The Ultimate Guide to Digitizing Cell and Gene Therapy Manufacturing
Excellence Awaits in Your Development of CGTs
In today's rapidly evolving cell and gene therapy landscape where 90% of production is outsourced, manufacturers face unprecedented challenges in scaling from clinical to commercial production. With current capacity meeting only 5%-10% of projected commercial needs, the industry demands innovative solutions. This comprehensive guide reveals how digital transformation can revolutionize your cell and gene therapy manufacturing process, ensuring therapies reach patients faster without compromising quality or compliance.
- Overcome scalability barriers and learn why digital solutions are essential for bridging the gap between promising pipeline and commercial products.
- Eliminate manual processes that cause errors, delays, and compliance risks while reducing batch review times by up to 80%.
- Navigate the unique GMP challenges of personalized "batch-of-one" therapies with flexible, purpose-built digital platforms.
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Fully Digitized, Fully Connected: The Future of CGT Manufacturing
The cell and gene therapy sector continues to experience exponential growth, with the market projected to expand to $177.46 billion by 2034. Yet many CGT manufacturers still rely on manual processes that create bottlenecks, increase errors, and delay releases. Digital transformation isn't just about replacing paper—it's about connecting enterprise systems, automating data collection, and enabling real-time intelligence that prevents costly errors while ensuring end-to-end traceability. By implementing purpose-built cell and gene therapy software, manufacturers can reduce documentation burdens, free operators from administrative tasks, and transform regulatory compliance from a barrier into an innovation driver. Digital solutions that support both autologous and allogeneic production models are becoming essential for companies seeking to deliver therapies to patients faster without sacrificing quality.
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CGT Manufacturing FAQs
How does MES software improve CGT production?
Modern MES solutions eliminate paper-based workflows, reducing data input errors by 90%-100% and accelerating batch record review by up to 80%, enabling operators to focus on producing life-saving cell therapy and gene therapy treatments.
Can digital systems maintain chain of identity?
Purpose-built digital platforms streamline compliance while maintaining chain of identity, providing real-time monitoring and faster release times for personalized "batch-of-one" therapies where every minute matters.
How quickly can we see ROI from digital transformation?
CGT entities implementing digital manufacturing solutions typically see immediate improvements like 75% faster batch reviews, 90% fewer data integrity errors, and 25% reduction in deviations across CGT manufacturing operations.
What regulatory challenges does digitization address?
Digital connectivity helps CGT manufacturers navigate evolving FDA and EMA frameworks by automating compliance documentation, reducing quality testing time (currently 70% of manufacturing lead time), and enabling the "Quality at the Source" approach regulators prefer.
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Download the GuideMasterControl: Powering CGT Manufacturing Excellence
Our purpose-built platform transforms cell and gene therapy manufacturing with measurable results including 75% faster batch reviews, 90% fewer data integrity errors, and 25% reduction in deviations.
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Paperless Production:
Eliminate hundreds-of-pages-long batch records with streamlined digital workflows that capture real-time data.
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Connected Systems:
Break down silos between manufacturing, quality, and equipment management for end-to-end visibility.
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Error-Free:
Reduce preventable errors through automated data entry validation and in-line quality assurance at every step.
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AI-Ready:
Enable continuous process verification with advanced analytics that accelerate time-to-patient by up to 30%.
