ReadyToProcess Adsorber Q is a range of single-use anion exchange membranes for efficient polishing of monoclonal antibodies (MAbs) and other large molecules at high flow rates.
This XDR single-use bioreactor is sized for the benchtop, yet allows smooth scale-up to full production.
Fisher Clinical Services has the industry’s largest network of fully owned cGMP facilities strategically located around the world to support the conduct of clinical trials. Our 16 purpose-built GMP/GDP compliant facilities—located across five continents—provide the global presence, information systems and quality standards to provide clients the flexibility, access and assurance needed for their clinical trial. Our continued investment in cold chain storage, as well as distribution capability across the network, mirrors the industry’s evolution to handle increased quantities of complex cold chain biologics across many continents. Supplementing these 16 facilities are over 30 partner depots across the world, specifically chosen to facilitate drug type or local regulatory requirements.
The complexity of high cost biologics means comparator may be one of the highest line items in your clinical trial budget. Our Comparator Center of Excellence Team can consult and assist you in managing the full breadth of your comparator sourcing needs. Utilizing Fisher Clinical Services’ comparator sourcing services will provide you access to a global sourcing network and an overall de-risked supply chain. Currently 15 out of the top 20 worldwide pharmaceutical and biotechnology companies, as well many small pharmaceutical and biotech start-ups, actively utilize our comparator sourcing and strategy services.
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.
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