Miltenyi Biomedicine’s Post

Why choose adthera as your cell therapy partner? info@adthera.bio #cdmo #regenerativemedicine #digitalfirst #celltherapy #immunotherapy #innovation #processdevelopment #continousimprovement #gmp #clinicaltrials #atmp #advancedtherapies #personalizedmedicine #gxp #optimization #automation #bestinclass #rightfirsttime

Turning Cell Therapy Challenges into Opportunities! Dive into Cellistic's journey of iPSC differentiation and GMP facility development. Learn how Cellistic's capabilities help you navigate manufacturing challenges, ensuring your therapies reach patients faster: https://hubs.ly/Q01-9srP0 #GMPfacility #celltherapymanufacturing #celltherapy #allogeneiccelltherapy

Great to see an additional approval from FDA today for #Abecma in r/r multiple myeloma for patients that had recieved at least 2 lines of prior therapy! The approval is based on results from the phase 3 KarMMa-3 trial (NCT03651128), in which Abecma (ide-cel) was compared with standard-of-care (SOC) therapy. At the primary progression-free survival (PFS) analysis with a median follow-up of 15.9 months, the median PFS was 13.3 months (95% CI, 11.8-16.1) in the ide-cel arm vs 4.4 months (95% CI, 3.4-5.9) in the SOC arm (HR, 0.49; 95% CI, 0.38-0.64; P <.0001). Additionally, the 6-month PFS rate was 73% vs 40%, and at 12 months it was 55% vs 30%.2. Greater than 3x the length of progression free survival in the Abecma vs SOC arms. A win for patients, providers and cell therapy developers today. #celltherapy #cellandgenetherapy #celltherapymanufacturing #advancedtherapy #multiplemyeloma #regulatoryaffairs https://lnkd.in/gyd8Ufid

Turning Cell Therapy Challenges into Opportunities! Dive into Cellistic's journey of iPSC differentiation and GMP facility development. Learn how Cellistic's capabilities help you navigate manufacturing challenges, ensuring your therapies reach patients faster: https://hubs.ly/Q0247bmr0 #GMPfacility #celltherapymanufacturing #celltherapy #allogeneiccelltherapy

ISPE's ATMP Allogeneic Cell Therapy Guide is here, and our team at CRB is proud of Niranjan Kulkarni for co-authoring the Supply Chain chapter! This Guide is a robust resource with input from several industry experts focusing primarily on allogeneic cell therapies, specifically manufacturing facility development and design. It also outlines common challenges with allogeneic cell therapy facilities, design concepts specific to allogeneic cell therapy facilities, and GMP layout and architectural design development. Learn more about the guide at the link below. #LifeSciences #ATMP #SupplyChain #CellTherapy

I received a number of enquiries regarding the topics for the webinar. We will touch on a number of topics, one interesting topic would be "What other companies are doing digitally for biomanufacturing?", we will use case-studies to discuss this. (Webinar registration link - https://lnkd.in/dCjTj8bC) Let's say, you are a Therapeutic company in Phase 2 Cell Therapy trial who outsources all your clinical manufacturing. How can you customize the MES for your own needs? What are other Cell Therapy companies doing?

ISPE's ATMP Allogeneic Cell Therapy Guide is here, and our team at CRB is proud of Niranjan Kulkarni for co-authoring the Supply Chain chapter! This Guide is a robust resource with input from several industry experts focusing primarily on allogeneic cell therapies, specifically manufacturing facility development and design. It also outlines common challenges with allogeneic cell therapy facilities, design concepts specific to allogeneic cell therapy facilities, and GMP layout and architectural design development. Learn more about the guide at the link below. #LifeSciences #ATMP #SupplyChain #CellTherapy

📢 Calling all ISCT Members! 🇦🇺 Unlock the path to successful cell therapy approval in Australia with the ISCT webinar: "Getting Your Cell Therapy Product Approved: Some Dos and Don'ts." Hosted by experts, including Mat Adams, Glenn Smith and Tony Gill from the Therapeutic Goods Administration (TGA), this event is your guide to mastering the regulatory landscape. 📅 Date: 9th Feb, 2024 🕒 Time: 12:00 - 13:00 AEDT 📍 Where: Online (Members only) Key Learning Objectives: ✅Understand pathways and provisions for Cell Therapy products in Australia. ✅Learn what are the regulator expectations for compliance with relevant standards. ✅Understand which manufacturing principles apply to cell therapies. ✅Learn the dos and don’ts for cell therapy dossier development. See you there! #CellTherapy #ISCTANZ #TGA #ISCT

Navigating the maze of GMP standards in cell therapy manufacturing can feel overwhelming, especially with cutting-edge therapies like CAR T. But guess what? You don’t have to tackle it alone! We’re here to support you on your entire journey. Let’s team up and bring advanced therapeutics to patients faster! 🚀

Navigating the maze of GMP standards in cell therapy manufacturing can feel overwhelming, especially with cutting-edge therapies like CAR T. But guess what? You don’t have to tackle it alone! We’re here to support you on your entire journey. Let’s team up and bring advanced therapeutics to patients faster! 🚀