Advancing Global Drug Development: Embracing Process Management Techniques in Downstream Pharmaceutical Processing

Introduction

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.

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.

KanBo: When, Why and Where to deploy as a Process Management tool

What is KanBo?

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.

Why?

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.

When?

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.

Where?

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.

Why should experts in Science & Technology - Downstream Process Development use KanBo as a Process Management tool?

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.

How to work with KanBo as a Process Management tool

Step 1: Define and Map Existing Processes

_Purpose:_ To understand the current state of downstream process workflows and identify existing inefficiencies, redundancies, or bottlenecks.

_How to Use KanBo:_

- Create a New Workspace named "Downstream Process Development" for capturing all related Spaces.

- Construct Spaces for each major downstream process activity (e.g., Purification, Filtration, Chromatography).

- Within each Space, utilize Cards to represent individual tasks or sub-processes, ensuring each card includes the current method or procedure used.

- Employ the Card Activity Stream to log historical changes or notes that provide insights into each process's performance.

_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.

Step 2: Identify Key Performance Indicators (KPIs)

_Purpose:_ To establish metrics that will be used to measure the effectiveness and efficiency of downstream process workflows.

_How to Use KanBo:_

- Within each Space related to process activities, create Cards for KPIs.

- Document KPIs, such as yield rates, purity levels, time-to-completion, and cost-efficiency.

- Leverage Card Statistics to analyze historical performance data for these KPIs.

_Why:_ KPIs are essential for quantifying the performance of existing processes, setting benchmarks, and measuring the impact of process improvements.

Step 3: Analyze and Identify Improvement Opportunities

_Purpose:_ To pinpoint specific process aspects that require enhancement, streamlining, or re-engineering.

_How to Use KanBo:_

- Use Card Issues to highlight problems or inefficiencies within each process task.

- Establish Card Relations to understand dependencies that may impact flow or create bottlenecks.

- Implement Card Blockers to flag and categorize obstacles that prevent progress, necessitating attention and resolution.

_Why:_ By identifying the weak points and constraints, you can focus optimization efforts on the areas that will most significantly improve process performance.

Step 4: Design and Model Optimized Processes

_Purpose:_ To create revised process maps that reflect desired changes, improvements, or redesigns for enhanced performance.

_How to Use KanBo:_

- Create New Spaces or duplicate existing ones to model the optimized processes, keeping legacy information for comparison.

- Utilize Cards to outline the new or revised tasks including updated methods and expected outcomes.

- Apply Card Grouping to organize tasks by new KPIs or process flow stages.

_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.

Step 5: Implement and Monitor Optimized Processes

_Purpose:_ To execute the improved processes in the operational environment and closely monitor them to ensure they perform as intended.

_How to Use KanBo:_

- Transition from the modeled Spaces to live operational Spaces, ensuring all process Cards are updated and represent the new workflows.

- Monitor KPIs through Card Statistics and Forecast Chart view to assess the performance of the optimized processes against set targets.

- Engage in continuous Activity Stream monitoring to ensure tasks adhere to the new process guidelines and promptly address any issues.

_Why:_ Implementation with continuous monitoring allows for real-time adjustments and ensures that process changes lead to the expected improvements.

Step 6: Review, Refine, and Sustain Optimizations

_Purpose:_ To review the outcomes of process changes, refine them for further benefits, and maintain ongoing process excellence.

_How to Use KanBo:_

- Schedule regular reviews within KanBo Calendar (Gantt Chart view) to assess the long-term performance of the optimized processes.

- Use feedback from the Card Activity Stream and Card Blockers to refine and further improve the processes.

- Maintain a Space dedicated to lessons learned, best practices, and process documentation to sustain optimizations over time.

_Why:_ Continuous improvement is central to process management. Reviewing and refining ensure that optimizations deliver sustained value while adapting to evolving business needs.

Glossary and terms

Here's a simplified glossary with explanations for terms related to process management within the context of science, technology, and specifically downstream process development:

Process Management: A structured approach to managing and optimizing an organization's workflows and processes to ensure alignment with strategic objectives.

Workflow: The sequence of processes through which a piece of work passes from initiation to completion.

Project Progress: The advancement of tasks within a project as measured against the planned timeline and goals.

Task Management: The process of managing a task throughout its lifecycle, including planning, testing, tracking, and reporting.

Real-time Monitoring: The continuous observation and reporting of a process or activity immediately as it occurs, enabling quick response to any changes.

Card: A visual representation of a task or a piece of work that contains relevant information like status, deadlines, and responsibilities.

Status: The current stage of a task or process which indicates progress within a workflow.

Activity Stream: A real-time list of all the actions and changes made to a particular task, providing transparency and historical context.

Customizable Workflows: Tailored processes designed to meet the specific requirements of a given task, project, or operational need.

Microsoft Integration: The compatibility and seamless functioning of a system in conjunction with Microsoft products such as SharePoint, Teams, and Office 365.

Hybrid Deployment: A system setup that combines both on-premises and cloud-based software solutions.

Sensitive Data Handling: Management practices that ensure the protection and confidentiality of data that is classified as sensitive.

Gantt Chart: A type of bar chart that illustrates a project schedule and shows the dependency relationships between activities.

Forecast Chart: A visual tool showing projected future progress or outcomes, typically based on historical data.

Downstream Process Development: The phase in biomanufacturing where biological products are recovered and purified to the required standards.

Compliance: Adherence to laws, regulations, guidelines, and specifications relevant to the process or industry.

Continuous Improvement: An ongoing effort to improve products, services, or processes by making incremental enhancements over time.

Operational Excellence: The practice of consistently and reliably managing and executing business operations to achieve superior results.

Bottlenecks: Points of congestion in a system that slow down the process flow, reducing efficiency and potentially causing delays.

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.

Scalability: The capability of a system to handle a growing amount of work or its potential to accommodate growth.

Stakeholders: Individuals or groups who have an interest or concern in an organization and can affect or be affected by its activities.

Dependencies: Relationships between tasks or processes where one cannot start or finish before another has started or finished.