{"id":291245,"date":"2024-10-19T19:46:28","date_gmt":"2024-10-19T19:46:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iso-ts-20399-12018\/"},"modified":"2024-10-25T16:48:01","modified_gmt":"2024-10-25T16:48:01","slug":"bsi-pd-iso-ts-20399-12018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iso-ts-20399-12018\/","title":{"rendered":"BSI PD ISO\/TS 20399-1:2018"},"content":{"rendered":"

This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.<\/p>\n

This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.<\/p>\n

This document does not cover the selection, assessment or control of starting materials and excipients.<\/p>\n

\n

NOTE<\/b> International, regional or national regulations or requirements can also apply to specific topics covered in this document.<\/p>\n<\/blockquote>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 Abbreviated terms
5 Considerations
5.1 General considerations
5.2 Animal-derived components of AM
5.2.1 General
5.2.2 Levels of ADCF <\/td>\n<\/tr>\n
14<\/td>\n5.2.3 Key considerations in the use of animal-derived components
5.2.4 Viral inactivation
5.3 Mutual responsibilities for AMs <\/td>\n<\/tr>\n
15<\/td>\n5.4 Example workflow <\/td>\n<\/tr>\n
16<\/td>\n6 Ancillary material requirements
6.1 Quality management system
6.2 Information on ancillary material products and materials used to produce ancillary materials <\/td>\n<\/tr>\n
17<\/td>\nAnnex A (informative) Example of workflow from AM supplier to AM user <\/td>\n<\/tr>\n
18<\/td>\nAnnex B (informative) Information on AM products and materials used to produce AM <\/td>\n<\/tr>\n
20<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Biotechnology. Ancillary materials present during the production of cellular therapeutic products – General requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2019<\/td>\n22<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":291249,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-291245","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\/291245","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\/291249"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=291245"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=291245"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=291245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}