Clinical Manufacturing for Cell and Gene Therapies
Accelerating Progress and Speed to Market
With shortened regulatory pathways for cell and gene therapies, it’s vital to select a CTDMO for clinical manufacturing that not only accelerates your time to first in human but also can support testing operations, and eventually your commercial program.
By integrating development, testing, and manufacturing, we have transformed stand-alone services into a clinical manufacturing solution that enables faster to first in human trials.
- Platform for GMP Viral Vector production
- Adherent or Suspension Production systems
- Early focus on building a robust process, synchronized Analytical Development
- Rapid characterization and release
- Dedicated suites – ensures a seamless transition from clinical to commercial
- Technical and Regulatory support
Clinical Manufacturing Program:
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GMP Production and Fill
Lot Release - COA
Product Packaging and Stability Testing
Manufacturing and Testing Facilities
Established GMP Manufacturing Capabilities
Are you preparing for late-phase and early commercial?
Not all CMOs and CDMOs are created the same. As a leading Contract Testing Development and Manufacturing Organization (CTDMO), we support: