|
|
|
| Bridging Development and Regulation in CGT with Halloran Consulting Group's Monika Swietlicka | On Cell & Gene: The Podcast, Erin Harris speaks with Monika Swietlicka of Halloran Consulting Group about the top regulatory hurdles facing cell and gene therapy developers. From manufacturing challenges to clinical trial design and FDA expectations around gene editing, Swietlicka shares key insights. She also discusses the growing importance of early quality planning, comparability strategies, and real-world evidence—especially critical for rare disease treatments with limited trial data. |
|
|
|
|
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections. |
|
|
| Unlocking Flexible AAV Production | Article | By Artur Padzik, Ph.D., 3PBIOVIAN | Discover how 3PBIOVIAN’s advanced plasmid manufacturing and AAVion® platform can drive your AAV program forward by reducing production costs while maximizing efficiency. |
|
|
| Pioneering Plasmid-IQ Design | White Paper | SK pharmteco | Gain insights into the significance of plasmid design in viral vector production and the use of analytical assays and Next-Generation Sequencing for plasmid verification. |
|
|
| Powering Drug Development With Precision LC-MS/MS Bioanalysis | White Paper | By Uday Velagapudi, Ph.D., Pace Life Sciences | Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development. |
|
|
| Transforming Patient Access To CGT | Q&A | Cryoport Systems | Chief Commercial Officer Aruna Mor recently delivered a powerful keynote at the Advanced Therapies Congress in London, highlighting the challenges of patient access to advanced therapies. |
|
|
|
|
| Comprehensive Cell Solutions Capacity Update April 2025 | Video | Comprehensive Cell Solutions, A Business Unit of NYBC Enterprises | Discover how NYBCe and CCS are transforming cell and gene therapy development with end-to-end CDMO solutions, advanced logistics, and a growing innovation hub in Louisville. |
|
|
|
|
|
|
|
|
|
|
| Connect With Cell & Gene: |
|
|
|
