Cell and Gene Therapy CTDMO

Redefining end to end solutions through integrated development, manufacturing, and testing

For cell and gene therapy companies, outsourcing manufacturing and testing operations to a capable CTDMO can reduce development timelines, provide supplementary capacity, and ultimately control costs. With an assortment of available options, how do you select the right organization?

Through continued internal reinvestment in facilities, technology, and talent combined with over three decades of biopharmaceutical testing expertise, we have transformed our services into solutions that alleviate industry bottlenecks, accelerate time to market, and support commercial programs around the world.

Fast-track time to market

Discuss timelines with our technical experts.
Your Strategic Partner: Overview of CTDMO Capabilities
Whether a startup that just spun out of an academic institution or a large pharma seeking to launch a product in new markets, our integrated development, manufacturing, and testing services can be tailored to meet your specific needs. Ideal for:

  • Viral Vectors for Gene Therapies
  • Autologous and Allogeneic Cell Therapies
  • Gene Mediated Cell Therapies like CAR-T
  • Emerging technologies like CRISPR/Cas9, Oncolytic Viruses, NK’s, and Exosomes
D in Development
Not only do we provide analytical and process development services to our clients, we are also dedicated to expanding capabilities through internal development efforts.
GMP Manufacturing Capacity
From enabling first in human to late phase clinical, all the way through commercial approval, we provide scalable GMP manufacturing capacity engineered to support the long-term success of your program.
In-Process QC and Release Testing – Integrated or Stand Alone
Refined over three decades, we offer a complete portfolio of testing services that covers the entirety of your product’s lifecycle. Designed to meet the most aggressive timelines, our testing services can be integrated into a manufacturing program or utilized as an extension of your internal testing operations.
Infrastructure to Access New Markets

When launching a product in a new market, a local CTDMO can be a significant asset. To support the second largest market, new GMP facilities in Shanghai and WuXi City will be online shortly.

PHL Campus Tour

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Over 400,000 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.

R400

Integrated Manufacturing and Testing – Est. 2020 – 140,000 sq ft

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Not sure what Manufacturing or Testing service is right for you? Speak to our experts.