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:

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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.

Feasibility

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. Click here to learn more.

Product Packaging and Stability Testing

Click here to learn more about Product Packaging and Stability testing.

Manufacturing and Testing Facilities

PHL Campus Tour

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Over 287,000 sq ft

Global Compliance – Comprehensive Quality System – Integrated Testing and Manufacturing Operations

League Island 1

LI1 – HQ/Early Phase Clinical Manufacturing and Testing – Est. 2004 – 82,000 sq ft

LI1

In addition to early phase clinical manufacturing, testing operations such as cell line characterization, QC, and viral clearance are performed here.

Commerce Center 3

CC3 – Non-Viral Cell Therapy Manufacturing – Est. 2015 – 55,000 sq ft

CC3

For autologous cell therapies, timing is everything. Located only seven miles from Philadelphia International Airport, our campus location enables us to begin processing patient materials faster.

League Island 2

LI2 -Late Phase/Commercial Viral Manufacturing and Testing – Est. 2016 – 150,000 sq ft

LI 2

LI2’s is dedicated to late-phase and commercial manufacturing of viral vectors and gene mediated cell therapies. Additional operations include QC and release testing, fill/finish, process development, and analytical development.