| | John Chiminski Interviewed by
Investor’s Business Daily |
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| Following Catalent’s announcement that it plans for John Chiminski to assume the position of Executive Chair of the Board when Alessandro Maselli becomes its new CEO from July 1, 2022, John was interviewed by Investor’s Business Daily” about his leadership style, and how Excellence, Innovation and Growth have been key drivers of the company's success. |
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| | | New Xpress Pharmaceutics™ Service Launched to Expedite Development of Oral Drugs for Adaptive Phase 1 Clinical Trials |
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| Catalent announced the launch of its new Xpress Pharmaceutics™ service, designed to accelerate the development of oral drugs through Phase 1 clinical studies. By integrating formulation development, on-demand clinical manufacturing, regulatory support and clinical testing, the approach can reduce both the cost and time taken to complete first-in-human trials. “By focusing on the areas that are crucial for fast progression to, and through, Phase 1 trials, Xpress Pharmaceutics can potentially halve the time to complete studies.” said Jonathan Arnold, President, Oral and Specialty Delivery at Catalent. |
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| | | Specialized Packaging Capabilities Increased at Catalent’s Philadelphia, US, Facility to Support Growing Biologic and Cell and Gene Therapy Markets |
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| To support increased demand for the distribution of biologic drugs, and advanced cell and gene therapies, Catalent announced that it has increased cold chain packaging capabilities at its Philadelphia facility.
Work has been undertaken at the 200,000 square-foot facility to expand the packaging area by around 20,000 square feet and includes the addition of seven new temperature-controlled processing suites, which can operate at either refrigerated or frozen conditions and precisely match the needs of the investigational medicinal products being handled. Catalent’s Philadelphia facility is the largest in its global clinical supply network and the company’s North American Center of Excellence for clinical supply packaging. |
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| | | Catalent Completes $10 Million Expansion of High Potency Micronization Capabilities in US and the UK |
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| State-of-the-art large-scale isolator units at Catalent’s Malvern, Pennsylvania, and Dartford, U.K., facilities, to provide advanced containment capabilities for the micronization of highly potent drug compounds.
“Micronization is a well-established technology to help improve the solubility |
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| of oral drugs and there continues to be a growing need for safe manufacturing and containment technologies required for the development of highly potent APIs,” commented James Walter, Vice President Operations, Oral and Specialty Delivery at Catalent. “These expansions provide the increased capacity needed to meet current and future demand for high potent, high value micronization.” |
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| | | | | Fierce Pharma: Catalent, Still Buzzing with Pandemic Momentum, Taps COO Maselli To Succeed Chiminski as Chief Executive After two banner years on the forefront of COVID-19 vaccine production, contract manufacturing juggernaut Catalent has unveiled a changing of the guard. On July 1, Catalent's current president and chief operating officer Alessandro Maselli will take up the mantle of chief executive officer. He'll succeed long-time CEO John Chiminski, who's slated to become executive chair of the CDMO's board of directors. | | Read More |
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| | | The Analytical Scientist: Rising to the Analytical Challenge of Advanced Medicine Cell and gene therapies are incredibly exciting, but without the right predictive analytical methods and tools to ensure safety and efficacy, the field will be held back. The establishment of analytical methods that can demonstrate true comparability is of critical importance – just as important as advancements and improvements in manufacturing methods, which is a major talking point within the field. | | Read More on The Analytical Scientist |
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| | | Drug Development & Delivery: Analytical Testing Trends in 2022 | Catalent: Innovative Mass Spec Approach Enables Faster Filing |
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| Catalent has extensive experience and the capabilities to perform analytical testing on a variety of dosage modalities including mRNA, mAbs, cell and gene therapy products, and several dosage forms, including solid oral dosages (capsules, tablets, softgels), inhalation products, and injectables. |
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| Catalent also has expertise in characterization, spanning techniques from residue level analysis up to higher order structure (HOS) using state-of-the-art instrumentation across spectroscopy, biophysical, bioassay, and mass spectrometry. | | Read more on Drug Development & Delivery |
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| Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs |
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| | | Biologics
BEBPA 2022 US Bioassay Conference | Virtual | March 21-24, 2022
Schedule a Meeting with Catalent at this event
BIO-Europe Spring 2022| Virtual | March 28-31, 2022
Schedule a Meeting with Catalent at this event
12th Annual World ADC London | London, UK | March 29 - April 1, 2022
Schedule a Meeting with Catalent at this event
Hear our expert, Ayodele Ogunkoya, Ph.D., Sr. Research Scientist, Chemistry, Catalent Biologics, present “SMARTag® ADC Technology Delivers on the Fundamentals to Support Best-In-Class Asset Development.”
Cell and Gene Therapy
Next Generation CAR-TCR Summit 2022| London, UK | February 22-24, 2022
Schedule a Meeting with Catalent at this event Learn from our expert Joe Codamo, Senior Account Director, Catalent Cell & Gene Therapy, as he presents “Flexible and Innovative Design Considerations for Cell Therapy Processes and Facilities.”
5th Annual Gene Therapy for Rare Disorders | Boston, Massachusetts | March 7-10, 2022
Schedule a Meeting with Catalent at this event
Clinical Supply Services
Clinical Trial Supply New England 2022 | Boston, Massachusetts | March 8-9, 2022 Visit with our Catalent’s Clinical Supply services experts in Booth18 to learn more about our integrated development & clinical supply services.
Clinical Trial Supply Europe 2022 | Madrid, Spain | March 22-23, 2022 Meet with Catalent’s Clinical Supply services experts at Booth 36 to discover how Catalent can help you excel in clinical supply strategy. Schedule a Meeting with Catalent at Clinical Trial Supply Europe 2022
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Oral & Specialty Delivery
RDD2022: Respiratory Drug Delivery | Orlando, Florida | May 1-5, 2022 Meet with Catalent’s experts in applied drug delivery experts in Florida and discover how we can support your respiratory drug delivery needs. Click here to schedule a meeting with our team at the event.
2022 Controlled & Modified Drug Release Summit | Philadelphia, PA - Hybrid | May 23-24, 2022 Join a presentation with Ron Vladyka, Director, Scientific Services, Catalent for a presentation titled ‘Twin Screw Granulation: A Novel Process for Modified Release Formulation’ where he will introduce a novel twin screw granulation process for the development of controlled release formulations. In addition, a review of top considerations will be shared in determining the appropriate technology for modified release dosage form manufacturing.
Consumer Health
MakeUp in Los Angeles | Los Angeles Convention Centre, California | February 23 - 24, 2022 Meet our Catalent beauty experts in Booth B41 and explore how we can partner to help 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 together, we can bring nutritional supplement products to life! Register today and schedule a meeting with our experts.
In-Cosmetics Global 2022 | Paris, France | April 5 – 7, 2022 In-Cosmetics is all about the beauty of collaboration - connecting producers and suppliers of raw materials, fragrances, lab equipment, testing and regulatory solutions with researchers and buyers from personal care brands. We invite you to join in. Click here to schedule a meeting with Catalent at this event today |
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| A Catalyst in Drug Development |
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| Kirk Reynolds, Ph.D. Senior Scientist, Injectable Formulation Development, Catalent, San Diego |
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| Kirk Reynolds, Ph.D. is a Senior Scientist, for Injectable Formulation Development, at Catalent’s San Diego, California Facility. Dr. Reynolds specializes in early phase formulation development for parenteral products just leaving discovery. He also works on pre-clinical and early phase development of the latest therapies across a broad range of injectable delivery routes. Discover what drives his passion for injectable formulation development, read his published works, which include four peer-reviewed articles. |
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| | Biologics
Webinar: “ mRNA-A 20 Year Voyage to Patients” - EuropaBio hosted the final event of its 25th Anniversary program by focusing on the story of mRNA, its first steps into commercial development, the challenges of bringing vaccines to millions of people, and its utility beyond Covid featuring in oncology treatments and for other significant health applications. Join this webinar to learn more. Article: " The New Normal: How the Supply Chain has Been Impacted by COVID-19” - As a global development and manufacturing partner that supplies medicines, clinical trial materials and health products to millions of patients and consumers, Catalent needed to balance its work on thousands of products while also supporting the scale up of COVID-19 vaccines and therapies for over 60 customers from small and virtual biotechs to mid-sized and large pharma. In this Q&A, Catalent discusses the challenges it faced and solutions it implemented to overcome this daunting challenge. Webinar: " Women in BioPharma Awards 2021” – In this webinar, Catalent’s VP of Strategic Partnerships, Kimberlee Steele, presents awards to a group of 20 extraordinary women who are making lasting impacts in the drug development field. Learn more about how these women became the leaders they are today as we bring their stories to a live virtual audience. Podcast: " Leveraging N-1 Perfusion for Higher Productivity and Quality for Biologics” - N-1 perfusion is the application of the perfusion technology in the step immediately before the production bioreactor. It is a good option for processes that exhibit low productivity.Join Claudia Berdugo, Ph.D., Director of Process Development at Catalent Biologics, for a podcast where she discusses N-1 perfusion and how Catalent Biologics works toward process improvements for each client to enable them to move their pharmaceutical products forward with confidence. Webinar: " Strategies to Accelerate the Path to Clinic for Next-Generation Antibodies” - The next-generation antibodies, particularly antibody fragments, possess an increased level of complexities and technical challenges that may result in longer CMC development timelines and delay to clinical trials, as well as commercial launches. In this webinar, experts discuss formulation development and purification strategies to increase throughput, reduce operating costs and potentially decrease development times for monoclonal antibody fragments.
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| Cell & Gene Therapy
Ebook: " Cellular Starting Materials In Focus” – Cellular starting materials are a crucial aspect in the development of cell therapies. However, starting materials that involve a cell preparation can be a significant source of variability when it comes to the final product, especially when considering donor-specific cells. In this ebook, we bring you expert insights into the advantages that various cellular starting materials have, with a particular focus on human induced pluripotent stem cells (iPSCs). Video: “ An Interview: Potential of iPSCs”- In this informative 30-minute interview, Boris Greber and Thomas Marx answer questions about the position of iPSCs in today’s advanced therapies market and the transformative power latent in their clinical application.
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Clinical Supply Services
Webinar: " Running Decentralized Trials at Scale" - The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele-visits, digital consent, new monitoring sensors, and direct-to-patient supply are virtual tools that existed before the pandemic. But now there’s a swift adoption of these methods because they’ve been proven to help launch and complete trials more effectively. This Endpoints News webinar assembles a panel of clinical experts who are already running the trials of tomorrow. Video: " Clinical Supplies for Japan Studies" - Catalent’s clinical supply packaging facility in Shiga, Japan, is strategically located between Tokyo and Osaka. One of largest clinical supply sites in Japan, the 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service throughout Japan.
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| Oral Drug Delivery
Fact Sheet: “ Xpress Pharmaceutics™ – Integrated Development Offering to Facilitate Adaptive Trials & Accelerate Phase 1” - Catalent Xpress Pharmaceutics™ is an advanced development offering that integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient First-in-Human studies and fast development. Article: " Outsourcing Pharma Manufacturing – Keys to Successful Technology Transfers” - Learn more about a systematic approach to ensure tech transfers meet scheduled timelines. Pharmaceutical Technology magazine recently spoke with Mike Valazza, Vice President Business Development, Oral & Specialty Delivery at Catalent, about some of the factors that should be considered when making this decision. Summary: " Overcoming Manufacturing Challenges for Accelerated Drug Development” - Learn how to leverage the drug development knowledge and build a strategy that maintains the integrity, quality, and timeliness of the manufacturing process. Download the executive summary to get expert insights on overcoming manufacturing challenges that are associated with expedited development programs. Webinar: " Maintaining Drug Product Properties and Optimizing Late-Stage Manufacturing Efficiency” - In this webinar, experts provide an overview of the latest trends in manufacturing of oral solid dosage form and discuss key considerations of transitioning an early-stage project to late-stage as well as technology transfer. Discover how multivariate modeling tools can help scientists understand the relationship between critical material attributes and critical process parameters, and how they impact the finished dosage form in large scale production. Summary: ”Mapping the Pathway to Designing Successful Treatments” - This executive summary includes evidence on how the right guidance at the right time can help you create more successful treatments. Experts introduce Catalent’s new OptiDose® Design Solution, an integrated dose form design strategy based on an analysis of the molecule, patient and market. Learn how this solution can deliver dose form recommendations that can help differentiate your product, improve customer acceptance, and turn your science into patient accepted and commercially successful medicines.
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| Consumer Health Fact Sheet: " Gummy Delivery Technologies”- Gummy technology offers a chewable experience to deliver dietary supplement products with multiple options and customizations to bring your gummy product to life. Fact Sheet: " Lozenge Delivery Technologies”- Lozenge technology offers a unique and innovative delivery method to create an enjoyable supplement experience. Fact Sheet: “ Soft Chew Delivery Technologies” - Soft Chew technology offers a chewable experience to deliver dietary supplement products in an uncooked or cold-process that creates new opportunities in chewables.
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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 Therapies -
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. - In this 360° virtual tour, explore Catalent’s Harmans/BWI-1 clinical and commercial manufacturing facility for gene therapies in Baltimore, Maryland. At approximately 200,000 sq. ft., this state-of-the-art, FDA-licensed facility houses 10 CGMP manufacturing suites including fill/finish, and contains central services labs, testing labs, and acts as a central warehouse and supply chain hub for Catalent’s gene therapy solutions.
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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, Massachusetts, 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 CGMP 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 more.
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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