Pacira is a newly established specialized pharmaceutical firm with its headquarters in the U.S. that focuses on the commercial and clinical development of innovative drugs that address the needs of acute care practitioners and patients. The company focuses on creating non-opioid medications for post-surgical pain management.
Pacira has created a proprietary product delivery technology (DepoFoam®) that encapsulates drugs without altering their molecular structure and releases them over a predetermined time period. This enhances the products' effectiveness and safety, significantly impacting patients in terms of dosing frequency and administration.
The product EXPAREL®, based on this technology, is marketed to substitute opioids for post-surgical therapy, preventing addiction and overdose fatalities. It is manufactured in Swindon, U.K., and San Diego, U.S.
The emulsion's production is challenging to control, involving two emulsion steps: solvent stripping and buffer addition for storage and potency adjustment.
Challenge: Manual process leading to high costs and a lack of predictive capabilities
The company aims to produce as many products as possible without flaws. To support this, Lean and Six Sigma methodologies were used by Pacira to begin a Continuous Improvement journey in 2016.
Lean helps to guarantee that manufacturing processes have the consistency they need by removing waste and allowing stages to proceed without pauses, delays, or bottlenecks for a faster time to market.
It also enables users to “pull” products as required. Utilizing the appropriate statistical tools for in-process control, Six Sigma assists in reducing variability. Design for Six Sigma can also increase process robustness. These strategies all rely on using data produced throughout the organization.
Pacira previously found it challenging to collect data since it was stored in paper-based documents, spreadsheets, and complicated equipment systems. For data to be useful, it is necessary to know what data is accessible, when it was created, how it was formatted, and whether it is qualitative or quantitative.
Gathering and formatting data was a lengthy process, which prevented the team from gaining insights from the data for impactful decision-making.
Manually aggregated data sets represented only 15% of the total factors their teams measured, and the model could only account for 59% of the outcomes. These gaps prompted Pacira to search for a method that could quicken data gathering, modeling, and prediction.
Solution: Implementing BIOVIA Discoverant to achieve business-driven results
Pacira chose BIOVIA Discoverant as the Tech Transfer and early commercialization solution because it best supports the goal of decreasing time-to-market and increasing production while maximizing product quality.
Without duplicating the content, BIOVIA Discoverant automatically aggregates and preformats content from several systems to serve as a central hub for data access. Data can be readily available for analysis and decision-making without users having to spend time obtaining and formatting it.
Increased data availability means that models can make better predictions covering a broader range of subjects. Data is transformed into usable information.
Using derived parameter functionality, BIOVIA Discoverant carries out statistical analysis and Multiple Linear Regression modeling. Its excellent statistical analysis capabilities allow quicker root cause identification and process optimization with fewer resources.
This allows the organization to maximize yield at an ideal concentration while significantly reducing Out-of-Specification (OOS) test results by cutting those that did not meet the specification.
The manufacturing monitoring capabilities of BIOVIA Discoverant during the production process enable real-time course modifications and prevent in-process scrap. With customizable report generation, BIOVIA Discoverant is now Pacira’s main reporting tool, supplying multiple organizational levels with dashboards as well as standard and custom reports supporting standardization and increased efficiency.
With BIOVIA Discoverant I can see things I didn’t even dream of before.
Ron Ortiz, Director, Manufacturing Science and Technology, Pacira
Results: Reduced cycle times, increased yield, and accelerated profitability
BIOVIA Discoverant enables Pacira to identify critical process parameters and their impact on the process, advancing the strategic goal of gaining a deeper understanding of its complex production process.
By removing data collection, BIOVIA Discoverant automates procedures and makes data conveniently accessible, resulting in significant time savings. Now, three FTEs can be reassigned to activities that will be more productive and significant in developing, researching, and designing new medicines.
With the data and analytics provided by BIOVIA Discoverant for process optimization and root cause analysis, Pacira can enhance product quality and minimize batches that do not meet quality requirements.
This has led to a decrease in rejected lots and scrap material, saving $20K to $500K per failure, depending on the stage in which it occurred.
Pacira can minimize process and product variability and raise the quality yield of the product by utilizing the diagnostic and predictive capabilities of BIOVIA Discoverant.
The manufacturing processes are now more efficient due to the automation capabilities of BIOVIA Discoverant. Bottlenecks are removed, which speeds up the time to market and promotes Pacira’s Lean program.
Pacira’s profitability and bottom line are ultimately improved by BIOVIA Discoverant’s capacity to increase product quality and output while shortening time-to-market.
About BIOVIA, Dassault Systèmes
BIOVIA™ provides global, collaborative product lifecycle experiences to transform scientific innovation. Our solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the way we live.
The industry-leading BIOVIA portfolio integrates the diversity of science, experimental processes and information requirements, end-to-end, across research, development, QA/QC and manufacturing. Capabilities include Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics.
BIOVIA is committed to enhancing and speeding innovation, increasing productivity, improving quality and compliance, reducing costs and accelerating product development for customers in multiple industries.
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