Ehdotuksen tiedot

This document specifies requirements for the production and quality control of immunomagnetic beads. This document also gives general quality attributes for immunomagnetic beads, together with common methods for evaluating these quality attributes for end-use. This document is applicable to the research and development of immunomagnetic beads, and to the application field of immunomagnetic beads, e.g., cell sorting, protein purification, and microbial separation. NOTE For manufacturing of cell-based therapeutic products, users can refer to applicable standards such as ISO 20399 [1].