What defines a superior cell therapy product and how is it accomplished? HemaCare recently carried out an in-depth analysis of a representative sample of fresh leukopak collections from healthy donors. Read more...
Webinar: Ensuring source material consistency and continuity for commercialization of advanced therapies
Join speakers Dominic Clarke of HemaCare, Amy Shaw of Beam Therapeutics, and Christopher Good of Biocair as they discuss the ongoing material sourcing challenges when transitioning from development to clinical and commercial manufacturing scale.
Learn more about HemaCare’s role in commercializing patient cell therapies and how we may be able to assist you on your next project.
Bone marrow-derived cell therapy starting materials are being used to support the development of a wide variety of new cell and gene therapies. However, the process of bringing a cell therapy to clinical adoption can be daunting due to the stringent requirements imposed by regulating agencies and the challenge of identifying a reliable supplier of GMP-compliant starting material. This white paper will discuss these challenges and give considerations for transitioning to GMP-compliant starting materials for product development process.
Get a glimpse of our new facility and learn more about who we are and the products and services we provide in this video.
Managing the complex journey from donor selection to sample collection is critical in ensuring a high-quality final product. Learn what goes into producing mobilized blood products and how HemaCare’s 40+ years of donor management and clinical experience can lead to a high-quality product in this informative infographic.
Learn more about how HemaCare's donor management expertise and years of apheresis experience help find the right balance between purity and yield in your cellular therapeutic.
Join two leaders in cell therapy manufacturing and supply chain strategy - Dominic Clarke (Global Head of Cell Therapy, HemaCare) and David Smith (Head of Innovation and Engineering, Hitachi Chemical Advanced Therapeutics Solutions) as they explain how to improve both the efficiency and flexibility of cell therapy manufacturing processes whilst reducing the challenge presented by inherent variability in cell therapy starting materials.
HemaCare's leukapheresis material powers CAR T cell discovery platform that will support the discovery and development of novel cell and gene-based technologies for one of the largest pharmaceutical companies in the world.
From research to clinical trials, the success of your drug development project relies heavily on quality starting material. Having performed over 250,000 apheresis collections, HemaCare understands the unique needs of our customers while also adhering to cell product manufacturing best practices. With this expertise, we developed the 10 Questions to Ask Your Apheresis Provider guide to help you ask the right questions and be confident that your prospective partner’s goals are aligned with your own.
Cryopreserved Leukopaks Maintain Cell Viability and Functionality: A Solution for Cell Therapy Logistics
Fresh leukopaks maintain good viability and functionality for the first 24 hours of transport. However, beyond 48 hours, the number of viable cells decreases dramatically. When considering global transportation and the cell therapy supply chain, the need for a practical shipping option is crucial. This application note evaluates HemaCare's cryopreserved leukopaks frozen on day 0 compared to fresh leukopaks at 24 hours.
CD34+ Hematopoietic Stem and Progenitor Cells (HSPCs) From Different Tissue Sources for Cell Therapy
One of the major challenges in developing successful therapeutics is lack of access to high-quality starting cellular material. HSPCs are used as precursor material for the ex vivo expansion of genetically manipulated cells for cell therapy. This white paper will discuss effects of various mobilization strategies, functional differences between CD34+ cells derived from bone marrow, cord blood, and mobilized peripheral blood, and factors that can significantly influence potency and downstream impact of cellular therapies.
A case study featuring a European-based cell therapy company where the Lead Technical Scientist discusses how HemaCare met the challenge of obtaining high-quality leukopaks that met specific donor criteria while ensuring functionality of immune cells is not lost during shipment to the United Kingdom.
Cell Therapy Company Rexgenero Utilizes HemaCare’s Bone Marrow Products for Development of their Critical Limb Ischemia Therapeutic
A case study featuring Rexgenero where Dr. de Jong discusses her experience in working with HemaCare products. The company is developing a number of cell-based therapeutics for the treatment of diseases such as peripheral artery disease and critical limb ischemia. During process development, healthy donor material is used as a stand-in for patient material and therefore it’s critical that variability be kept to a minimum.
Regulatory T cells (Treg) are immune cells that help maintain balance in the immune system to prevent the destruction of healthy tissue, leading to inflammation and autoimmune disease. Understanding how Treg cells themselves are suppressed or activated is a major question being studied in current research and the primary goal of Treg focused cell therapy research. This white paper will discuss Tregs role in current research and clinical applications, isolation and cryopreservation best practices, and other factors that can significantly influence potency and downstream impact of cellular therapies.
Precision Immunotherapy Program at Argos Therapeutics Utilizes HemaCare Leukopak Products for their Therapeutic Cell Manufacturing Workflow
A case study featuring Argos Therapeutics where Dr. Miesowicz discusses the challenges in finding raw materials for personalized immunotherapy. Donors are critical to the development process and reliable sourcing can be crucial to positive downstream results. Dr. Miesowicz emphasized that one of the main reasons he chooses HemaCare time and time again is because HemaCare supplies high quality products and goes above and beyond when coordinating development efforts.
Human primary cells are directly derived from the tissue, they are not transformed and non immortalized. Primary cells closely mimic characteristics similar to in vivo conditions – they are nearest to the “real thing”. This infographic is a helpful visual breakdown of the difference between primary cells and cell lines.
A general overview brochure highlighting the main differences between research use only and GMP-compliant starting material for cell and gene therapy.
General overview brochure highlighting HemaCare's research use only products and services.
General overview brochure highlighting HemaCare's GMP-compliant products and services to support global cell therapy from product and process development through commercialization.
Easy-to-follow overview of cell types derived from myeloid cells and highlights of the culture conditions to differentiate each cell.
Easy-to-follow overview of cell types derived from lymphoid cells and highlights of the culture conditions to differentiate each cell.
A listing of publications detailing how HemaCare leukopaks and primary cells were used in cancer research.
Thawing cryopreserved cells properly is crucial to ensure the viability and functionality of the cells. Using good technique and working quickly ensures that a high proportion of the cells survive the procedure.
Neutrophils are a very sensitive cell type and can be easily activated by reagents. Activation of neutrophils is not an all or nothing phenomenon and each function has its own threshold for a response. This protocol provides step-by-step instructions on how to activate neutrophils.
Cells are a valuable resource and replacement is expensive and time consuming. Therefore, freezing and preserving extra fresh cells or cells that are not needed immediately for processing for long-term storage is vitally important.
The preparation of a leukopak prior to performing isolation of PBMCs is crucial to ensure good starting material for your project. This protocol provides step-by-step instructions on how to purify PBMCs from a leukopak.
Thawing cryopreserved cells properly is crucial to the viability and functionality of the cells. Using good technique and working quickly ensures that a high proportion of the cells survive the procedure.
HypoThermosol® is a novel, engineered, optimized hypothermic storage and shipping media product designed to provide maximum storage and shipping stability for biologics at 2-8°C. This protocol discusses how to remove HypoThermosol® if cells were shipped with this media.