| | Endpoints: Carolyn Bertozzi, repeat biotech founder and launcher of a field, shares in chemistry Nobel win |
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| Carolyn R. Bertozzi, clinched one of the world’s top awards, winning the Nobel Prize in Chemistry alongside K. Barry Sharpless and Morten Meldal. Dr. Bertozzi is one of Catalent’s biologics advisory board members. She founded |
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| Redwood Biosciences, which was acquired by Catalent in 2014 and is the basis of our proprietary SMARTag® ADC bioconjugation technology.
The Royal Swedish Academy of Sciences in its press statement commented that Carolyn Bertozzi took click chemistry to a new level. To map important but elusive biomolecules on the surface of cells – glycans – she developed click reactions that work inside living organisms. Her bioorthogonal reactions take place without disrupting the normal chemistry of the cell. These reactions are now used globally to explore cells and track biological processes. Using bioorthogonal reactions, researchers have improved the targeting of cancer pharmaceuticals, which are now being tested in clinical trials. “This year’s Prize in Chemistry deals with not overcomplicating matters, instead working with what is easy and simple. Functional molecules can be built even by taking a straightforward route,” says Johan Åqvist, Chair of the Nobel Committee for Chemistry. |
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| | | Connect with Catalent experts in person at upcoming events | | Meet with experts LIVE at the Catalent booth at BIO- Europe, Supplyside West and join us for our in-booth networking receptions at CPHI Frankfurt to learn more about our latest capabilities, capacity expansions and technology enhancements to bring life-changing treatment to patients.
Schedule a meeting today! |
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| Latest News | Catalent Appoints Dr. Wai Lam Ling as Vice President, Scientific Advisory | In September, Catalent announced the appointment of Wai Lam Ling, Ph.D., as Vice President, Scientific Advisory. Dr. Ling will lead Catalent's scientific advisory team of experts helping innovators develop new therapeutics, elevate Catalent scientific leadership, and help customers select the best formulation, delivery and manufacturing processes and technologies to solve their challenges, improve their treatments and bring them to the patients.
Dr. Ling joins Catalent's scientific community with more than 25 years' experience in R&D and CMC operations across biologics and gene therapies companies including Rocket Pharmaceuticals, Merck & Co (MSD) and Schering-Plough Corp. She has led the successful development and regulatory filings of more than 20 biologics, and supported commercialization of several biologic products including cancer treatment Keytruda® (pembrolizumab). |
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| | | | | Awakn Life Sciences Signs Drug Development Agreement with Catalent for Zydis® Orally Disintegrating Tablet Technology to Conduct Feasibility Studies to Improve Differentiation of its MDMA Program |
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| Awakn Life Sciences Corp., a biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), recently announced that it has signed an agreement with Catalent that will focus on investigating a market-ready proprietary formulation |
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| and optimized delivery route for MDMA using Catalent’s proprietary Zydis® orally disintegrating tablet (ODT) technology.
The agreement will allow Awakn to conduct feasibility studies using Zydis technology for addiction, including substance and behavioral addictions, as well as other mental health disorders, including anxiety, depression, post-traumatic stress disorder (PTSD), and eating disorders. | | Learn more on awaknlifesciences.com |
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| BioPharma International: Streamlining Bulk mAb Manufacturing |
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| Christopher Kistler, Principal Scientist, Biologics Product Development, Catalent Biologics, shares insights on the challenges and limitations when manufacturing monoclonal antibodies. He points out that the data operations in mAb production can pose a challenge because information needs to come from: connected online systems, |
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| including bioreactor control systems; non-connected systems, such as laboratory information management system (LIMS) repositories; and from manual operations where data are locally recorded in the documentation. “All data needs to come together to enable real-time processing decisions across these diverse unit operations, and delays due to offline analytical testing can result in long intermediate hold times that place stress on even the most robust processes,” he states. | | Learn more on biopharminternational.com |
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| Drug Development & Delivery: Catalent Expands Singapore Clinical Supply Facility for Increased Temperature-Controlled Capabilities | Catalent recently announced a $2.2-million expansion to its clinical supply facility in Singapore. The investment will increase the site’s footprint by nearly 20% to 31,000 square feet, and allow the installation of 35 new freezers for ultra-low temperature (ULT) storage.
The expansion will also see the addition of specialized secondary packaging capabilities for ULT products, enabling the site’s services to support larger packaging campaigns, and increasing capabilities to handle biopharmaceuticals and advanced modalities, including mRNA-based vaccines, and cell and gene therapies.
| | Learn more on drug-dev.com |
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| Emballages Digest: Powder Inhalers |
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| Catalent’s Carolyn Berg, Vice President, Inhalation, shares her thoughts on the dry powder inhaler (DPI) market in the French magazine Emballages Digest. Carolyn’s comments include that the DPI market is growing, and she proposes that whilst small molecules in low doses are formulated using proven technologies such as micronization and mixing, with lactose as a carrier for aerosolization, these |
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| technologies may not work for high loads. For these applications, spray drying is increasingly used to improve the stability and efficiency of dry powders. | | Learn more on emballagedigest.fr |
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| Catalent’s SMARTag® Technology awarded runner-up at the 9th Annual World ADC Awards 2022 | Catalent’s SMARTag technology was recognized as runner-up for the Best ADC Platform Technology. |
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| The awards recognize recent successes, long-term commitment to the field and those who have gone above and beyond to ensure the continued success of their field and bring more life-changing drugs to patients. Learn more about Catalent’s award winning SMARTag platform technology that offers ADC and biologics innovators a toolkit to develop optimized ADCs and bioconjugates. |
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| | | Better Biotech with Catalent |
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| Visit the new space dedicated to small and emerging pharma, with advice, strategies, and solutions designed for the specific needs of innovators. Leverage the experience gathered working with hundreds of small companies and learn how Catalent can help accelerate, simplify and de-risk the achievement of critical milestones. Learn more |
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| Ebook: Early Drug Development Strategies for Clinical Success
Every clinical study is different, each with its own unique characteristics and requirements. The optimal time to begin planning a clinical supply strategy is while the study drug is still in the early development stage. This eBook discusses key areas to consider in order to help navigate individual study complexities and to mitigate risk. | | Learn More |
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| Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs |
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| CPHI Frankfurt 2022 | Frankfurt, Germany | November 1-3, 2022
CPHI worldwide is back LIVE in person in Frankfurt, Germany this year! Visit stand 90G20 in hall 9 zone ICSE to meet with our experts and learn more about our latest capabilities, capacity expansions and technology enhancements to bring lifechanging treatment to patients.
Join Us for Our In-Booth Networking Receptions Tuesday, November 1, 2022 | 4:30PM – 6:30PM
Wednesday, November 2, 2022 | 4:30PM – 6:30PM
Schedule a Meeting |
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| | | | | Biologics
6th Annual Gene Therapy for Rare Disorders Europe Summit| London, UK | October 25-27, 2022
Stop by our booth to meet our Catalent experts ready to discuss development and manufacturing solutions for your viral-vector-based therapies. Schedule a Meeting
EUBIO22 The European Biopharma Summit | London, UK | October 25-27, 2022 Tune in for Catalent’s expert, Wai Lam Ling, Ph.D, joined by some of the leaders in mRNA, who will discuss what factors are driving the next round of innovation in the field, at the session “Faster, better, cheaper? What’s next for mRNA?” Schedule a Meeting
Festival of Biologics | Basel, Switzerland | November 2-4, 2022 Hear Catalent Biologics’ formulation expert Jean-Francois Boe presents on, “Accelerated Biologics Development Strategies for Path to Clinic” on November 2,2022. Schedule a Meeting
New Horizons in Biologics & Bioprocessing| Stockholm, Sweden | December 15th 2022 Schedule a meeting with our Catalent experts at New Horizons in Biologics & Bioprocessing. Register now! |
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A Catalyst in Drug Development |
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| Diogo Gomes Lopes, Ph.D. Product Development, Principal Formulation Scientist |
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| Dr. Lopes is a Product Development Principal Formulation Scientist at Catalent’s Schorndorf, Germany, facility. He has a background in quality assurance, patient-centric product design, continuous manufacturing and pharmaceutical engineering. Dr. Lopes and his team focus on development of solid oral dosage forms. His expertise involves taste masking techniques using lipid coatings. Discover what drives |
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| his passion for pharmaceutical development from pediatric to geriatric formulation. Access his works (here) that include ten peer-reviewed articles and scientific posters, to help you develop and design high quality patient centric drug products. |
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Biologics Factsheet: “SMARTag® ADC Technology” Learn more about Catalent’s award winning SMARTag platform technology that offers ADC and biologics innovators a toolkit to develop optimized ADCs and bioconjugates.
Webinar: “Scale-up Strategies for Late-stage Cell Therapies” The number of autologous cell therapy products commercially approved or approaching launch is growing, with allogeneic therapies very close behind. CDMOs need to ensure they are designing innovative processes and flexible facilities that can accommodate both autologous and allogeneic cell therapy products for small and large patient populations. In this webinar, we explore the considerations that need to be taken during development to ensure manufacturing processes and our facilities can support the high throughput needed to supply expanding patient populations once products reach commercial realization. |
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| Pharmaceuticals and Consumer Health Webinar: “Integrated Clinical Development and Supply-Breaking Down the Early-Development Journey of a Small Molecule” In the era of seamless drug development, reducing time to the clinic and getting rapid regulatory approval has become the goal of nearly every early drug development sponsor. Handling drug development, manufacturing, and clinical supply efficiently can help sponsors save costs and provide maximum benefit for patients. To improve the efficiency of the drug development continuum, integrated solutions have become an effective option for sponsor companies to streamline a program’s transition from early development to the clinic, in addition to providing timely clinical supplies to help keep study timelines and budgets on track.
Article: “The Pandemic’s Impact on Over-the-Counter Cough and Cold Product Innovation” As the consumer health industry emerges from a slowdown in innovation due to the pandemic, Catalent Consumer Health keeps a close watch on the global market to identify key trends, innovation opportunities, and performance across categories. In this article, Catalent experts examine how the pandemic has impacted cough and cold products innovation, and what this means for the market. |
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| | | Biologics Catalent’s fully integrated approach to cell and gene therapy development and manufacturing begins with critical starting materials including plasmid DNA (pDNA). We have a network of plasmid DNA clinical and commercial manufacturing sites in the US and Europe. Watch this site tour of Catalent’s Rockville, Maryland, facility featuring pDNA manufacturing capabilities as well as analytical and process development labs to learn more about our scalable operations. | Pharmaceuticals and Consumer Health 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. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions. |
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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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