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<p class="MsoNormal"><span lang="EN-GB">This document specifies general requirements for the establishment of a fit for purpose purification process of extracellular vesicles (EVs) specifically for </span><span lang="EN-GB" style="mso-fareast-language: JA;">research and development</span><span lang="EN-GB">.</span><span lang="EN-GB" style="mso-fareast-language: JA;"> It includes the selection of the purification method, equipment and validation of the purification process.</span></p>
<p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">This document provides requirements for purification equipment suppliers of EVs as well as requirements for purification equipment users.</span></p>
<p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">This document primarily, but not exclusively, covers EV purification from cell culture supernatants.</span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size: 10.0pt; mso-fareast-language: JA;">NOTE<span style="mso-tab-count: 1;"> </span>International, regional or national regulations or requirements can also apply to specific topics covered in this document.</span></p>
Reģistrācijas numurs (WIID)
89980
Darbības sfēra
<p class="MsoNormal"><span lang="EN-GB">This document specifies general requirements for the establishment of a fit for purpose purification process of extracellular vesicles (EVs) specifically for </span><span lang="EN-GB" style="mso-fareast-language: JA;">research and development</span><span lang="EN-GB">.</span><span lang="EN-GB" style="mso-fareast-language: JA;"> It includes the selection of the purification method, equipment and validation of the purification process.</span></p>
<p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">This document provides requirements for purification equipment suppliers of EVs as well as requirements for purification equipment users.</span></p>
<p class="MsoNormal"><span lang="EN-GB" style="mso-fareast-language: JA;">This document primarily, but not exclusively, covers EV purification from cell culture supernatants.</span></p>
<p class="MsoNormal"><span lang="EN-GB" style="font-size: 10.0pt; mso-fareast-language: JA;">NOTE<span style="mso-tab-count: 1;"> </span>International, regional or national regulations or requirements can also apply to specific topics covered in this document.</span></p>
