Organizations need to manage chemicals safely from receipt to disposal along the entire lab-to-plant value chain, ensuring Environmental Health and Safety (EH&S) compliance across the enterprise.
Today’s science-based companies are very aware of the importance of Quality in conducting a successful business and sustaining competitive advantage. Therefore, many enterprises have a Quality Strategy in place.
Many research organizations are increasing their efforts in biotherapeutic discovery, development and manufacturing. The BIOVIA Biologics Solution is a suite of capabilities supported by a common platform designed to help overcome barriers to innovation and process efficiency for the discovery and optimization of biotherapeutic candidates and the optimization of the overall workflow that includes development, manufacturing and compliance processes.
The BIOIVIA Signal Monitoring Dashboard (SMD) solution is a purpose-built validation-ready environment that satisfies requirements for Continued Process Verification (CPV), process robustness and process performance visibility needs across local operations and global manufacturing networks that include Contract Manufacturing Organizations (CMO’s). Automated alerts driven by a sophisticated and flexible rules engine provide review-by-exception for efficient Process and Product Monitoring (PPM) that includes direct connections to process and quality databases as well as CFR 21 Part 11-compliant capture of paper based data.
BIOVIA’s Process Production Operations solution, BIOVIA Discoverant, is a validation-ready solution for process and quality data access, aggregation, contextualization, analysis and reporting. BIOVIA Discoverant empowers production operations in process industries like life science or specialty chemicals to shorten time to market and maximize profitability by enabling understanding of critical process drivers that drive desired business results, monitoring variability for preemptive action and leveraging opportunities to maximize sustainability.
Biologics manufacturers are challenged today with reducing variability and costs, as well as speeding time to market by collaborating across growing manufacturing networks with external and internal partners spread across the globe. As they strive to develop and improve process performance and quality to meet business, regulatory and patient needs, effective utilization of their process and quality data is critical to success. The Biologics Made Right First Time Industry Process Exerience enables understanding of critical bioprocess drivers, monitoring variability for preemptive action and leveraging opportunities to maximize sustainability and maximize profitability and shorten time to market.
BIOVIA Laboratory Information Management System is purpose-built to manage 21st-century product and process informatics requirements with a specific focus on scale-up, manufacturing and compliance that eliminates the complexities, excessive customization and lengthy associated validation requirements inherent with legacy BIOVIA LIMS. The result is streamlined deployment, substantially lower total cost of ownership and rapid time to value.
A critical issue in supplying costly and sensitive biological drugs for clinical trials is the quality of packaging components and materials. Not only must it be robust enough to protect against temperature excursions, the packaging must also prevent damage due to humidity, light, oxygen, shocks, pressure, vibrations and X-rays encountered during any shipping method—truck, train, boat or plane.
Thermo Scientific CX5-14 film is engineered to meet the most demanding requirements of your bioproduction processes.
The S.U.F. is engineered for optimal oxygen mass transfer, mixing, and temperature control, and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work is streamlined – offering you cost savings and efficiency.
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