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.
As your premier service provider, Althea’s ADC service offerings will simplify your supply chain by consolidating high containment conjugation, formulation, fill finish and release and stability testing at the same facility.
Althea delivers high quality sterile contract manufacturing and thorough inspection systems that are customized to your manufacturing needs. We offer a broad range of sterile dosage forms, including prefilled syringes, liquid vials, and lyophilized vials.
Althea’s focused expertise and capabilities in current Good Manufacturing Practices (cGMP) production of microbial-based biotherapeutics make us one of the industry’s leaders in microbial fermentation. We offer a broad range of microbial-based cGMP biologics manufacturing services to biopharmaceutical companies worldwide. Althea is a recognized leader in plasmid DNA manufacturing for vaccines and gene therapy products. Althea has demonstrated experience in developing and manufacturing nearly 300 cGMP lots of bulk drug substance and has an impeccable regulatory track record. Our comprehensive, validated equipment has been utilized to fulfill numerous drug substance projects for preclinical and clinical supply. For additional information about Althea’s drug substance manufacturing services including contract cGMP microbial fermentation and biologics manufacturing, please contact us.
Althea’s complete range of drug Process Development capabilities offers the tools to address your needs. We develop processes for producing small quantities of proteins for early testing or establish robust, reliable and scalable processes that enable a strong commercial advantage. Althea also provides access to a proprietary drug delivery platform, called Crystalomics® technology, for the development of alternative drug delivery formulations of second generation drug substances.
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