Pharmaceutical Quality Control (QC) laboratories and small-scale (biopharma) production (SSP) are two critical areas of the life sciences industry. While they have distinct operational requirements, both share common challenges related to resource and demand management. In this blog post, I will briefly explore the two types of operations and how Binocs can provide valuable solutions for planning small-scale production operations and QC labs both.
In a rush? Here are the 3 key takeaways
👉 Binocs is optimized for use at sites around the world, not just in QC and CGT teams but also small-scale production labs
👉 Small-scale production shares planning challenges with QC, including the need to effectively manage demand, capacity, scheduling, and planning data
👉 The range of different Binocs features makes it ideal for managing limited resources in experimental and/or low volume production environments
Pharma QC vs Small scale production
While they are responsible for a wide range of Quality-related tasks, pharma QC laboratories primarily focus on analytical testing, ensuring that samples of (typically) large-scale manufacturing batches meet the requisite quality and regulatory standards before release to market. This means processing a stream of samples (which probably differ per product and production step) using complex test methods with varying turnaround-time requirements. It also means managing large numbers of specialist personnel and analytical equipment. This level of complexity, involving lots of moving parts, is exactly why Binocs is used in QC labs around the world as the market leading solution for optimizing laboratory operations through effective resource planning and scheduling.
Small-scale biopharma production, on the other hand, is of course a different business process. Small batches are produced by small teams using relatively low volume bioreactors, typically for R&D and experimental purposes. Manufacturing runs often operate in sequence and can take weeks for the upstream and downstream processes to be completed.
Given these significant differences, it may not seem that Binocs would be well suited to these SSP projects, however you might be surprised by how much value it can add because there’s a number of common characteristics to both processes.
Long term forecasting: Binocs demand management allows small-scale production operations, such as process development labs, to import production plans from other sources (for example, Excel) and organize well ahead of delivery windows. By integrating historical data and trends with project future demand, SSP operations can optimize their capacity and align resources and production capabilities with projected demand. A view of the production plan for different programs of work over the next 24 months
Demand templates: an individual SSP site will typically work within quite a narrow family of products, often involving patterns of manufacturing and in-line quality steps. As such, it is a real time saver for planners to set up Binocs operating model templates that are used to sequence the operations in practice. These sequences can then be used to generate the production sequences automatically and adapt where needed. A list of clinical batches is translated into detailed sequences of operations via an operating model built from a standard template
What-if scenario analysis: SSP requirements can sometimes change, with entire runs needing to be replaced / delayed / fast-tracked in light of evolving priorities or changes in availability of key equipment. This means that long-established plans might need to be revised at the last minute, with potentially significant consequences for subsequent runs. With what-if scenario analysis, Binocs allows planners to review different possible outcomes and identify the best-fit solution. Binocs scenarios allow users to project the potential impact of making changes, such as increasing production by 50%
Resource planning: having a small number of team members and bioreactors / other equipment means that allocating these appropriately is crucial to smooth operations. This is especially true since team members will often also work on projects for other teams and be specialized in particular processes (for instance upscale vs downscale processing), meaning that they need to be carefully planned. Similarly, as the same bioreactors will be used for consecutive products, shut down periods must be scheduled in between runs to accommodate cleaning and calibration activities. This is where Binocs comes into its own. Binocs allows users to clearly view how personnel and equipment have been allocated to different teams and types of task
Competence-based scheduling: Relying on a smaller team size with some shared responsibilities and some specialized tasks means that efficiently planning SSP activities relies heavily on the planner’s knowledge of team member skills and training. With the Binocs competence matrix, each operator’s qualifications to complete different activities is clearly defined at the required level of granularity. This allows the AI-enhanced scheduling algorithm to identify the best available solution to the puzzle combined by planned tasks, available staff & their competences, availability of equipment and business rules linking different tasks together at the click of a button. The Binocs Scheduler allows equipment and personnel to be automatically planned based on the best asset for the task, as defined by training and suitability
Weekly scheduling: as with QC laboratories, our experience shows that SSP personnel scheduling contains only a handful of individual tasks per day. However, for some people (for example, scientists), it may simply not make sense to plan out activities day-by-day. That’s why Binocs includes a setting that allows scheduled tasks to be allocated into weekly buckets that users can organize and execute as suits their daily priorities. Compared to daily scheduling boards, weekly scheduling and kanban boards offer additional options to track progress in a less detailed way
Reporting & KPIs: Since SSP labs may be working for a range of internal clients or working in parallel with other labs, we see a trend where these organizations start to focus more and more on key performance indicators (KPIs) to track trends and make data-driven decisions. The examples we see most frequently include metrics to monitor right first time rates, equipment and team member utilization statistics, and planning adherence. Binocs allows users to analyze their asset usage data via customizable charts, visualizations, and dashboards, empowering them to provide standardized operational reporting. Additionally, Binocs offers fully interactive Gantt charts, allowing users to visualize and modify R&D project plans and production schedules. The Binocs Gantt chart allows for comprehensive and native project planning with real time data derived directly from operational data
Zero-code integration: Seamless interoperability with existing software systems is crucial for SSP labs. Binocs offers zero-code integration, enabling effortless connectivity with third-party software applications. Many low volume manufacturing sites may not use MES or other custom applications to plan production and this is where Binocs can make further dramatic improvements, via its easy-to-use interface that allows Excel lists to be readily and rapidly uploaded. With Binocs business rules, data can be easily imported from an external source (such as Excel) into a native custom table by following an automated workflow
While Binocs is renowned as the market-leading solution for planning QC laboratory operations, its capabilities extend beyond the realm of quality control. By leveraging Binocs’ comprehensive list of features, SSP labs can optimize their operations end-to-end, address resource management challenges, improve scheduling, enhance compliance practices, and drive operational excellence. The platform’s ability to offer interactive Gantt charts, in addition to its other functionalities, enables small-scale production labs to visualize, modify, and collaborate on production schedules with ease.
Binocs proves to be a versatile solution, empowering small-scale production labs to streamline their processes, maximize resource utilization, and meet the stringent requirements of the industry. Want to know more? Let’s have a chat!
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Frederik is VP of Sales at Binocs and has over 25 years of experience in laboratory systems, including as a Project Manager for major LIMS rollouts at various global enterprises. When he joined Bluecrux in 2017, his experience and business development skills significantly boosted the commercial success of Binocs.