CellBri’s Post

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?

This Guide focuses primarily on allogeneic cell therapies, specifically manufacturing facility development and design. Allogeneic cell therapies have unique challenges due to the small manufacturing scale, limitations in scale-up, the need to manufacture multiple lots of products concurrently, and the need for flexibility to accommodate a varied and evolving product portfolio. Read more about the ATMPs - Allogeneic Cell Therapy guide: https://hubs.la/Q02ln8zq0 #ISPE #atmp #allogenic

In this on-demand webinar, Dr. Colin Hammond from STEMCELL Technologies discusses some of the regulatory guidance around hematopoietic cell therapy products, as well as how to validate the CFU assay as a potency assay that can be integrated into cell therapy manufacturing workflows. Watch it now: https://lnkd.in/gswDAbQZ

Ultimately the field needs to have innovation in cell manufacturing technology to promote consistency and improve robustness such that large batch sizes can be achieved per single manufacturing unit to promote consistency and drive costs downward. Before that can occur, many clinical batches are needed to advance the programs to clinic by leveraging on experience with platform technologies and by standardizing processes to allow more timely access to promising new therapies for patients who need them.

Great video by Catalent Pharma Solutions on how #ATMPs work. Hataali provides the platform for the clinical stage, manufacturing stage and even cell logistics services. Visit www.hataali.com and see how we can help optimise your operations!

B-Xpander™ - Unleash the Power of B Cell Expansion https://lnkd.in/d-ihTakZ B-Xpander™ is a potent enhanced Multimeric human CD40L cytokine, for B cell activation, B cell expansion (proliferation) and cell therapy applications. In-house production using a proprietary protocol and a characterized and certified CHO cell line allows the supply of the most active Multimeric human CD40L proteins in GMP-like format.

Our Head of Analytical Development & QC Alice Lin recently joined a roundtable discussion on autologous C&G at the Advanced Therapeutics hubXchange. Alice discussed the challenges and best practices associated with the development of cell therapies. It is critical for industry professionals to delve deep into the intricacies of this research to further the mission of bringing these life-altering treatments to patients. Learn more about the event here: https://lnkd.in/eQAUQU7Y #WomenInLeadership #HealthcareInnovation

Don't Fall Behind the Potency Assay Revolution 🚀 ❗ ❗ In the ever-evolving landscape of cell therapy ⚗ , the need for robust and standardized potency assays has become paramount to ensuring the efficacy and safety of these groundbreaking therapies. To stay at the forefront of this transformative field, don't miss the opportunity to attend the Cell Therapy Potency Assay Summit in Boston from March 19th to March 21st, 2024. ❗ ❗ As the FDA's recent requirement for further potency assay data for Mesoblast's Ryoncil product demonstrates, the importance of standardized potency assays is undeniable. This collaboration with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) highlights the growing urgency to establish consistent and reliable potency assessment methods across the cell therapy industry. The Cell Therapy Potency Assay Summit is your chance to immerse yourself in the cutting edge of potency assay innovations and connect with industry experts who are shaping the future of this critical field. Here's what you can expect: · Expert Insights: Gain valuable insights from leading scientists 👨🔬 , clinicians 👩🔬 , and industry professionals on the latest potency assay technologies 💻 and methodologies such as potency assay matrix development or viral vector potency assays. · Regulatory Landscape: Delve into the regulatory complexities of cell therapy potency assays in person with the regulatory body Health Canada where you will learn exactly what regulatory bodies are looking for in cell therapy potency assays and how to align those assays with their expectations. ✔ ✔ · Collaborative Innovation: Network with peers and engage in thought-provoking discussions to foster collaboration and accelerate the development of innovative potency assay solutions where you can learn topics like: standardising work when dealing with external partners, how to avoid delays caused by tech transfer, how to link potency to clinical efficacy and more…! 👨⚕️ 👩⚕️ Don't let this opportunity pass you by. Register for the Cell Therapy Potency Assay Summit today ❗ and become a driving force behind the advancement of the cell therapy industry by paving the way with sound, standardised potency assays. 🕙 If you would like to learn more then please reach out or find more details on our website: https://lnkd.in/etmNZHm3 #celltherapy #PotencyAssay #Summit #Boston #FDA #Ryoncil #Mesoblast #Innovation #Standardization #FutureOfMedicine

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

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