{"id":16904,"date":"2024-08-30T14:07:32","date_gmt":"2024-08-30T14:07:32","guid":{"rendered":"https:\/\/kanboapp.com\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/"},"modified":"2024-08-30T14:07:32","modified_gmt":"2024-08-30T14:07:32","slug":"advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing","status":"publish","type":"page","link":"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/","title":{"rendered":"Advancing Global Drug Development: Embracing Process Management Techniques in Downstream Pharmaceutical Processing"},"content":{"rendered":"<style> @media(min-width:1728px) { .tytulek{font-size:45px!important;margin-right:auto!important;margin-left:auto!important;max-width: 1200px!important;} .sekcja-tekst { margin-left: 40px!important; margin-right: 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1200px!important;} .sekcja-tekst { margin-left: 16px!important; margin-right: 16px!important;}  .artykul{margin-bottom:80px!important; margin-top:30px!important;} .menu-lewe a:hover { background:#E9F4FE!important; font-weight:600!important; font-size:16px!important; cursor:pointer!important; } .menu-lewe a { background:#FAFAFA; padding:10px 16px; border-radius: 10px; display: inline-block; outline: none; color:#0C3658!important; font-weight:600!important; font-size:16px!important; }  .kolumna-tekst{flex-basis:100%!important;} .naglowek-duzy {margin-bottom:40px!important; margin-top: 40px!important; font-size:25px!important; font-style:normal; font-weight:700!important; letter-spacing:-0.02em!important; line-height:1.2!important;} .naglowek-maly {margin-bottom:20px!important; font-size:16px!important; font-style:normal; font-weight:700!important; letter-spacing:-0.02em!important; line-height:1.2!important;} .naglowek-start {margin-bottom:40px!important; margin-top: 0px!important; font-size:19px!important; font-style:normal; font-weight:700!important; letter-spacing:-0.02em!important; line-height:1.2!important;} .tekst-para {font-size:16px!important;} .spis { display:none!important; } } .link a:hover { text-decoration:underline!important; } .banner { margin-top:80px; margin-bottom:80px; } .jazda { position:sticky!important; top: 185px; overflow: auto; max-height: 70vh; }  .fobrazek { margin-bottom: -40px!important; } .sekcja5-przycisk a:hover { background: linear-gradient(0deg, rgba(0, 0, 0, 0.15), rgba(0, 0, 0, 0.15)), #ED4B9E!important; }  .sekcja5-przycisk a:focus { background: linear-gradient(0deg, rgba(0, 0, 0, 0.15), rgba(0, 0, 0, 0.15)), #ED4B9E!important; } .vlp-layout-blogs .vlp-block-0 {font-weight: 600!important; } .ct-container-narrow {max-width: 1200px!important;}  <\/style><script> function lewemenu(zm) { var elements = document.getElementsByClassName(\"menu-lewe\"); var i,link1,link2; for (i = 0; i < elements.length; i++) {    link1 = elements[i].getElementsByTagName(\"a\");     link1[0].style.fontWeight = \"600\";     link1[0].style.backgroundColor= \"#FAFAFA\"; } link2 = elements[zm].getElementsByTagName(\"a\"); link2[0].style.fontWeight = \"600\"; link2[0].style.backgroundColor= \"#E9F4FE\"; } <\/script><div class=\"wp-block-getwid-section alignfull alignfull getwid-margin-top-none getwid-margin-bottom-none getwid-section-content-full-width\"><div class=\"wp-block-getwid-section__wrapper getwid-padding-top-none getwid-padding-bottom-none getwid-padding-left-none getwid-padding-right-none getwid-margin-left-none getwid-margin-right-none\" style=\"min-height:100vh\"><div class=\"wp-block-getwid-section__inner-wrapper\"><div class=\"wp-block-getwid-section__background-holder\"><div class=\"wp-block-getwid-section__background\"><\/div><div class=\"wp-block-getwid-section__foreground\"><\/div><\/div><div class=\"wp-block-getwid-section__content\"><div class=\"wp-block-getwid-section__inner-content\"><div class=\"wp-block-columns alignfull artykul is-layout-flex wp-container-core-columns-is-layout-f96e3eba wp-block-columns-is-layout-flex\" style=\"margin-top:0px;margin-bottom:0px\"><div class=\"wp-block-column paskek-lewy spis is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:270px\"><div class=\"wp-block-columns jazda is-layout-flex wp-container-core-columns-is-layout-995f960e wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><p class=\"has-text-align-left has-link-color wp-elements-ce7ce8fee1e672e130d03df3c959d2c6 wp-block-paragraph\" style=\"margin-left:10px;font-size:clamp(16.293px, 1.018rem + ((1vw - 3.2px) * 0.68), 25px);font-style:normal;font-weight:600;letter-spacing:-0.01em;line-height:1.2\">Table of Contents<\/p><p class=\"has-link-color wp-elements-62384ec5c8b7a1163bf3b9169591b5f2 wp-block-paragraph\"><p class=\"menu-lewe has-link-color\" onclick=\"lewemenu(0)\"><a href=\"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/#section1\" data-type=\"URL\" data-id=\"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/#section1\"  style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.391), 19px);font-style:normal;font-weight:600;line-height:1.2;color:#0c3658\">Introduction<\/a><\/p><\/p><p class=\"has-link-color wp-elements-a9c0e2b4268b54d1a5a0e18eb6fd76dc wp-block-paragraph\"><p class=\"menu-lewe has-link-color\" onclick=\"lewemenu(1)\"><a href=\"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/#section2\" data-type=\"URL\" data-id=\"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/#section2\"  style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.391), 19px);font-style:normal;font-weight:600;line-height:1.2;color:#0c3658\">KanBo: When, Why and Where to deploy as a Process Management tool<\/a><\/p><\/p><p class=\"has-link-color wp-elements-df25a581a2e4f0db581406e3a6edddbc wp-block-paragraph\"><p class=\"menu-lewe has-link-color\" onclick=\"lewemenu(2)\"><a href=\"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/#section3\" data-type=\"URL\" data-id=\"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/#section3\"  style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.391), 19px);font-style:normal;font-weight:600;line-height:1.2;color:#0c3658\">How to work with KanBo as a Process Management tool<\/a><\/p><\/p><p class=\"has-link-color wp-elements-e8a5ecf52a301cec8bdc1c900f7a8d06 wp-block-paragraph\"><p class=\"menu-lewe has-link-color\" onclick=\"lewemenu(3)\"><a href=\"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/#section4\" data-type=\"URL\" data-id=\"https:\/\/kanboapp.com\/en\/advancing-global-drug-development-embracing-process-management-techniques-in-downstream-pharmaceutical-processing\/#section4\"  style=\"font-size:clamp(14px, 0.875rem + ((1vw - 3.2px) * 0.391), 19px);font-style:normal;font-weight:600;line-height:1.2;color:#0c3658\">Glossary and terms<\/a><\/p><\/p><\/div><\/div><\/div><div class=\"wp-block-column kolumna-tekst is-layout-flow wp-block-column-is-layout-flow\"><div class=\"wp-block-getwid-section alignfull sekcja-tekst alignfull getwid-margin-top-none getwid-margin-bottom-none getwid-section-content-full-width\"><div class=\"wp-block-getwid-section__wrapper getwid-padding-top-none getwid-padding-bottom-none getwid-padding-left-none getwid-padding-right-none getwid-margin-left-none getwid-margin-right-none\" style=\"min-height:100vh\"><div class=\"wp-block-getwid-section__inner-wrapper\"><div class=\"wp-block-getwid-section__background-holder\"><div class=\"wp-block-getwid-section__background has-background\" style=\"background-color:#fafafa\"><\/div><div class=\"wp-block-getwid-section__foreground\"><\/div><\/div><div class=\"wp-block-getwid-section__content\"><div class=\"wp-block-getwid-section__inner-content\"><h1 class=\"wp-block-heading tytulek\" style=\"margin-bottom:40px;font-size:clamp(21.536px, 1.346rem + ((1vw - 3.2px) * 1.052), 35px);font-style:normal;font-weight:700;letter-spacing:-0.02em;line-height:1.2\">Advancing Global Drug Development: Embracing Process Management Techniques in Downstream Pharmaceutical Processing<\/h1><h2 class=\"wp-block-heading naglowek-duzy\" id=\"section1\" style=\"margin-bottom:40px;font-size:clamp(16.293px, 1.018rem + ((1vw - 3.2px) * 0.68), 25px);font-style:normal;font-weight:700;letter-spacing:-0.02em;line-height:1.2\">Introduction<\/h2><p class=\"tekst-para wp-block-paragraph\">Process management is an integral framework pertinent to the field of Downstream Process Development, particularly within the realm of Global Drug Development (GDD). In this context, it refers to the strategic oversight and optimization of workflows related to the purification and formulation of pharmaceuticals following their biosynthesis or chemical synthesis. This involves meticulous planning, coordination, and refinement of various stages, including but not limited to, separation, purification, concentration, and formulation of the drug compounds to meet strict quality and regulatory standards.<\/p><p class=\"tekst-para wp-block-paragraph\">At the heart of process management in GDD lies the commitment to enhance therapeutic innovation and manufacturing efficiency. By implementing robust process management strategies, experts in science and technology are able to streamline operations, ensuring that from bench to bedside, the transition of drug substances through downstream stages is seamless, cost-effective, and upholds the highest level of product integrity. This in turn significantly contributes to the mission of transforming lives through the development of groundbreaking and life-altering medicines.<\/p><h3 class=\"wp-block-heading naglowek-duzy\" id=\"section2\" style=\"margin-bottom:40px;font-size:clamp(16.293px, 1.018rem + ((1vw - 3.2px) * 0.68), 25px);font-style:normal;font-weight:700;letter-spacing:-0.02em;line-height:1.2\">KanBo: When, Why and Where to deploy as a Process Management tool<\/h3><p class=\"tekst-para wp-block-paragraph\">What is KanBo?<\/p><p class=\"tekst-para wp-block-paragraph\">KanBo is a comprehensive platform designed for managing workflows and processes across various business functions. It provides users with a visual representation of tasks and allows for real-time monitoring of project progress. With features such as customizable cards, statuses, activity streams, and integration with Microsoft products, KanBo is geared towards enhancing coordination, communication, and efficiency in process management tasks.<\/p><p class=\"tekst-para wp-block-paragraph\">Why?<\/p><p class=\"tekst-para wp-block-paragraph\">KanBo offers an array of features that facilitate detailed project planning, tracking, and execution. It allows for the seamless organizing of work into structured hierarchies and includes aspects such as card relations, statistics, and date management. The tool's ability to accommodate hybrid on-premises and cloud deployments ensures that specific data management requirements, including the sensitive data handled in scientific environments, are met. The extensive customization options allow processes within Downstream Process Development to be tailored to fit unique operational requirements.<\/p><p class=\"tekst-para wp-block-paragraph\">When?<\/p><p class=\"tekst-para wp-block-paragraph\">KanBo should be utilized for process management whenever there is a need to streamline workflows, enhance communication, or manage complex projects with multiple stakeholders and intricate dependencies. In Downstream Process Development, it is particularly beneficial when coordinating multiple steps involved in purifying and manufacturing biological substances, monitoring timelines, and ensuring compliance with quality standards throughout the development lifecycle.<\/p><p class=\"tekst-para wp-block-paragraph\">Where?<\/p><p class=\"tekst-para wp-block-paragraph\">KanBo can be effectively used in both office and laboratory environments that involve Downstream Process Development workflows. Given its integration with cloud services, it can also be accessed remotely, making it ideal for teams that operate in diverse locations or include members working remotely or across different sites.<\/p><p class=\"tekst-para wp-block-paragraph\">Why should experts in Science & Technology - Downstream Process Development use KanBo as a Process Management tool?<\/p><p class=\"tekst-para wp-block-paragraph\">Professionals in the field of Downstream Process Development should use KanBo as a process management tool due to its customizable workflow options that can mirror scientific processes, its card relations for managing dependencies between various stages of product development, and its ability to handle complex data sets securely. Its integration with Microsoft products can streamline the reporting and documentation necessary in scientific work. Moreover, the Gantt and Forecast Chart views are particularly useful for visualizing project timelines and predicting completion dates, which are critical in planning scale-up and transfer to manufacturing processes. The analytic capabilities provided by KanBo's card statistics allow for continuous process optimization, an integral part of scientific development work.<\/p><h3 class=\"wp-block-heading naglowek-duzy\" id=\"section3\" style=\"margin-bottom:40px;font-size:clamp(16.293px, 1.018rem + ((1vw - 3.2px) * 0.68), 25px);font-style:normal;font-weight:700;letter-spacing:-0.02em;line-height:1.2\">How to work with KanBo as a Process Management tool<\/h3><p class=\"tekst-para wp-block-paragraph\">Step 1: Define and Map Existing Processes<\/p><p class=\"tekst-para wp-block-paragraph\">_Purpose:_ To understand the current state of downstream process workflows and identify existing inefficiencies, redundancies, or bottlenecks.<\/p><p class=\"tekst-para wp-block-paragraph\">_How to Use KanBo:_<\/p><p class=\"tekst-para wp-block-paragraph\">- Create a New Workspace named \"Downstream Process Development\" for capturing all related Spaces.<\/p><p class=\"tekst-para wp-block-paragraph\">- Construct Spaces for each major downstream process activity (e.g., Purification, Filtration, Chromatography).<\/p><p class=\"tekst-para wp-block-paragraph\">- Within each Space, utilize Cards to represent individual tasks or sub-processes, ensuring each card includes the current method or procedure used.<\/p><p class=\"tekst-para wp-block-paragraph\">- Employ the Card Activity Stream to log historical changes or notes that provide insights into each process's performance.<\/p><p class=\"tekst-para wp-block-paragraph\">_Why:_ By visualizing the workflows, you can objectively evaluate and collaborate on them, fostering a shared understanding of the process' current state and potential areas for optimization.<\/p><p class=\"tekst-para wp-block-paragraph\">Step 2: Identify Key Performance Indicators (KPIs)<\/p><p class=\"tekst-para wp-block-paragraph\">_Purpose:_ To establish metrics that will be used to measure the effectiveness and efficiency of downstream process workflows.<\/p><p class=\"tekst-para wp-block-paragraph\">_How to Use KanBo:_<\/p><p class=\"tekst-para wp-block-paragraph\">- Within each Space related to process activities, create Cards for KPIs.<\/p><p class=\"tekst-para wp-block-paragraph\">- Document KPIs, such as yield rates, purity levels, time-to-completion, and cost-efficiency.<\/p><p class=\"tekst-para wp-block-paragraph\">- Leverage Card Statistics to analyze historical performance data for these KPIs.<\/p><p class=\"tekst-para wp-block-paragraph\">_Why:_ KPIs are essential for quantifying the performance of existing processes, setting benchmarks, and measuring the impact of process improvements.<\/p><p class=\"tekst-para wp-block-paragraph\">Step 3: Analyze and Identify Improvement Opportunities<\/p><p class=\"tekst-para wp-block-paragraph\">_Purpose:_ To pinpoint specific process aspects that require enhancement, streamlining, or re-engineering.<\/p><p class=\"tekst-para wp-block-paragraph\">_How to Use KanBo:_<\/p><p class=\"tekst-para wp-block-paragraph\">- Use Card Issues to highlight problems or inefficiencies within each process task.<\/p><p class=\"tekst-para wp-block-paragraph\">- Establish Card Relations to understand dependencies that may impact flow or create bottlenecks.<\/p><p class=\"tekst-para wp-block-paragraph\">- Implement Card Blockers to flag and categorize obstacles that prevent progress, necessitating attention and resolution.<\/p><p class=\"tekst-para wp-block-paragraph\">_Why:_ By identifying the weak points and constraints, you can focus optimization efforts on the areas that will most significantly improve process performance.<\/p><p class=\"tekst-para wp-block-paragraph\">Step 4: Design and Model Optimized Processes<\/p><p class=\"tekst-para wp-block-paragraph\">_Purpose:_ To create revised process maps that reflect desired changes, improvements, or redesigns for enhanced performance.<\/p><p class=\"tekst-para wp-block-paragraph\">_How to Use KanBo:_<\/p><p class=\"tekst-para wp-block-paragraph\">- Create New Spaces or duplicate existing ones to model the optimized processes, keeping legacy information for comparison.<\/p><p class=\"tekst-para wp-block-paragraph\">- Utilize Cards to outline the new or revised tasks including updated methods and expected outcomes.<\/p><p class=\"tekst-para wp-block-paragraph\">- Apply Card Grouping to organize tasks by new KPIs or process flow stages.<\/p><p class=\"tekst-para wp-block-paragraph\">_Why:_ Modeling provides a clear proposal for change and a conceptual view of the improved process, allowing stakeholders to review and provide input before implementation.<\/p><p class=\"tekst-para wp-block-paragraph\">Step 5: Implement and Monitor Optimized Processes<\/p><p class=\"tekst-para wp-block-paragraph\">_Purpose:_ To execute the improved processes in the operational environment and closely monitor them to ensure they perform as intended.<\/p><p class=\"tekst-para wp-block-paragraph\">_How to Use KanBo:_<\/p><p class=\"tekst-para wp-block-paragraph\">- Transition from the modeled Spaces to live operational Spaces, ensuring all process Cards are updated and represent the new workflows.<\/p><p class=\"tekst-para wp-block-paragraph\">- Monitor KPIs through Card Statistics and Forecast Chart view to assess the performance of the optimized processes against set targets.<\/p><p class=\"tekst-para wp-block-paragraph\">- Engage in continuous Activity Stream monitoring to ensure tasks adhere to the new process guidelines and promptly address any issues.<\/p><p class=\"tekst-para wp-block-paragraph\">_Why:_ Implementation with continuous monitoring allows for real-time adjustments and ensures that process changes lead to the expected improvements.<\/p><p class=\"tekst-para wp-block-paragraph\">Step 6: Review, Refine, and Sustain Optimizations<\/p><p class=\"tekst-para wp-block-paragraph\">_Purpose:_ To review the outcomes of process changes, refine them for further benefits, and maintain ongoing process excellence.<\/p><p class=\"tekst-para wp-block-paragraph\">_How to Use KanBo:_<\/p><p class=\"tekst-para wp-block-paragraph\">- Schedule regular reviews within KanBo Calendar (Gantt Chart view) to assess the long-term performance of the optimized processes.<\/p><p class=\"tekst-para wp-block-paragraph\">- Use feedback from the Card Activity Stream and Card Blockers to refine and further improve the processes.<\/p><p class=\"tekst-para wp-block-paragraph\">- Maintain a Space dedicated to lessons learned, best practices, and process documentation to sustain optimizations over time.<\/p><p class=\"tekst-para wp-block-paragraph\">_Why:_ Continuous improvement is central to process management. Reviewing and refining ensure that optimizations deliver sustained value while adapting to evolving business needs.<\/p><h3 class=\"wp-block-heading naglowek-duzy\" id=\"section4\" style=\"margin-bottom:40px;font-size:clamp(16.293px, 1.018rem + ((1vw - 3.2px) * 0.68), 25px);font-style:normal;font-weight:700;letter-spacing:-0.02em;line-height:1.2\">Glossary and terms<\/h3><p class=\"tekst-para wp-block-paragraph\">Here's a simplified glossary with explanations for terms related to process management within the context of science, technology, and specifically downstream process development:<\/p><p class=\"tekst-para wp-block-paragraph\">Process Management: A structured approach to managing and optimizing an organization's workflows and processes to ensure alignment with strategic objectives.<\/p><p class=\"tekst-para wp-block-paragraph\">Workflow: The sequence of processes through which a piece of work passes from initiation to completion.<\/p><p class=\"tekst-para wp-block-paragraph\">Project Progress: The advancement of tasks within a project as measured against the planned timeline and goals.<\/p><p class=\"tekst-para wp-block-paragraph\">Task Management: The process of managing a task throughout its lifecycle, including planning, testing, tracking, and reporting.<\/p><p class=\"tekst-para wp-block-paragraph\">Real-time Monitoring: The continuous observation and reporting of a process or activity immediately as it occurs, enabling quick response to any changes.<\/p><p class=\"tekst-para wp-block-paragraph\">Card: A visual representation of a task or a piece of work that contains relevant information like status, deadlines, and responsibilities.<\/p><p class=\"tekst-para wp-block-paragraph\">Status: The current stage of a task or process which indicates progress within a workflow.<\/p><p class=\"tekst-para wp-block-paragraph\">Activity Stream: A real-time list of all the actions and changes made to a particular task, providing transparency and historical context.<\/p><p class=\"tekst-para wp-block-paragraph\">Customizable Workflows: Tailored processes designed to meet the specific requirements of a given task, project, or operational need.<\/p><p class=\"tekst-para wp-block-paragraph\">Microsoft Integration: The compatibility and seamless functioning of a system in conjunction with Microsoft products such as SharePoint, Teams, and Office 365.<\/p><p class=\"tekst-para wp-block-paragraph\">Hybrid Deployment: A system setup that combines both on-premises and cloud-based software solutions.<\/p><p class=\"tekst-para wp-block-paragraph\">Sensitive Data Handling: Management practices that ensure the protection and confidentiality of data that is classified as sensitive.<\/p><p class=\"tekst-para wp-block-paragraph\">Gantt Chart: A type of bar chart that illustrates a project schedule and shows the dependency relationships between activities.<\/p><p class=\"tekst-para wp-block-paragraph\">Forecast Chart: A visual tool showing projected future progress or outcomes, typically based on historical data.<\/p><p class=\"tekst-para wp-block-paragraph\">Downstream Process Development: The phase in biomanufacturing where biological products are recovered and purified to the required standards.<\/p><p class=\"tekst-para wp-block-paragraph\">Compliance: Adherence to laws, regulations, guidelines, and specifications relevant to the process or industry.<\/p><p class=\"tekst-para wp-block-paragraph\">Continuous Improvement: An ongoing effort to improve products, services, or processes by making incremental enhancements over time.<\/p><p class=\"tekst-para wp-block-paragraph\">Operational Excellence: The practice of consistently and reliably managing and executing business operations to achieve superior results.<\/p><p class=\"tekst-para wp-block-paragraph\">Bottlenecks: Points of congestion in a system that slow down the process flow, reducing efficiency and potentially causing delays.<\/p><p class=\"tekst-para wp-block-paragraph\">Optimization: The process of making modifications to a system to perform at its best, often with the goal of maximizing some set of parameters without violating constraints.<\/p><p class=\"tekst-para wp-block-paragraph\">Scalability: The capability of a system to handle a growing amount of work or its potential to accommodate growth.<\/p><p class=\"tekst-para wp-block-paragraph\">Stakeholders: Individuals or groups who have an interest or concern in an organization and can affect or be affected by its activities.<\/p><p class=\"tekst-para wp-block-paragraph\">Dependencies: Relationships between tasks or processes where one cannot start or finish before another has started or finished.<\/p><div style=\"height:120px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"wp-block-column paskek-prawy spis is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:270px\"><div class=\"wp-block-columns 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