Halo Labs’ Post

The development of chimeric antigen receptor (CAR) T-cell therapy for hematological malignancies is a promising therapeutic advancement in the cell and gene therapies. Our latest article talks about the heightened interest in applying CAR T-cell therapy to various hematologic malignancies over the last decade. https://bit.ly/3s2rlGH #cartcelltherapy #cartcell #cartcells #celltherapy #hematology #genetherapy #pharmaceutical #pharma #drugdevelopment #clinicaltrials #drugsafety #pharmacovigilance 

🌟 Exploring the Future of #RareDisease Treatment: Cell and Gene Therapies Market 🌟 DelveInsight Business Research LLP's latest report dives into the transformative landscape of Cell and Gene Therapies in Rare Disorders Market. With groundbreaking innovations in gene editing, cell-based treatments, and personalized #medicine, this report sheds light on emerging therapies aimed at revolutionizing rare disease management. The leading Cell and Gene Therapies in Rare Disorders Companies such as Pfizer, Sangamo Therapeutics, Inc., Roche (Spark Therapeutics, Inc.), Freeline Therapeutics, 4D Molecular Therapeutics, Astellas Pharma Gene Therapies, Actus Therapeutics (Acquired by Bayer), GenSight Biologics, Coave Therapeutics, Johnson & Johnson/MeiraGTx, Applied Genetic Technologies Corporation, Nanoscope Therapeutics Inc. jCyte, Inc., ReNeuron Group Plc, REGENXBIO, Amicus Therapeutics, Sarepta Therapeutics, Capricor Therapeutics, Inc./Nippon Shinyaku, BrainStorm Inc. Cell Therapeutics, CRISPR Therapeutics/Vertex Pharmaceuticals, Editas Medicine, Krystal Biotech, Inc., Abeona Therapeutics, Castle Creek Biosciences, Inc., Holostem Terapie Avanzate S.r.l., RHEACELL GmbH & Co. KG, Ishin Pharma, Anterogen, Ultragenyx Pharmaceutical, and others. 🔬 Uncover how novel therapies are opening doors to improved outcomes and hope for patients worldwide @ https://lnkd.in/djeg783R #CellAndGeneTherapy #RareDisorders #GeneTherapy #MarketResearch #HealthcareInnovation #DelveInsight

Synergies between automated cell expansion systems and real-time analyzers creates a powerful combination for monitoring and optimizing cell expansion processes, transforming cell and gene therapy manufacturing to provide improved scalability, reproducibility, and tighter process controls. See how 908 Devices and Terumo BCT are collaborating to do just that. #celltherapy #manufacturing #processdevelopment

An insightful post shared below:

“One of the key things that has delayed a fair number of (cell and gene therapy) approvals over the course of time has been issues related to potency”. This is a quote from a highly respected FDA Director made during an all-day working session organized by the Alliance for Regenerative Medicine (ARM) and the American Society of Gene & Cell Therapy (#ASGCT) in October 2022. An industry representative further added “At the end of the day, we’re all here because we think potency assays could be improved both by us and by the regulators. We understand that they are a hurdle to getting these drugs rapidly to patients, and we ultimately serve the patient”. Almost 2 years have passed since then. Has anyone in the meantime identified solution that go beyond mere individual analytical measures, and instead give a more holistic view on the potency of a cell therapy (in a form factor that can be used during R&D as well as during routine manufacturing QC release)? Looking forward to hearing your thoughts on this, Benjamin McLeod, Shivali Joshi, Qiang Qin, Van Hoang, Zhu Pirot, Shibani Mitra-Kaushik, Yves Peeraer, Tim Desmet. Want to read more: https://lnkd.in/eDbjuRpj imec.xpand #ATMP #potency #GeneTherapy #HealthTech #celltherapy #CARTcell #biotechnology #innovation #science

The challenge of potency in cell and gene therapy is a critical bottleneck in bringing these life-changing treatments to patients. Benoit Devogelaere from imec.xpand highlights the ongoing discussion and the urgent need for innovative solutions in this space. A thought-provoking post for anyone involved in CAR-T and cell therapy development.

The promise of CAR-T as a life-changing treatment is becoming undeniable. Critical to understanding and predicting the clinical effectiveness of engineered CAR-T constructs is our ability to obtain a true measure of cell potency. Benoit Devogelaere of imec.xpand takes a dive into ongoing discussions and indicates a clear need for innovation in this area. A very interesting read!

Are you designing an early-phase clinical trial for your cell & gene therapy (CGT) product? Unsure of how to approach the trial design? Early phase trial designs for CGT products depend on the product's distinctive features, previous clinical experience and manufacturing logistics. Inevitably, these are significantly different (and may be more complex） than those of small molecules. It is important for sponsors to consider clinical safety issues, preclinical issues, and CMC related issues for CGT products. Read our blog that covers the key considerations when designing early-phase clinical trials for CGT products https://lnkd.in/dRzXEzcx Discuss your regulatory requirements for designing CGT clinical trials 🤝 Meet us at BIO International 2024: https://lnkd.in/gJt7Vxwv 🤝 Meet us at DIA Global 2024: https://lnkd.in/grrwWGU6 #cell #gene #therapy #clinical #trial #regulatory #BIO2024 #DIAGlobal #pharma #biologic #CMC #preclinical #safety

Nucleus Biologics Launches NB-KUL™ DF: A DMSO-Free, Chemically-Defined Cryomedia Revolutionizing Cell and Gene Therapy Cryopreservation - https://lnkd.in/g5DU7MGg  Nucleus Biologics, a leading provider of cell culture and bioprocessing solutions for the cell and gene therapy (CGT) industry, has launched NB-KUL DF, a DMSO-free, chemically-defined cryomedia set to redefine cryopreservation standards. Designed for CGT manufacturers, NB-KUL DF matches DMSO-based media performance and outperforms other DMSO-free options in cell viability, recovery, and expansion. While DMSO is an effective cryoprotectant, its toxicity compromises cell viability, can cause patient issues, and requires complex wash steps, adding cost and variability. NB-KUL DF eliminates these issues, offering a DMSO-free solution that preserves cell integrity, eliminates the potential for patient side effects, and simplifies cryopreservation making it ideal for T cells, MSCs, and other sensitive cell types used in CGT. Key Benefits of NB-KUL™ DF: - Supports Viability and Recovery in Multiple Cell Types: NB-KUL DF ensures higher post-thaw viability and recovery than competitive cryomedia, optimizing therapeutic cell preservation for better clinical outcomes. - Enhanced Expansion: Supports superior cell expansion when compared to competitive medias, meeting the demands of large-scale CGT manufacturing. - DMSO-Free: Eliminating DMSO reduces cytotoxicity, protecting cells and patients, especially in high-dose or immunocompromised therapies. - Streamlined Workflow: Simplifies processes by removing the need for DMSO washing steps, reducing cell loss, variability, time, and costs. #celltherapy #genetherapy #research #ryopreservation David De Leonardis Brad Taylor

Cell and Gene Therapies in Rare Disorders Market Size in the 7MM was estimated to be nearly USD 2,000 Million in 2023 DelveInsight Business Research LLP brings you the latest insights on the "Cell and Gene Therapies in Rare Disorders Market"! Explore how cutting-edge advancements in gene editing, cell therapies, and personalized medicine are revolutionizing the treatment landscape for rare disorders. 💡 The leading Cell and Gene Therapies in Rare Disorder Companies such as Pfizer, Sangamo Therapeutics, Inc., Roche Freeline Therapeutics, 4D Molecular Therapeutics, Spark Therapeutics, Inc. (acquired by Roche), Astellas Pharma Gene Therapies, Actus Therapeutics (Acquired by Bayer), GenSight Biologics, Coave Therapeutics, Johnson & Johnson/MeiraGTx, Applied Genetic Technologies Corporation, Nanoscope Therapeutics Inc., Ocugen, jCyte, Inc., ReNeuron Group Plc, REGENXBIO, Amicus Therapeutics, Sarepta Therapeutics, Capricor Therapeutics, Inc./Nippon Shinyaku, Brainstorm Cell Therapeutics, CRISPR Therapeutics/Vertex Pharmaceuticals, Editas Medicine, Krystal Biotech, Inc., Abeona Therapeutics, Castle Creek Biosciences, Inc. Holostem S.r.l. Terapie Avanzate S.r.l., RHEACELL GmbH & Co. KG, Ishin Pharma, Anterogen, Ultragenyx Pharmaceutical and others. 📌 Read the full report here @ https://lnkd.in/djeg783R #CellAndGeneTherapies #RareDiseases #PrecisionMedicine #GeneTherapy #Biotechnology #RareDisorders #InnovationInHealthcare #DelveInsight #MarketResearch #PharmaTrends