Business Process Management
PRODUCTS
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At ProPharma, our Cell and Gene Therapy consulting team offers a comprehensive and integrated approach to early-stage cell and gene therapy development. Our expert team provides a range of services, including IND/CTA preparation, manufacturing technology, safety and risk assessment, and development planning, to help our clients navigate the complex and ever-changing landscape of cell and gene therapy development.
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Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?
Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.
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While there are industry standards for program and project management, each company has a unique culture and is at a different point in their product development journey. Verista's experienced team works with you to effectively manage and control your project, programs and portfolios.
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In cell and gene therapies, the process is the product. We have deep expertise developing and scaling processes for cell therapies and viral vectors, including lentiviral vectors and AAV.
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The Challenge: Building Scalable Viral Vector Programs
Cell and gene therapies offer unprecedented hope for previously untreatable diseases. At the heart of many of these advanced therapies, including both gene therapies and gene-modified cell therapies, are viral vectors, particularly Adeno-Associated Vectors (AAV) and Lentiviral Vectors (LVV), which serve as crucial gene-delivery vehicles.
WHITE PAPERS AND CASE STUDIES
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Driving Customer Profitability With Enterprise Platform, Pricing
Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.
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PlantPAx Distributed Control System Reduces Downtime For Mallinckrodt
Learn how the nation's leading supplier in prescription pain medication completely upgraded their control system, resulting in greater diagnostic/troubleshooting information and reducing downtime.
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Elevating Downstream Process Development With Real-Time Data Monitoring
Learn how real-time monitoring with PAT enhances process control, shortens development timelines, and supports the shift toward continuous manufacturing in biopharmaceutical production.
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Understanding Ultrapure Water, Difficulties With pH Measurement
By gaining insights into the diverse types of pH measuring analyzers and sensors, companies can make informed decisions to enhance their UPW management strategies and drive operational excellence.
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Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays
Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
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The Burden Of MES Vendor Cloud Migration In Drug Manufacturing
Uncover the challenges and limitations of on-premise MES vendor cloud migration, and explore the modern, cloud-based solutions that can circumvent them.
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Geoinfo Services Designs A Low-Carbon Water System To Provide Clean, 24/7 Service To One Of India's Holiest Cities
In this case study, read about a network design that reduced energy use while improving health and quality of life for one of India's holiest cities.
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Office Of Naval Research Contract Leads To New Chlorine Sensor Technology
Developed from U.S. Office of Naval Research requirements, this multiparameter chlorine sensor offers extended maintenance-free operation, flow-independence, and automatic compensation for reliable, in-pipe monitoring.
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From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation
Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.
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Leeton Shire Improves Efficiency And Service Levels With An Affordable, Intuitive Digital Solution
Although Leeton Shire already had some digital technologies in place, such as SCADA, GIS and AMI, they lacked hydraulic modeling capabilities and expertise — which is why they turned to Qatium’s open and secure water management platform.
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Partner Case Study: Accelerating Gene Editing Manufacturing
Beam Therapeutics partnered with ElevateBio to manufacture BEAM-101, a novel base editing therapy for sickle cell disease, advancing rapid, high-quality production towards clinical trials.
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How NetSuite And Coupa Integration Helps Biotech Companies Streamline Processes And Manage Growth
Discover how a therapeutics company began the search for a business spend management solution that would automate everything from procurement to payments and integrate seamlessly with a new ERP.
NEWS
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SAP Unveils AI-Powered Innovations For Network-Centric Supply Chain Management5/22/2025
The innovations we unveiled represent a fundamental shift in how businesses can approach their operations in an increasingly complex global landscape.
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FieldPulse And CHIIRP Partner To Automate Lead Conversion And Drive Growth For Trades Businesses3/11/2025
FieldPulse, the leading field service management software, has partnered with CHIIRP, a marketing and communication automation platform, to help service businesses maximize lead conversion, increase revenue, and enhance customer communication.
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ANCA Microx ULTRA Grinding Machine And AIMS Connect Highlighted At IMTS 20246/13/2024
At IMTS 2024, ANCA CNC Machines has much to offer the market and is also celebrating several highpoints in its storied history.
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Team Provides A Roadmap For Large Language Models In Chemical Research6/30/2025
"There is a common misconception that using large language models in research is like asking an oracle for an answer. The reality is that nothing works like that," Gabe Gomes said.
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Lighthouse Launches AI-Based Intelligent Channel Management With Pricing, Promotion And Distribution Capabilities For Independent Hotels7/18/2024
Lighthouse (formerly OTA Insight), the leading commercial platform for the travel and hospitality industry, today announced the release of Channel Manager. This industry-first AI-powered solution transforms pricing, promotion, and distribution for independent hotels