Accelerate ATMP Manufacturing With Purpose-Built Digital Solutions
Transform your advanced therapy medicinal product (ATMP) manufacturing lifecycle with proven, compliant solutions, optimized for batch-of-one production.
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MasterControl Offers 4 Key Advantages
for ATMP Companies
Production Agility
MasterControl enables you to manage the complexities of advanced therapy manufacturing without missing a beat. Need to adapt protocols for an individual patient? No problem. Our platform ensures your ATMP processes can shift as needed without compromising compliance, data integrity, or product quality.
Scalable Infrastructure
Start small, scale fast, and never outgrow your technology. MasterControl supports your entire manufacturing journey — from clinical runs to cGMP commercial production — without disruptive system changes. Our platform evolves alongside your operations, ensuring your rapid innovation is matched by systems that are always ready for what’s next.
Regulatory Confidence
Navigate the global regulatory maze with tools purpose-built for ATMP production. MasterControl systems go beyond just managing documentation — we help you embed compliance into every step of your production process. With robust data integrity, embedded quality controls, and end-to-end traceability, you can move forward with confidence.
Complete Traceability
From collection to delivery, MasterControl helps ensure an unbroken chain of custody across the entire ATMP manufacturing lifecycle. Every step or action is meticulously documented with timestamps, compliant e-signatures, and critical information, ensuring you meet tight timelines while maintaining product integrity.
The Ultimate Guide to Digitising Cell and Gene Therapy Manufacturing
In this guide you’ll learn how ATMP manufacturing is being revolutionised with modern technologies that accelerate time-to-patient, reduce review time by 75%, and ensure right-first-time delivery every time.
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Overcoming 3 Key Challenges Facing Life Science Contract Manufacturers
Discover how life science contract manufacturing organisations (CMOs) and contract development and manufacturing organisations (CDMOs) can address the issues that hinder them from achieving greater operational efficiencies, flexibility, and connectivity with digitisation.
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Solutions for ATMP
Quality
Management and Manufacturing
MasterControl Manufacturing Excellence replaces manual processes and paper-based workflows with digital manufacturing tools built to support ATMP providers. From logbooks and electronic batch records to a full-scale MES, MasterControl enables the traceability, quality control, and agility needed to produce and deliver advanced therapies. A robust integrations portal enables connectivity to critical equipment and systems and ensures an unbroken chain of custody across your production process.
MasterControl Quality Excellence delivers the ultimate QMS for ATMP manufacturing with automated document control, change control, training management, and corrective action/preventive action (CAPA) management. The platform preserves data integrity throughout the development and production lifecycle, while streamlining the complex documentation essential for advanced therapies.
Developers of ATMPs face unique research-to-commercial translation challenges. MasterControl Development Excellence provides the flexible foundation your ATMP manufacturing needs from day one, ensuring proper documentation while accommodating the frequent process changes inherent in ATMP manufacturing.
ATMP manufacturing demands specialized materials and precise coordination. MasterControl Supplier Excellence unifies supplier quality management, approved vendor lists, and corrective actions within a single platform, ensuring quality consistency across your ATMP manufacturing ecosystem even as you scale rapidly.
ATMP companies must vigilantly monitor treatment outcomes and safety profiles. MasterControl Postmarket Excellence enhances your ability to track product performance with robust traceability features that support the unique regulatory requirements of advanced therapies while maintaining GMP compliance.
Resources for ATMP Companies
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GxP Lifeline Blog Posts
Quality and Manufacturing System Implications for Cell and Gene Therapy
With the significant advances in gene and cell therapies, companies producing breakthrough products are facing obstacles ranging from challenges with development to transitioning to commercial manufacturing. Solutions can be found in digital manufacturing execution systems (MES) and quality management systems (QMS).
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Modernizing Your Way to Success in Cell and Gene Therapy Manufacturing
Streamlined production and quality processes are the keys to meeting the rising demand for cell and gene therapy manufacturing expertise and capacity. Find out how digitally bridging the gap between production and quality is helping companies thrive in the CGT space.
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Finding the Best Digital Solutions for Cell and Gene Therapy Manufacturing
Cell and gene therapy manufacturers need modern digital solutions that can take paper out of the production process, connect their teams, and help them stay flexible. Learn how cell therapy pioneer Dendreon used MasterControl Manufacturing Excellence to do just that.
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How to Solve the Big Challenges of Cell and Gene Therapy Manufacturing
Cell and gene therapy (CGT) manufacturing offers unique challenges regarding good manufacturing practices (GMP). Are paper batch records efficient enough to remain compliant? Learn how digital manufacturing solutions can solve some of CGTs biggest production issues.
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Case Studies
Getting Products to Patients Faster With Enhanced QMS and EBR Connectivity
Discover how the digital connectivity enabled by a regenerative medicine and biotherapeutic solutions provider’s integrated QMS and electronic batch record solutions has eliminated paper and helped them get products to patients faster. Learn how the company has simplified audits and eliminated data silos and the delays caused by manual document approvals.
How a Digital Manufacturing Solution Embeds Quality Into Cellular Therapeutics Production
See how immunotherapy pioneer Dendreon cut batch record review time by 50% while maintaining their impressive 99% right-first-time accuracy. With patients counting on timely delivery of their personalised cancer treatment, Dendreon ditched paper for MasterControl's digital solutions, connecting teams across facilities and ensuring life-extending therapies reach patients exactly when needed.
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Begin your journey to fully optimized quality management and manufacturing processes in your ATMP operations.
