{"id":291250,"date":"2024-10-19T19:46:29","date_gmt":"2024-10-19T19:46:29","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iso-ts-20399-22018\/"},"modified":"2024-10-25T16:48:04","modified_gmt":"2024-10-25T16:48:04","slug":"bsi-pd-iso-ts-20399-22018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iso-ts-20399-22018\/","title":{"rendered":"BSI PD 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<blockquote>\n<p>NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.<\/p>\n<\/blockquote>\n<h4>PDF Catalog<\/h4>\n<table border=\"1px\" class=\"des-table\">\n<tr>\n<th>PDF Pages<\/th>\n<th>PDF Title<\/th>\n<\/tr>\n<tr>\n<td><b>2<b><\/td>\n<td>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>7<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>1 Scope <br \/> 2 Normative references <br \/> 3 Terms and definitions <br \/> 4 Abbreviated terms  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>5 General considerations  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>6 AM characteristics and quality attributes <br \/> 6.1 AM components, identity and purity <br \/> 6.1.1 General <br \/> 6.1.2 Identity and quantity of component(s) <br \/> 6.1.3 Purity\/impurity <br \/> 6.1.4 Lot-to-lot consistency for AMs containing proprietary components  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>6.2 AM storage and stability <br \/> 6.2.1 General <br \/> 6.2.2 Storage conditions <br \/> 6.2.3 Stability and expiration dating  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>7 AM manufacturing and biosafety <br \/> 7.1 Quality management system <br \/> 7.2 Manufacturing process <br \/> 7.3 Container and closure systems  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>7.4 Animal- and human-derived materials <br \/> 7.5 Safety to cells and humans <br \/> 8 AM performance <br \/> 8.1 General  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>8.2 Performance assay <br \/> 8.2.1 General <br \/> 8.2.2 AMs that support cell survival and function <br \/> 8.2.3 AMs that are intended to promote specific cell functions <br \/> 8.3 Cells used for performance assays  <\/td>\n<\/tr>\n<tr>\n<td><b>16<b><\/td>\n<td>8.4 Performance assay results <br \/> 9 AM documentation <br \/> 9.1 General <br \/> 9.2 \u200bCertificate of analysis (CoA)  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>9.3 Additional certificates <br \/> 9.3.1 \u200bCertificate of origin (CoO) <br \/> 9.3.2 \u200bCertificate of compliance (CoC) <br \/> 9.3.3 Certificate of irradiation (CoI) <br \/> 9.4 Other items  <\/td>\n<\/tr>\n<tr>\n<td><b>18<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Biotechnology. Ancillary materials present during the production of cellular therapeutic products &#8211; Best practice guidance for ancillary material suppliers<\/b><\/p>\n<table class=\"shortdes-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\/bsi\/\"><b>BSI<\/b><\/a><\/td>\n<td>2018<\/td>\n<td>20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":291254,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-291250","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/291250","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\/291254"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=291250"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=291250"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=291250"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}