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<p>This document specifies minimum requirements for the production and quality control of immunomagnetic beads.</p>
<p>This document also describes general quality attributes for immunomagnetic beads as well as common methods for evaluating quality attributes.</p>
<p>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.</p>
<p>This document is applicable to all entities engaged in the production, testing, or application of immunomagnetic beads for manufacturing, research and development purposes.</p>
<p>NOTE For manufacturing of therapeutic products, cell-based products, users can refer to applicable GMP requirements and standards such as ISO 20399.</p>
Reģistrācijas numurs (WIID)
91510
Darbības sfēra
<p>This document specifies minimum requirements for the production and quality control of immunomagnetic beads.</p>
<p>This document also describes general quality attributes for immunomagnetic beads as well as common methods for evaluating quality attributes.</p>
<p>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.</p>
<p>This document is applicable to all entities engaged in the production, testing, or application of immunomagnetic beads for manufacturing, research and development purposes.</p>
<p>NOTE For manufacturing of therapeutic products, cell-based products, users can refer to applicable GMP requirements and standards such as ISO 20399.</p>
