Projections show a $177.46 billion market by 2034 and an 18.7% CAGR. But here’s the reality check: current manufacturing capacity meets only 5%-10% of what’s needed to scale these life-changing therapies.
CGT products don’t just treat conditions. They transform lives. But bringing these breakthrough therapies from lab to patient requires more than great science. It demands smart manufacturing strategy.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The journey from research to commercial scale doesn’t have to be overwhelming. With the right approach, you can navigate these challenges while staying focused on what matters most: getting revolutionary treatments to the patients who need them, and delivering them as quickly as possible.
Life sciences software and AI specialist MasterControl offers three strategies for CGT success.
Strategy 1: Standardise without compromise
Your therapies are unique, so your manufacturing approach should be too. That means your processes should be built on flexible platforms with modular components that can adapt to your specific needs. This approach lets you:
- Produce diverse or individualised therapies while maintaining consistent quality.
- Reduce variability from day one.
- Achieve right-first-time production.
- Save time and resources.
When standardisation meets flexibility, you can scale without sacrificing what makes your therapy special.
Strategy 2: Go digital, get results
Paper-based processes? In this industry? Not anymore.
Digital solutions transform how you manage production records, work instructions, and quality assurance. Companies using modern manufacturing execution solutions like MasterControl Manufacturing Excellence (Mx) are seeing:
- Review cycles shortened from days to hours.
- Drastically reduced errors and deviations.
- Faster product release through “review by exception.”
- Lower costs that make therapies more accessible to patients.
When you digitize your CGT operations, you’re not just improving efficiency—you’re creating more opportunities to change lives.
Strategy 3: Connect everything (and everyone)
Breakthrough innovation requires collaboration. Integrated systems connect your production activities with enterprise systems like enterprise resource planning (ERP) systems, manufacturing execution systems (MES), and quality management systems (QMS) for real-time data sharing that eliminates reconciliation headaches.
MasterControl’s ADAPT Platform brings quality, manufacturing, and asset management together in one place—giving you complete visibility and control over your operations. When everything connects, you can focus on innovation instead of information gaps.
Your partner on the CGT journey
CGT manufacturing comes with challenges such as:
- Data integrity concerns: Digital solutions maintain pristine data trails that stand up to regulatory scrutiny.
- Regulatory complexity: Efficient processes and robust data management support faster approvals.
- Scaling hurdles: Standardised, digital processes let you meet growing demand without compromising quality
For decades, we’ve helped life sciences companies modernise operations and maintain compliance. Our comprehensive solutions aren’t just about solving today’s challenges – they’re about future-proofing your operations for whatever comes next in the evolving CGT landscape.
Ready to transform CGT manufacturing?
The path from breakthrough discovery to lifechanging therapy shouldn’t be blocked by manufacturing limitations. By embracing standardisation and digital technology integration, you can overcome industry challenges and get innovative treatments to patients faster.
That changes everything.
Read how new guidelines ICH E6(R3) will transform quality management for CGT trials in the whitepaper from MasterControl Solutions below.
