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:

Technical Consultation

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.

GMP Readiness

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.

Develop, manufacture, and release your advanced therapies faster and with greater predictability.


Click below to speak to a technical specialist today