{"id":14361,"date":"2018-06-20T13:40:04","date_gmt":"2018-06-20T13:40:04","guid":{"rendered":"https:\/\/www.process.st\/templates\/biosimilars-new-approach\/"},"modified":"2018-06-20T13:40:04","modified_gmt":"2018-06-20T13:40:04","slug":"biosimilars-new-approach","status":"publish","type":"post","link":"https:\/\/www.process.st\/templates\/biosimilars-new-approach\/","title":{"rendered":"Biosimilars new approach"},"content":{"rendered":"
\n

Clearly define all your risks up front <\/h2>\n
\n

Understand environmental hazard challenges other than temperature and how they could affect biosimilarity after interactions with the primary container<\/span><\/p>\n<\/p><\/div>\n<\/section>\n

\n

Understand interactions between multiple hazards <\/h2>\n
\n

How do these interactions impact drug product quality<\/p>\n

    \n
  • Temperature and shock\/vibration to particulate formation<\/li>\n
  • Shock\/vibration and pressure to CCI and sterility<\/li>\n<\/ul><\/div>\n<\/section>\n
    \n

    Consider using simulation studies to conduct drug product operational qualification <\/h2>\n
    \n
      \n
    • Controlled versus uncontrolled environment<\/li>\n
    • Full range of testing hazards in your \u2018design space\u2019<\/li>\n<\/ul><\/div>\n<\/section>\n
      \n

      Write it all down in a validation master plan focused on your cold chain processes <\/h2>\n
      \n
        \n
      • Execute a risk assessment and prepare a mitigation plan for your biosimilar cold chain<\/li>\n
      • Clearly identify hazards other than temperature<\/li>\n
      • Justify your approach for operational qualification and performance qualification<\/li>\n<\/ul><\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"

        Clearly define all your risks up front Understand environmental hazard challenges other than temperature and how they could affect biosimilarity after interactions with the primary container Understand interactions between multiple hazards How do these interactions impact drug product quality Temperature and shock\/vibration to particulate formation Shock\/vibration and pressure to CCI and sterility Consider using simulation […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ep_exclude_from_search":false,"cover_icon_emoji":"","cover_icon_url":"","tasks_count":"4","template_description":"","template_id":"kb3hFoIyBT7SN6GFM_NKQw","task_0":"Clearly define all your risks up front","task_slug_0":"clearly-define-all-your-risks-up-front","task_1":"Understand interactions between multiple hazards","task_slug_1":"understand-interactions-between-multiple-hazards","task_2":"Consider using simulation studies to conduct drug product operational qualification","task_slug_2":"consider-using-simulation-studies-to-conduct-drug-product-operational-qualification","task_3":"Write it all down in a validation master plan focused on your cold chain processes","task_slug_3":"write-it-all-down-in-a-validation-master-plan-focused-on-your-cold-chain-processes","task_4":"","task_slug_4":"","task_5":"","task_slug_5":"","task_6":"","task_slug_6":"","task_7":"","task_slug_7":"","task_8":"","task_slug_8":"","task_9":"","task_slug_9":"","task_10":"","task_slug_10":"","task_11":"","task_slug_11":"","task_12":"","task_slug_12":"","task_13":"","task_slug_13":"","task_14":"","task_slug_14":"","task_15":"","task_slug_15":"","task_16":"","task_slug_16":"","task_17":"","task_slug_17":"","task_18":"","task_slug_18":"","task_19":"","task_slug_19":"","task_20":"","task_slug_20":"","task_21":"","task_slug_21":"","task_22":"","task_slug_22":"","task_23":"","task_slug_23":"","task_24":"","task_slug_24":"","task_25":"","task_slug_25":"","task_26":"","task_slug_26":"","task_27":"","task_slug_27":"","task_28":"","task_slug_28":"","task_29":"","task_slug_29":"","task_30":"","task_slug_30":"","task_31":"","task_slug_31":"","task_32":"","task_slug_32":"","task_33":"","task_slug_33":"","task_34":"","task_slug_34":"","task_35":"","task_slug_35":"","task_36":"","task_slug_36":"","task_37":"","task_slug_37":"","task_38":"","task_slug_38":"","task_39":"","task_slug_39":"","task_40":"","task_slug_40":"","task_41":"","task_slug_41":"","task_42":"","task_slug_42":"","task_43":"","task_slug_43":"","task_44":"","task_slug_44":"","task_45":"","task_slug_45":"","task_46":"","task_slug_46":"","task_47":"","task_slug_47":"","task_48":"","task_slug_48":"","task_49":"","task_slug_49":"","task_50":"","task_slug_50":"","task_51":"","task_slug_51":"","task_52":"","task_slug_52":"","task_53":"","task_slug_53":"","task_54":"","task_slug_54":"","task_55":"","task_slug_55":"","task_56":"","task_slug_56":"","task_57":"","task_slug_57":"","task_58":"","task_slug_58":"","task_59":"","task_slug_59":"","task_60":"","task_slug_60":"","task_61":"","task_slug_61":"","task_62":"","task_slug_62":"","task_63":"","task_slug_63":"","task_64":"","task_slug_64":"","task_65":"","task_slug_65":"","task_66":"","task_slug_66":"","task_67":"","task_slug_67":"","task_68":"","task_slug_68":"","task_69":"","task_slug_69":"","task_70":"","task_slug_70":"","task_71":"","task_slug_71":"","task_72":"","task_slug_72":"","task_73":"","task_slug_73":"","task_74":"","task_slug_74":"","task_75":"","task_slug_75":"","task_76":"","task_slug_76":"","task_77":"","task_slug_77":"","task_78":"","task_slug_78":"","task_79":"","task_slug_79":"","task_80":"","task_slug_80":"","task_81":"","task_slug_81":"","task_82":"","task_slug_82":"","task_83":"","task_slug_83":"","task_84":"","task_slug_84":"","task_85":"","task_slug_85":"","task_86":"","task_slug_86":"","task_87":"","task_slug_87":"","task_88":"","task_slug_88":"","task_89":"","task_slug_89":"","task_90":"","task_slug_90":"","task_91":"","task_slug_91":"","task_92":"","task_slug_92":"","task_93":"","task_slug_93":"","task_94":"","task_slug_94":"","task_95":"","task_slug_95":"","task_96":"","task_slug_96":"","task_97":"","task_slug_97":"","task_98":"","task_slug_98":"","task_99":"","task_slug_99":"","footnotes":""},"categories":[7],"tags":[],"class_list":["post-14361","post","type-post","status-publish","format-standard","hentry","category-miscellaneous"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/posts\/14361","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/comments?post=14361"}],"version-history":[{"count":0,"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/posts\/14361\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/media?parent=14361"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/categories?post=14361"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.process.st\/templates\/wp-json\/wp\/v2\/tags?post=14361"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}