Nordic Pharma’s Post

Thoughts on this? >> Ascend takes Beacon’s manufacturing assets; 89bio’s $135M build in China >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #biotech #productmarketing #pharmaceutical

Thoughts on this? >> Ascend takes Beacon’s manufacturing assets; 89bio’s $135M build in China >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #productmarketing #pharmaceutical #healthcare

ECI’s INTEGRATED CONTINUOUS BIOMANUFACTURING ( ICB)  VI here in  Leesburg, Virginia has been truly enlightening, we are really coming to a turning point in the industry with regards to integrating continuous manufacturing.  Particularly exciting was a regulatory session where  highlights included  Dr Peter Marks #FDA who gave the Keynote Presentation on the Central Role of Manufacturing for #ComplexBiologicProducts , Rebecca Berger from #Sanofi shared her #Regulatory Journey of integrating #Continuousmanufacturing at Sanofi over the last 10 - 15 years and @Riley Myers gave the #FDA perspective on the future of biomanufacturing explaining notably how #CDER supports innovative technologies through 3 cross cutting Programs #TheEmergingtechnologyProgram, #FrameworkforRegulatoryAdvancedManufacturingEvaluation #AdvancedManufacturingScienceandResearch Through engaging early with the #FDA through the above programmes this can result in faster drug approvals, sharing and gaining feedback on new technology innovations. Breaktime here in Virginia- glorious autumn sunshine!

Yesterday, Wheeler Bio, Inc.'s Chief Manufacturing Officer Yuk Chun Chiu delivered two great presentations at KENX's Validation University Conference. Here, Yuk gave his insight into utilizing risk-based approaches in the commissioning, qualification, and validation (CQV) of single use systems (SUSs) followed by practical considerations for the implementation of a data infrastructure for advanced analytics. We are very proud to have such a great mind representing Wheeler and sharing his knowledge and experiences with the industry. If you did not get the chance to attend Yuk's ISPE or KENX talks, keep an eye out for more great presentations coming later this year! #Bioprocessing #Biopharma #Pharma #Biotech #Innovation

Always Leading with Technology!!

This is going to be our biggest year yet! The technology in all of these areas is advancing rapidly, so I have no doubt there some great ideas out there for presentations. I would personally love to hear some new ideas around the way we work in these areas. Our talks tend to focus on the process or product but who is advancing the people aspect. With the rise of AI copilots and other efficiency gains, how are people changing the way we innovate, implement, and manage lifecycle? ❓Do we still need $$$$$$ consultant firms to tell us what to do or can I employ AI? ❓Have we found ways to ease and speed Digital Transformation to Pharma 4.0? ❓Are equipment vendors more tied into what the customers need and want? ⁉️Why do I still see so much Paper?!!!! ❓Who is working on the logistics nightmare that is Autologous Ex-vivo Cell Therapy? ❓Where are all the digital twins? 🤨 Yada Yada Yada, I need to know! Get those proposals in!!!

Nathalie Huther participated in a panel at the Kadans Innovation Summit organized by Kadans Science Partner in London, joining industry leaders to explore the opportunities and challenges of advancing life sciences manufacturing in Europe. The discussion centered on implementing innovative solutions to enhance efficiency and speed, while also addressing sustainability goals and ensuring resilience against potential supply chain disruptions. #sailifesciences #europe #pharma #cdmo #cro #supplychain

Just reflecting on four inspiring days at the Integrated Continuous Biomanufacturing Conference (ICB VI) in Leesburg, VA last week. It was incredible to be part of the collaborative spirit driving the future of biomanufacturing. Some key takeaways: * Early Wins: Early adopters are already reaping the rewards of ICB in GMP. Reporting tangible improvements in timelines, efficiency, and sustainability. * A Bright Future: Emerging technologies like digitalization, process analytical technology (PAT), and novel downstream processing (DSP) technologies are poised to revolutionize biologics manufacturing and streamline ICB implementations. * Aligning for Success: The key to successful ICB implementation lies in aligning business goals with the right technologies and strategies. Even partial adoption can yield significant benefits, tailored to specific operational needs. Looking forward to ICB VII next year and the continued advancements in biomanufacturing!

Thrilled to have industry expert Jennifer Riter, VP and Global Head of Analytical Business Unit at Kindeva Drug Delivery, join us at Combination Products Summit! With the evolution of combination products along with the complex interactions with packaging components and delivery systems, it is critical to understand the compatibility and performance of the packaging and delivery systems for the successful development of a combination product. Applying a systematic approach and strategy for the constituent parts as well as the system qualification is critical in ensuring product quality. It is important to understand the physical, functional and chemical compatibility of these components and systems. There are several key areas to assess during development which includes performance, extractables and leachables and container closure integrity (CCI). There are also several techniques to consider when assessing and qualifying the containment system as well as the delivery system. This presentation will educate and provide examples of an analytical strategy and approach for combination products. Kindeva is also an event sponsor at Combination Products, be sure to stop by their booth and say hello 👋 ! Join us at Combination Products Summit or learn more about the event: https://lnkd.in/eY8w4jNc #combinationproducts #containerclosure #medicaldevices #drugdevices #analyticaltesting #pharmaevent