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Advanced Therapeutic Medicinal Products

A Revolutionary Approach to Life Sciences Manufacturing
Female Scientist Analyzes Liquid in the Beaker and Types Down Observations on Her Computer. She's Working in a Busy Laboratory Full of Scientists Conducting Experiments.
Life Sciences
    • Biotechnology
    • Biotechnology
    • Medical Device
    • Medical Device
    • Pharmaceutical
    • Pharmaceutical
    • ATMP
    • ATMP
    • Serialization
    • Serialization
    • Building Management Systems for Pharma
    • Building Management Systems for Pharma
    • Single-Use Bioprocessing
    • Single-Use Bioprocessing
    • Analytics
    • Analytics
    • Quality & Compliance
    • Quality & Compliance
    • Batch Performance Analytics
    • Batch Performance Analytics
    • Plug & Produce
    • Plug & Produce
  • Sustainability

The Advanced Therapies Revolution

Personalized medicine holds immense potential for transforming healthcare by supplying tailored treatments to each patient, but the manufacturing process faces obvious challenges. Overcoming these hurdles requires a specific set of solutions. By addressing these challenges, the process of manufacturing personalized medicine becomes streamlined, providing patients with targeted and effective treatments quickly, which significantly improves patient outcomes.

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The ATMP Journey

Each year, ATMP trials contribute to more than $23 billion in investments. Strong technology foundations and flexible solutions are what make the difference in patent exclusivity, expanding operations to clinical trials, and a speedy time to market. Classified into three main categories, gene therapies, somatic-cell therapies, and tissue-engineered medicines, the ATMP journey’s future focus is on implementing agile and flexible systems to allow for swift adaptation and scalability across the rapidly evolving landscape.

Pre-clinical
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  • Basic discovery process
  • Pre-clinical research
  • Academic setting
Clinical trials and regulatory reviews
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  • Investigational New Drug (IND) application with FDA
  • Clinical study trials
  • Proof of reliable process and robust controls for approval
Commercial Production
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  • New Drug Application (NDA) approval
  • Scale operations for market launch

Key challenges affecting your ATMP Journey

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Data management & time to market

Real-time release impeded by manual activities, lacking qualified automation, inefficient line and product change over, and an inability to achieve digital technology transfers.

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Process complexities & scaling

Costly scaling efforts due to higher number of SKUs and smaller batch sizes. Complexity of manufacturing ATMP exacerbates issues.

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Workforce effectiveness

Dependency on tribal knowledge impedes the spread of key skills and amplifies risks of manual activities.

Document Checklist

Regulatory compliance

Disparate and disorganized data impedes alignment with regulatory bodies to ensure product quality and reporting to enable Right to Operate.

Conquer challenges with a holistic digital strategy

Digitization allows new technologies and ideas to be tested quickly and at less cost than what could be done before. Take advantage of new technologies that promote flexible, scalable manufacturing in the world of personalized drug development.

Manufacturing Execution Systems Continued Process Verification Digital Engineering Data Orchestration Scalable Automation Lifecycle Services
High Tech Clean Room
High Tech Clean Room
High Tech Clean Room
High Tech Clean Room
High Tech Clean Room
High Tech Clean Room

FactoryTalk PharmaSuite®

PharmaSuite provides value-based applications to help you adhere to regulatory compliance guidelines, achieve operational excellence, increase the effectiveness of your supply chain, and meet your sustainability goals.

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Batch Performance Analytics

Batch Performance Analytics helps consistently produce batches with set specifications, quickly identifying contributing factors in production variability and helping to improve regulatory compliance by automating data collection, analysis, and reporting of continued process verification.

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Emulate3D™

Using Emulate3D™ digital twin software, see how your machine runs before parts are ordered. Discover controls issues before you go on site. And transport plant personnel to a virtual world where they can train on systems without consequence, predict future performance and simulate line changes.

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FactoryTalk® DataMosaix™

FactoryTalk® DataMosaix™ enables controlled access to relevant and contextualized data. It’s an Industrial DataOps cloud-based, solution that provides flexible and scalable tools to accelerate data usability by domain experts and analysts.

Learn More

PlantPAx®

PlantPAx® enables you to respond more quickly to the demands of your customers and fast-changing specifications. The latest system release has been designed to be an integral part of your digital transformation strategy that helps you be more productive and profitable while reducing operational risk.

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LifecycleIQ™ Services

Empower every stage of your lifecycle journey with lifecycle services that provide integrated industrial analytics, transformative technologies, and unparalleled domain knowledge. Connect, secure, mobilize, and scale your manufacturing operations for greater performance, reliability, safety, and ongoing innovation.

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Manufacturing Execution Systems
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High Tech Clean Room
Continued Process Verification
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High Tech Clean Room
Digital Engineering
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High Tech Clean Room
Data Orchestration
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High Tech Clean Room
Scalable Automation
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High Tech Clean Room
Lifecycle Services
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High Tech Clean Room
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Explore more about Advanced Therapeutic Medicinal Products
ATMP is at the forefront of personalized medicine. Let us help you ease challenges with our innovative solutions.

Explore more about Advanced Therapeutic Medicinal Products

ATMP is at the forefront of personalized medicine. Let us help you ease challenges with our innovative solutions.
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