In the rapidly evolving landscape of bioprocessing manufacturing, efficiency, quality, and compliance are paramount. To support the critical role that researchers play in the production of monoclonal antibody (mAb) substances, the new Process Management Solution for Thermo Scientific™ SampleManager™ LIMS software is a game-changer for bioprocessing workflows.
The solution was designed in partnership with Thermo Fisher’s Bioprocessing Collaboration Center in St. Louis, Missouri to advance the sites production of mAbs, enhancing bioprocess workflows and enabling our customers to take their products to market faster and with greater efficiency.
The Process Management Solution manages recipes and guides analysts through the manufacturing process of monoclonal antibodies, to increase productivity while meeting the required quality, performance, and meta data parameters.
Batch management
One of the key benefits of the Process Management Solution is the ability to manage your batches with ease. It allows labs to effectively track different production batches, ensuring consistency and quality in production. The electronic batch record capability records all data collected during the execution of the batch recipe, eliminating the need for creating and maintaining paper batch records. Moreover, the solution significantly reduces batch and manual errors, leading to cost savings associated with rework and waste.
Recipe management
The Process Management Solution enables users to manage master and control recipes in a single repository to seamlessly track performance and metadata. Users can use the included master recipes as templates for creating control recipes to increase success rates and increase the number of successful batches during the creation of mAbs. In addition, users can insert their created master recipes, unit operations, procedures, and phases into the system.
To enhance the analysts’ experience and ensure quick and accurate decision making, the master recipes are directly linked to a sample result management system to provide easy storage of test records and instant review of the results. The recipe management capability provides a clear, structured, and standardized workflow, reinforcing consistency and quality in production.
Process standardization
The Process Management Solution also promotes process standardization, ensuring every step is performed accurately and efficiently, enforcing consistency and structure in executing batches. This feature, combined with automatic data validation, ensures consistent quality and compliance with industry standards such as the ISA-88/95 framework.
Centralized data repository
One of the key benefits of the Process Management Solution is its ability to centralize all data generated throughout the production process in a secure and easily accessible platform. Scientists can easily generate custom reports tailored for internal reviews and regulatory agency reviews. This not only provides a comprehensive overview of the entire production process but also allows for instant review of results.
Advancing monoclonal antibody production
With additional features like optimized resource utilization, custom report generation, and enhanced sample management – including labeling, tracking, and inventory management, the Process Management Solution is configured to provide bioprocess manufacturing labs with a quicker path from master recipes to quality batches.
Ready for a demo of the solution? Visit our website to learn more and contact our team of experts to address any questions.
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