What are GMP Cells and Tissues
Good Manufacturing Practices (GMP) is a system that ensures cellular material is consistently collected and processed following the guidelines set by government agencies, such as the FDA and EMA, who are responsible for ensuring the quality, efficacy, and safety of pharmaceutical products. HemaCare’s GMP-compliant cells and tissues (GMPrime™ products) are collected in our FDA-registered, GMP-compliant donor center and processed within a cleanroom environment. GMPrime products are collected and processed utilizing the most stringent quality standards, subjected to an extensive quality review, and supplied to customers with supporting documentation during batch release.
Why Use GMP Cells and Tissues
High-quality research use only (RUO) products, HemaPrime™ cells and tissues, provide the flexibility to support early drug discovery and pre-clinical evaluations. However, where all successful pre-clinical candidates will eventually need to abide by GMP regulations and be processed within a GMP-qualified cleanroom environment before translation to the clinic, scientists often prefer to use HemaCare’s GMP-compliant cells during all stages of their research in order to ensure the safety and consistency of the products.
Prior to translating a therapy to the clinic, manufacturers must guarantee a safe, pure, and effective product. Therefore, manufacturers must ensure that all aspects of the production process are validated and thoroughly documented, as well as make certain that the final product is free from contamination and meets the established quality standards. All GMP cells and tissues are subject to rigorous quality system oversight and meet all regulatory standards required by law.
How Are GMPrime Cells and Tissues Collected?
The difference between a RUO and GMP-compliant product should never be one of quality or performance. Rather, at HemaCare, it is the extensive quality review and documentation that makes it GMP compliant. GMPrime cells and tissues are collected and processed utilizing the already streamlined procedures, methods, and quality standards already employed with our HemaPrime research use products within our FDA-registered, GMP-compliant donor center and processed within a cleanroom environment.