Hematopoietic Cell Therapy
The field of hematology has been at the forefront of regenerative medicine for more than six decades. Emerging from the pioneering bone marrow transplants of the 1950s and 60s, hematopoietic stem cell transplantation (HSCT) has since become the standard of care for numerous hematological disorders and malignancies. The application of CD34+ cells in translational workflows continues to expand, bringing new possibilities for curative cell and gene therapies.
The emergence of FDA-approved autologous gene therapies such as Casgevy and Lyfgenia have signaled a new era for hematopoietic cell therapy, and the field continues to push beyond conventional transplantation toward increasingly precise, scalable, and transformative therapeutic approaches. High manufacturing costs and complex logistics remain key challenges, driving researchers to pursue innovative strategies such as ex vivo-expanded universal donor cells, hypoimmune induced pluripotent stem cell (iPSC)-derived hematopoietic stem and progenitor cells (HSPCs), and even in vivo gene editing (the goal being to eliminate the need for transplantation entirely). The realization of these next-generation therapies will depend on the advancement of scalable gene-editing workflows, reliable cGMP-compliant media, robust ex vivo expansion methods, and potency assays that provide meaningful measures of HSPC function.
The scientific resources below have been curated to support you through the key stages of hematopoietic cell therapy development and manufacturing, including sourcing, expanding, and gene-editing HSPCs, tools and assay selection, regulatory compliance pathway navigation, and more.
NEW! Free On-Demand Course: Application of HSPCs in Cell Therapy
From the fundamentals of hematological disease progression and hematopoietic cell therapy products, to key workflow and compliance considerations, you鈥檒l learn best practices for applying HSPCs in cell therapy development and gain insight into the unique challenges and opportunities. Whether you're already working with HSPCs in translational workflows or just getting started, this self-paced virtual course will help move your HSPC-based cell therapy closer to the clinic.
Register Now >Building Robust, Compliant CD34+ Cell Culture Workflows
Webinar: High-Quality Mobilized Leukopaks to Enhance Your Cell and Gene Therapy Research and Development
Learn how to use mobilized leukopaks alongside the latest technologies to isolate, expand, differentiate, gene edit, and analyze CD34+ cells.
Webinar: Removing Animal Components from Your HSC Workflow
Learn how animal origin-free hematopoietic stem cell (HSC) reagents can support optimized cell quality and reproducibility throughout your workflow, ultimately easing your path to the clinic.
Optimizing Gene Editing of HSPCs
Webinar: Optimizing CD34+ Cell Genome Editing for Efficiency and HSPC Maintenance
Learn tips and tricks for optimizing genome editing conditions for CD34+ cells, maintaining human HSPC function, and evaluating long-term editing effects. You can also find the accompanying Q&A article for the webinar here.
Protocol: Gene Editing Human CD34+ HSPCs with the 颁别濒濒笔辞谤别鈩 Transfection System
Achieve efficient gene editing of HSPCs with 颁别濒濒笔辞谤别鈩. When combined with 厂迟别尘厂辫补苍鈩 media and supplements, this innovative mechanoporation-based technology enables efficient and precise gene editing in primary human CD34+ HSPCs while preserving cell phenotype and function.
Developing a Potency Testing Strategy for Hematopoietic Cell Therapy Products
Webinar: Implementing the CFU Assay as a Potency Assay for Hematopoietic Cell Therapy Products (HCTPs)
Join Dr. Colin Hammond to learn about the regulatory guidance around the potency testing of HCTPs. You鈥檒l explore how to validate the CFU assay as a potency assay that can be integrated into cell therapy manufacturing workflows.
Q & A: Evaluating Hematopoietic Cell Therapy Product Potency Using the CFU Assay
Get expert answers to questions on regulatory guidance for potency testing, integrating the CFU assay into cell therapy manufacturing workflows, and more.
Regulatory Compliance, Commercialization
Webinar: Key Regulatory Considerations for Moving Your Cell Therapy Research to the Clinic
Learn about crucial regulatory strategies for enhancing clinical candidate success, covering the latest developments and best practices in materials qualification and supplier partnerships. You can also find the accompanying Q&A article for the webinar here.
On-Demand Course: Ancillary Materials
Learn about the translation pathway for cell and gene therapies, and the ancillary material qualification process in this free, self-paced virtual course.
Services to Support and Accelerate Your Hematopoietic Cell Therapy Research and Development
Expert Services for Cell Therapy Development, Tailored to Your Needs
Explore how our Services for Cell Therapy team can help you qualify ancillary materials for use in cell therapy workflows by providing regulatory support, customized solutions, and quality documentation.
Partner with Contract Assay Services to Obtain Timely and Relevant HSPC Data for Your Studies
Gain the technical expertise of our in-house scientists and the support you need to advance your research toward the clinic. Explore our assay services for evaluating HSPC renewal, expansion, and differentiation, including both in vitro assays and in vivo engraftment and mobilization assays.
