From BENCH to BEDSIDE, which product line is right for your project?
HemaPrime™ Cells and Tissues
Utilizing quality materials at the inception of the drug discovery process can significantly impact the success and speed of downstream steps leading to commercialization. HemaCare’s research use only (RUO) product line, HemaPrime, provides customers just that – high-quality, well-characterized cellular materials to expedite your drug discovery and process development goals.
HemaPrime products are held to the same top-quality standards and many follow the same protocols as their GMPrime counterparts, so when the need for GMP-compliant materials arises transferring your process is streamlined. Certainly, RUO products do not go through the intensive documentation review required for GMP compliance however, this provides both a cost and processing flexibility benefit for your development needs.
Available HemaPrime Product Categories:
GMPrime™ Cells and Tissues
HemaCare’s GMP-compliant product line, GMPrime, provides customers with high-quality, well-characterized cellular material that includes the necessary documentation to comply with FDA and EMA guidelines. Collection is performed in an FDA-registered, GMP-compliant donor center and processing and isolation are performed within a cleanroom environment. Each GMPrime product is subjected to an extensive quality review and is provided with supporting documentation during batch release.
HemaCare quality systems ensure that the transition from HemaPrime to GMPrime biological material is seamless. With an experienced quality team and optimized methods in place from the start, the process is streamlined, supporting cost efficiency and ease of scale-up/scale-out, thus ensuring products with minimal variability.
Available GMPrime Products:
Defining the Difference: HemaPrime vs GMPrime
Because Prime Means Quality
We stand by our products and believe the difference between a HemaPrime or GMPrime product should never be one of quality or performance. Even though a level of QA oversight separates the two, the processes and procedures employed as well as the care we take in ensuring consistency of performance is a cornerstone of both product lines.
We developed our GMPrime products utilizing the rigorous quality standards already employed with HemaCare’s HemaPrime products. This comprehensive quality system follows current GMP/GTP guidelines (21 CFR 210, 211, 606, 1271 and 21 CFR part 11 and part 58).
Whether your current or future needs are RUO or GMP-compliant cellular material, HemaPrime and GMPrime have you covered. HemaCare’s process development services, combined with a flexible production environment, optimized process flow, and robust quality system enables HemaCare to address your current and future starting material needs.
And Quality Begins with the Donor
Quality systems and compliance ensure our procedures and practices for creating products are consistent, safe, and employ best practices for the ultimate in product consistency. However, the product story truly begins with our amazing donors. With over 40 years of donor management experience, we know how to schedule, nurture, and advise donors to ensure successful and safe donations. HemaCare’s large donor database makes it easier to match donor profiles to specific RUO or GMP project requirements. A robust, recallable donor database provides the ability to reserve donors and reduces variability for scientists developing cell-based therapies. Furthermore, with over 250 years of combined clinical expertise, our staff can optimize collections to provide the perfect balance of purity and yield in your apheresis starting material.
Why Prime? Because Prime is Quality and Quality Begins with Our Donors!
“The quality of precursor material is absolutely essential since it will determine the quality of the downstream product. You need to have high-quality material going in because it will affect a lot of other parameters downstream.”
– Head of T Cell Processing, Global Pharmaceutical Company