Piramal Pharma Solutions (PPS) is pleased to welcome Ash Stevens LLC as a part of the Piramal Group. Leveraging five decades of Ash Stevens’s operational experience and technical expertise, Piramal’s service offering now includes High Potency API (HPAPI) development and manufacturing capabilities. Located in Riverview, USA, our state-of the-art FDA licensed cGMP facility offers a full range of scale and containment options for high potency API manufacturing.
Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises Ltd with a vast network of development and manufacturing facilities located in North America, Europe and Asia.
ÄKTA ready is a liquid chromatography system built for process scale-up and production for early clinical phases. The system can be used with ready-to-use disposable flow paths, eliminating the need for cleaning between products/batches. Two versions of ÄKTA ready are available: one version for only isocratic use and the other with gradient capability.
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.
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.
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