{"id":642955,"date":"2024-11-06T01:31:04","date_gmt":"2024-11-06T01:31:04","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-ts-20399-22018\/"},"modified":"2024-11-06T01:31:04","modified_gmt":"2024-11-06T01:31:04","slug":"iso-ts-20399-22018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-ts-20399-22018\/","title":{"rendered":"ISO\/TS 20399-2:2018"},"content":{"rendered":"<p>This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation.<\/p>\n<p>This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells.<\/p>\n<p>The AMs described in this document include those of biological origin [e.g. sera, media (including media additives), growth factors, and monoclonal antibodies] and chemical origin. This document does not address dimethyl sulfoxide (DMSO) for cryopreservation, beads, scaffolds, feeder cells, apparatus and instruments, or additives used post bioprocessing.<\/p>\n<p>This document does not cover the selection, assessment or control of starting materials and excipients.<\/p>\n<p>NOTE       International, regional or national regulations or requirements can also apply to specific topics covered in this document.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Biotechnology \u2014 Ancillary materials present during the production of cellular therapeutic products \u2014 Part 2: Best practice guidance for ancillary material suppliers<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/iso\/\"><b>ISO<\/b><\/a><\/td>\n<td>2018-11<\/td>\n<td>18<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":642967,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[119,2634],"product_tag":[],"class_list":{"0":"post-642955","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-07-080","7":"product_cat-iso","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/642955","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/642967"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=642955"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=642955"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=642955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}