| | Latest News | Catalent Expands OneBio® Suite for Integrated Development, Manufacturing and Supply Across Biologic Modalities | Catalent has expanded its integrated development, manufacturing and supply solution, OneBio® Suite, across a range of biologic modalities, including antibody and recombinant proteins, cell and gene therapies, and mRNA. Under the newly expanded OneBio offering, customers will continue to benefit from an integrated contract and proposal, harmonized project management, a global development and manufacturing network, and diverse expertise, now across biologic modalities and service offerings. |
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| | Learn More | Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development |
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| Catalent has expanded the services and capabilities at its facility in Shiga, Japan, to include the storage, kitting, and distribution of advanced therapies at ultra-low temperatures for clinical trials. State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of |
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| investigational advanced therapy products by minimizing their time-out-of-environment. “The market in Japan for advanced therapies and new modalities continues to grow, along with the demand for companies such as Catalent that have the advanced infrastructure to handle the supply and distribution of these highly sensitive products, as well as the specialized expertise and comprehensive knowledge to manage these supply chains,” commented Tadahiro Matsumura, Catalent’s President of Japan. | | Learn More |
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| | | Streamlining and Standardizing Process Characterization | Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks. Discover how a deep understanding of process characterization can drive successful clinical phases and accelerate commercial launch of biological drug development. Dive into the insights shared in BioPharm International's May 2023 Partnerships for Outsourcing eBook. |
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| | | Catalent for Building Better Biotechs | Plasmid DNA and Advanced Therapies: Accelerating Path to Clinic |
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| Gene therapies and emerging biomodalities are developing at an unprecedented pace, improving the lives of patients around the world. The starting point for advanced therapies is generally DNA in the shape of plasmid DNA (pDNA). GMP requirements from early stage, together with the right |
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| tools and analytics providing the highest quality standards for pDNA, will ensure successful downstream applications as AAV, from early clinical development to commercial phase.
Join this webinar for an in-depth discussion of the challenges cell and gene therapy innovators face and how experts resolve these barriers through adopting technology and strategy that drive an optimized plasmid production process and supply.
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| Upcoming Events: Join Our Experts to Hear the Latest on Technology Development Programs and Commercial Programs |
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| Biologics
Webinar | Accelerating your Gene Therapy to Patients: Not All Platforms are Created Equal | June 22, 2023 | 11:00 a.m. EDT Join this webinar to learn how standardized processes impact the timeline, development and manufacturing efficiency of AAV vectors to the clinic. In this fireside chat, experts George Buchman, Ph.D., Vice President, Pre-Clinical and Process Development, Catalent Cell & Gene Therapy, and Thomas VanCott, Ph.D., Chief Scientific Officer, Combined Therapeutics, will explore how a complete platform approach to fast-track AAVs can enhance quality and efficiency. |
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| Pharmaceuticals and Consumer Health
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 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 Ph.D., Group Lead, Product Development, in her presentation titled ‘Considerations for Lipid-based Formulations (LBFs) from Preclinical Toxicology to Clinical Studies’ to hear drug development strategies 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’, where he will 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 or delayed/modified release applications.
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Biologics Webinar:SMARTag® Technology, from Bertozzi Lab to Best-in-Class ADCs Join this webinar as Chemistry Nobel Laureate, Carolyn Bertozzi, Ph.D., Catalent’s Penelope Drake, Ph.D., and Seema Kantak, Ph.D., from Exelixis, discuss the latest trends in antibody-drug conjugate discovery and development.
Article:The Current State of the Cell Therapy Market: Q&A with Maria Lopez, General Manager, US Cell Therapy at Catalent Biologics Cell therapy holds such potential but there are many challenges and logistical hurdles that innovators must work through to be able to bring promising treatments to patients. Catalent’s Maria Lopez, General Manager of U.S. Cell Therapy discusses the current state of the cell therapy market and the ways Catalent is working to overcome some of these challenges. Based on an interview conducted by, and published in, BioBuzz.
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| Pharmaceuticals and Consumer Health |
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| | | | | In this 360° Virtual Tour of Catalent’s site in Limoges, France, the European center of excellence for early-phase clinical biologics formulation development and small-scale drug product fill/finish. |
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| Pharmaceuticals and Consumer Health |
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| Take a virtual 360-degree tour of Catalent’s Greenville, North Carolina, facility, which specializes in end-to-end turn-key solutions for oral solid dosage forms. With fit-for-scale capacity and potent handling capabilities, this state-of-the-art facility is perfect for targeted or orphan drug development, and features fully integrated formulation development, analytical services, manufacturing, and packaging. |
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