With the ever-changing mechanics of innovation in the manufacturing environment, work from home and federal regulation validation strategies need to evolve to accommodate the new space. This white paper provides the background, rationale, and strategy for innovating validation for cell and gene therapy manufacturing. We focus on adapting to the unique challenges that advanced cell and gene therapy manufacturing encounters. How do you overcome supply chain, cost, volume, and speed and sensitivity issues specific to advanced cell and gene therapy products? Read this whitepaper for the latest in innovative strategies.

Table of Contents

    • History
    • The Concept
    • Issues in Cell and Gene Therapy Manufacturing
    • Innovative Strategies Overview
    • PDCA Cycle
    • Productivity Tools
    • Paperless Validation
    • Real-time Monitoring
    • Cross-functional Teams
    • The Five Pillars
    • Strategies for Bringing Innovative Cell and Gene Therapies to Market
    • Summary
    • About Us
Innovation in Validation: Advancing Cell and Gene Therapies White Paper

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PSC® can assist in bringing your new cell or gene therapy to clinic

PSC Software®

PSC Software® provides innovative technology options for validation data and team communication for regulatory compliance. PSC Software® provides industry-leading real-time quality management software to ensure regulatory compliance goals are met while reducing business costs. See PSCSoftware.com for more information on our adaptive compliance engine (ACE®) products and inspection management system, AUDITUTOPIA®.

PSC Biotech®

PSC Biotech® consultants act as a seamless extension of your company to assist you in accomplishing the projects required to produce the highest quality products. See Biotech.com for more information about the services that we provide. PSC Biotech® has served life science companies in 52 countries across the globe. Contact us for a free consultation on tailored and cost-efficient project assistance for all your quality, validation, systems, and regulatory needs!

We look forward to hearing about your needs in Cell and Gene Therapies and whether we can be of service. Please get started by emailing us at info@biotech.com or using our contact form online. We have options for professional services and software across a range of budgets and constraints.

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