| | | | The Golden Age of Drug Delivery |
|
| “Newer modality pipelines, such as viral vector-based gene therapy and autologous/allogeneic cell therapies, have reached critical mass and are growing at mid double-digit rates. Emerging modalities – such as mRNA-based therapies, non-viral vector-based gene therapies, exosomes, and microbiome treatments – are small today, but may be even faster growing if clinically successful. |
|
| And proteins – monoclonal and multi-specific antibodies and fusion proteins in particular – form a large share of this pipeline,” shared Cornell Stamoran, Ph.D., Catalent’s VP of Corporate Strategy and Government Affairs, on how the last few years of pharmaceutical industry trends are affecting the drug delivery landscape. | | Read More |
|
| The Medicine Maker Power List 2023 |
|
|
The Medicine Maker asked readers to nominate the people enabling progress in the small molecule, biopharmaceutical, and advanced therapy spaces. Catalent celebrates Victor Vinci, Ph.D., VP Global Product Development, Cell, Gene and Protein Therapies, Catalent, being recognized in the magazine's 2023 Power List in the Advanced Medicines category!
|
|
| | | Pharma companies developing new injectable medicines are aiming to meet more patient needs. To meet this demand, CDMOs such as Catalent are adding more high-speed, state-of-the-art assembly solutions, which are able to accommodate these innovative devices. |
|
| Catalent Biologics’ drug product facilities in North America and Europe provide integrated solutions for customers developing new biological entities, biosimilars, and sterile injectables. These include early-phase development and manufacturing to late-phase commercial fill-finish and packaging. | | Read More | Intranasal Drug Delivery: the challenges and opportunities |
|
| The intranasal delivery route is commonly used for the local treatment of allergic rhinitis and cold symptoms, but it is also recognised as an alternative systemic drug delivery route for a variety of indications, including migraine, seizures, breakthrough pain, opioid overdose and, more recently, for the treatment of COVID-19. Read this article to explore the considerations and opportunities for the development of intranasal products. |
|
| | Read More | Spray drying to enable new inhaled drug products |
|
| Formulating an inhalable dry powder product and designing the associated spray-drying process requires understanding the properties of the ingoing API, the utility of the available excipients and the process parameters connected to product quality attributes. |
|
| Catalent experts share insights on concepts and considerations for engineering inhaled powders and their application in next generation therapies | | Read More | Catalent for Building Better Biotechs | How Working with a Consultant Can Help Your Biotech Business |
|
| Making the decision to work with a consultant during the journey to a drug’s regulatory authorization can help smooth out many bumps along the way. But transparency, full and clear communication, and industry experience, are essential parts of a successful partnership. |
|
| The development process for any new compound is fraught with potential problems, conflicts and delays. Working with a skilled and experienced consultant with a great reputation can smooth the process and help ensure a compliant path to authorization.
Download Article
Featured event:
Road to IND: Accelerating Development & Manufacturing of Biologics | JLABS @ San Diego | June 13, 2023
Filing an Investigational New Drug (IND) application is a critical milestone for every biopharmaceutical company specialising in development of cell and gene therapies. Companies need to be well-versed and understand the intricacies of key components in the development of an IND application including the cell line development, production optimization, analytical assay development and qualification, scale-up to CGMP manufacturing, and quality control and assurance. This in-person seminar is designed to be a valuable resource for those involved in the development of biologic drugs including researchers, drug developers, C-suite executives of biotech companies, and regulatory affairs professionals. |
|
| Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs and Commercial Programs |
|
| Biologics
5th Annual Allogeneic Cell Therapies Summit | Boston, Mass. | May 22-25, 2023 Meet our Catalent expert in booth 3 to learn about our broad expertise across CAR-Ts, MSCs, iPSCs, and ESCs for process development, manufacturing, and fill & finish capacities to accelerate the path to commercialization for allogeneic therapies. Webinar | CGMP-Compliant iPSC Manufacturing and Development of Differentiated Cells for Advanced Therapies: Strategies and Challenges | Tuesday, May 30, 2023 | 9:00 a.m. EST / 2:00 p.m. BST / 3:00 p.m. CEST Join this webinar as experts will discuss the current state-of-the-art for induced pluripotent stem cell (iPSC) generation and differentiation. The presentation will highlight the development of advanced CGMP-compatible protocols for converting these cells into several cell types of therapeutic relevance, including retinal pigment epithelium (RPE), mesenchymal stem cells (MSCs), cardiomyocytes (CMs), and immune natural killer (NK) cells. There will also be discussion on the quality of iPSCs as starting material for clinical use and the development of meaningful assays to assess purity and impurities in the product and to monitor potency. ISCT 2023 Paris Annual Meeting| Paris, France | May 31 – June 3, 2023 Connect with our Catalent experts and learn more about our early development to commercial-scale manufacturing capabilities for autologous and allogeneic cell therapies, including off-the-shelf and custom iPSC banks, MSCs, exosomes, and HSCs.
2023 BIO International Convention| Boston, Mass. | June 5-8, 2023 Visit Catalent in Boston at booth 785 to speak with a specialist on how Catalent Biologics’ integrated solutions across proteins, cell and gene therapies, and other modalities can accelerate your timelines.
ISSCR 2023 Annual Meeting| Boston, Mass. | June 14-17, 2023 Join Catalent in Boston at booth 525 and schedule your meeting with our cell and gene therapy experts on our integrated capabilities from iPSC GMP cell banks and plasmid DNA supply through clinical & commercial-scale manufacturing for advanced therapeutics. In addition, hear Boris Greber, Head of R&D iPSC/CT, present at Catalent’s innovation showcase with a session titled “New differentiation workflows and GMP-compliant iPSC lines for cell therapy” on June 16. |
|
| Pharmaceuticals and Consumer Health
Webinar| Targeted Protein Degraders: Through the Lens of the Innovation, Developability, and CMC Challenges | May 23 11:00 a.m. EDT In this webinar, experts will review the trends and challenges associated with the rational design of targeted protein degrader drugs. This will be followed by a discussion on the developability assessment of this class of molecules that leverage novel models to account for, and serve to predict, their oral bioavailability. In addition, experts will share perspectives on how to inform the selection and development of orally bioavailable drugs, and CMC approaches to efficiently develop and manufacture targeted protein degraders.
Clinical Trial Supply Forum 2023 | Brussels, Belgium | May 23-25, 2023
Meet our Catalent clinical supply experts at booth 28 to explore how our integrated solutions in Europe and globally can help overcome your clinical trial supply challenges. Webinar | Proactive Strategies to Evaluate and Mitigate Clinical Supply Risk | May 24, 2023 Join this webinar as Julie Delany, Site Director, Catalent Singapore focuses on strategies that build an understanding of risk assessment within clinical supply planning, as well as how studies’ protocol requirements, drug characteristics, packaging specifications, and patient compliance concerns must be identified and addressed in order to mitigate risk to help achieve successful clinical supply outcomes. Julie will also discuss packaging and clinical supply chain services for global clinical trials with a specific focus on APAC region. Global DDF Summit 2023 | Berlin, Germany | May 31- June 2, 2023 Join Catalent’s expert Steven Winling Scientific Advisor, Science & Technology, Catalent, as he discusses how developability assessment strategies for protein degraders might differ from typical small molecule development. In addition, an array of specialized downstream capabilities and CMC strategy that drives success at each milestone from development to clinics will also be presented.
Webinar | Mitigating the Risk of Pitfalls in Nasal Drug Product Development, Testing and Manufacturing | June 8, 2023 | 10:00 a.m. EDT Over the past five years, the increased approval rate of intranasally delivered molecules has provided evidence of growing interest in the nasal route for both local and systemic administration. In this webinar, experts will discuss problems common to the development, testing and manufacturing of intranasal drug products, their potential causes, and possible consequences. Experts will then make recommendations for preventing them, or mitigating their effects.
DIA China 2023| Suzhou, China | June 16-19, 2023 Schedule a meeting with our clinical supply experts at booth E11 to learn more about our extensive world-leading capabilities and network in China, APAC and beyond can help you overcome your clinical supply challenges & keep your trials on track for success.
Webinar | Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-based Formulations | June 13, 2023 | 11 a.m. EDT In this webinar, experts will offer insights into the perceived barriers to developing Lipid-based Formulations (LBFs) and recent advances in translating them into useful clinical and commercial products of lipophilic drugs. Experts will also discuss lipid excipients from the perspective of dosing in preclinical models for toxicology studies and their safety profile.
2023 Global Drug Bioavailability Enhancement Summit | Princeton, New Jersey | June 27-28, 2023 Join Catalent’s Ellie Au, Group Lead, Product Development, Catalent, in her presentation titled ‘Considerations for LBFs from Preclinical Toxicology to Clinical Studies’ to learn more about how to successfully transition preclinical LBFs to viable clinical dosage forms.
2023 Controlled & Modified Drug Release Summit | Princeton, New Jersey | June 27-28, 2023 Catalent’s Global Vice President, Rx Product Development, Karunakar (Karu) Sukuru, R.Ph., Ph.D., will be presenting ‘Patient Centric Product Development’ to share insights into the advances in softgel technology and new design variants that can help deliver medication through various routes of administration including oral, topical, ophthalmic, and vaginal whether for immediate release or delayed/modified release applications. |
|
|
|
Biologics Webinar: Exploring a One-Stop Integrated Solution for AAV Vector Clinical Production Every choice is critical in adeno-associated virus (AAV) vector production. Join this webinar to learn more about how a right process with clonal HEK293 cell line, and range of off-the-shelf plasmids, along with qualified analytical methods supports a robust supply chain for the development and manufacture of AAV vectors, and the reduction of timelines to clinical evaluation. Webinar: Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing Process characterization and validation is an important step in the product development journey and late-phase development. In some cases, process optimization is required for an existing manufacturing process before process characterization begins. In this webinar, Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline. Fact sheet: Drug Product Manufacturing in Anagni – Infocard Catalent’s Anagni facility is a world-class, late-stage and commercial product launch site offering sterile and biologics manufacturing and secondary packaging with extensive expertise in aseptic liquid vial filling. |
|
| Pharmaceuticals and Consumer Health Webinar: How Unit Dose Delivery Meets Today’s Beauty and Skin Health Trends The beauty and skin care market is constantly adapting in response to market trends. In this webinar, experts discuss which consumer trends will have the greatest impact on the beauty and personal care market, and how partnering with a market leader in unit-dose technology may help brands stay ahead.
Webinar: Modern Modelling Tools for Small Molecule Solid Dose Manufacturing In this webinar, industry experts provide a comprehensive overview of the current trends for oral solid dosage forms, highlighting how manufacturing technologies have needed to adapt to meet changing market demands. Discover the power of modeling tools in improving scale-up efficiency and learn why an agile approach to operations is key to balancing capacity with speed.
Executive Summary: Critical Supply Strategies for CROs Discover the best practices in the pre-award phase that a CRO can employ to build a functional relationship with their clinical supply partner, solidify a compelling strategy, and drive alignment for success. Learn more. |
|
| | | | | In this 360° Virtual Tour of our site in Limoges, France, explore Catalent’s European center of excellence for early-phase clinical biologics formulation development and drug product fill/finish. |
|
| Pharmaceuticals and Consumer Health
| Catalent’s clinical supply facility in San Diego provides comprehensive services to meet a variety of clinical trial supply needs for pharma and biotech companies, including but not limited to primary and secondary packaging as well as clinical storage and distribution (including cold chain support). Click here to explore. |
|
| We are the Catalyst for your success. Join us! |
|
| 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 hiring across sites in North America, Latin America, Europe and Asia Pacific.
Visit www.catalent.com/careers for more information. |
|
| | |
|
Every molecule has a challenge. We have a solution.
|
|
| | | or call +1 877 891 9609 to speak with one of our experts today! |
|
| | |
|
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.
© 2023, Catalent Pharma Solutions, Inc. 14 Schoolhouse Road, Somerset, NJ 08873. All rights reserved.
|
|
|
|
|
