High-Quality Starting Material
HemaCare’s tissue collection expertise integrates a comprehensive quality system based on stringent regulatory requirements and industry best practices. Whether it is leukapheresis-derived starting material (leukopak), bone marrow, or cord blood, HemaCare provides customers with validated, high-quality starting material.
Not all projects share the same requirements. HemaCare routinely works with customers to optimize their collection protocols and perform tissue collections that meet specific parameters. HemaCare is happy to assist scientists in choosing the most suitable donor selection criteria, mobilization method, or cold chain solutions to meet their project requirements. Whether it is for research and development, a clinical trial, or collection for an FDA-approved therapy, HemaCare’s tissue sample collection expertise can be your advantage. Here are just a few of the customized services we offer:
- Tissue and cell type request
- Healthy and disease-state donor selection criteria
- Stem cell mobilization process
- Cell collection method
- Cell isolation method
- Preservation Media
- Packaging and shipping requirements
Optimal Apheresis Collections
With an exciting number of new cell therapies progressing towards clinical trials, optimizing the quality of cell therapy starting materials has become an essential component to cell therapy development success. Cell collection methods and apheresis techniques greatly impact the quality and therapeutic potency of starting material. With 40 years of experience, HemaCare has performed over 300,000 apheresis procedures. Their qualified collection methods provide high-quality leukapheresis material, demonstrating high purity prior to any further cell purification or isolation. Optimized collections are ideal for autologous process development work and starting material for allogeneic cell therapies. All collections from healthy donors are performed within HemaCare’s FDA registered, GMP-compliant collection center.
GMP-compliant Starting Material
Following GMP and GTP collection guidelines is often necessary for both pre-clinical and clinical development. Developing standardized protocols for tissue collection and handling will minimize product variability and protect downstream efficacy. Optimizing a production workflow helps ensure an effective and reliable product. HemaCare provides GMP leukopaks and, coming soon, will be providing GMP Bone Marrow Aspirates that support clinical trials and commercialized therapies, globally.