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.
Clinical Manufacturing Overview:
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:
From the first discussion, we bring in key stakeholders to gain not only a deep understanding of the science behind your process but also your strategic goals so we can build a tailored program that scales.
Through a variety of experiments and small-scale runs performed under simulated GMP conditions, we are able to identify and correct any potential issues that could arise.
Once optimal conditions are defined through feasibility studies, our process development and analytical testing teams start working in parallel to scale the process to GMP conditions and prepare the in-process and release testing program.
GMP Production and Fill
Upstream and Downstream production process run under GMP conditions including associated in-process testing. Fill/finish operations performed on site.
Lot Release - COA
Our integrated release testing capabilities ensures we are able to meet aggressive timelines.
Product Packaging and Stability Testing
Click here to learn more about Product Packaging and Stability testing.