure supply chain and limit exposure to counterfeits and otherwise harmful drugs. In BioPharm International, Catalent Biologics’ Rebecca Mullis, alongside other industry experts, shares views on how the industry has responded to the Act. | | Read the full Article on page 10 |
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| | | Containing and Enhancing Potent Particles with Micronization In Pharmaceutical Technology’s APIs, Excipients and Manufacturing eBook, Catalent’s Andy Maitland discusses the benefits of Micronization as a processing technique for highly potent API’s that is both well understood and highly scalable. | | Read the full Article on pages 30-35 | | | Considerations for DPIs and MDIs in Inhalation Drug Delivery In the same eBook, Catalent’s Carolyn Berg and Carla Vozone, Ph.D., shared their perspectives on trends and considerations for choosing and designing an inhalation drug delivery device. | | Read the full Article on pages 36-42 |
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| Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs |
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| Cell and Gene Therapy
Phacilitate – Advanced Therapies Week | Miami, Florida | January 25-28, 2021 Meet our team of experts in Booth 324 to learn more about our integrated cell & gene therapy portfolio including plasmid DNA, viral vectors, and autologous and allogeneic cell therapies.
Biologics
Strategies to Accelerate the Path to Clinic for Next-Generation Antibodies | Virtual | December 1, 2021 Next-generation antibodies, particularly antibody fragments, are more complex and present technical challenges that may result in longer CMC development timelines, delaying clinical trials and commercial launch.
In this webinar, in collaboration with HollandBio and Tosoh Bioscience, experts will discuss formulation development and purification strategies to increase throughput, reduce operating costs and potentially decrease development times.
Pharma Manufacturing Europe | Virtual | December 1 - 2, 2021 In her presentation on Dec. 2 at 10:30 a.m. (GMT) titled, “Accelerating Drug Product Tech Transfers”, Catalent Biologics’ Natasha Van Rutten, Director of Product Development, considers why in a time of rapid growth of biologics, understand your products’ characteristics and formulation are all-the-more important to aiding successful technology transfers, and lifecycle management transitions into new presentations.
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Clinical Supply Services
Outsourcing in Clinical Trials East Asia | Virtual | November 30 - December 1, 2021 Catalent experts will explore how decentralized clinical trials and direct-to-patient shipments have helped keep studies on track during the pandemic, how varying supply models can be adapted to suit a trial’s unique characteristics, and how efficient supply can be achieved despite country-to-country variations in transport and other regulations.
Outsourcing in Clinical Trials Southern California | San Diego, California | December 7 - 8, 2021 Michael McNear, Director of Operations and Site Lead at Catalent’s newly opened clinical supply site in San Diego, will present, ‘Strategies to Avoid Costly Errors When Supplying Early-Phase Studies”, including what innovators should look for in a clinical supply partner, the role of a supply manager, the relative benefits of integrated versus à la carte services.
Consumer Health
MakeUp in Los Angeles | Los Angeles, California | February 23 - 24, 2022 Meet our Catalent beauty experts in Los Angeles and explore how we can partner together to bring your next product from concept to market. Schedule a meeting with our experts today!
Natural Products Expo West 2022 | Anaheim, California | March 9 – 12, 2022 Visit Catalent’s consumer health team at Booth #4381 to find out how we can partner together to bring nutritional supplement products to life! Register today and schedule a meeting with our experts. |
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| | | A Catalyst in Drug Development |
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| Amruta Mhashilkar, Ph.D. Lead Scientist |
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| Dr. Mhashilkar is a Lead Scientist at Catalent’s St. Petersburg, Florida, facility. She specializes in lipid-based softgel formulation for immediate and extended release. Dr. Mhashilkar’s is an expert in optimizing process development and technology transfers of client-related projects. Find out what drives Dr. Mhashilkar’s passion for softgel formulation and read her published works, which include five peer-reviewed articles. |
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| | Biologics
● Infocard: "Drug Product Manufacturing – Europe" - Catalent Biologics’ drug product operations in Europe can formulate, and fill/finish sterile products into vials, syringes, or cartridge injectable formats for both clinical and commercial supply.
● Article: “Development Challenges for Complex Protein Biologics” – Single-agent therapies may not always be successful in treating complex diseases for which drug resistance is a problem, such as cancer. A combination drug therapy consisting of molecules that modulate multiple targets may be needed to achieve the best possible outcome. The ability to use a single product versus multiple medications greatly simplifies the treatment process, theoretically streamlines manufacturing and potentially improves the patient experience. Pharmaceutical Technology sat down with Dr. Gregory Bleck, Vice President of Research and Development at Catalent Biologics, to discuss factors that drive the emergence of complex, protein-based biologics, areas in which these molecules are experiencing the fastest growth, and challenges in their development and advancement to the clinic.
● Webinar: “After the Pandemic, Antibody R&D Remains Key” – Learn more about the future of antibody research and development, and the ways companies are working together to bring about change. |
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| | | | | | | | Biologics Development and Manufacturing - 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 Therapies - In this 360° virtual tour, explore Catalent’s Harmans/BWI-1 clinical through commercial manufacturing facility for gene therapies. The state-of-the-art, FDA-licensed facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, including fill/finish, and contains central services labs, testing labs, and acts as our central warehouse and supply chain hub for Catalent Gene Therapy.
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| | | Oral Development and Manufacturing - In this 360° virtual tour, explore Strathroy, Ontario, one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries.
- Catalent’s Boston facility provides manufacturing and development services for inhaled powders. The site features a top-tier vendor set for capsule filling and blister packaging lines as well as spray dryers up to PSD-7 scale, the largest size for GMP pharmaceutical use in North America. With expertise in commercial launch and scale-up, the Boston site is a center-of-excellence for tech transfer projects.
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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 across Europe.
Visit www.catalent.com/careers for more information. |
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Every brand 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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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. © 2021, Catalent Pharma Solutions, Inc. 14 Schoolhouse Road, Somerset, NJ 08873. All rights reserved. |
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