Cell & Gene
Therapy CTDMO

Contract Testing, Development,
and Manufacturing Services for Advanced Therapies.

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Delivering the Future
of Medicine

We are a global contract testing, development and manufacturing organization, (CTDMO). We enable the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world. Our vision is that one day, every drug can be made, and every disease can be treated.

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Innovative and Transformative Services

For more than 20 years, we have been working with pioneers in advanced therapies to help them successfully discover, develop, manufacture and release their products for patient use.

Contract Testing

Proven analytical method development, lot release testing, viral clearance, stability, and more.

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Process Development

Expert and flexible approaches to develop, scale, and optimize your processes and methods.

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IND Enabling Studies

Optimize processes, ensure GMP readiness, and secure data required for your IND submission.

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Clinical Manufacturing

Phase appropriate approaches that accelerate timelines and ensure quality clinical production.

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Commercial Manufacturing

High-quality, high-volume capacity, infrastructure, logistics, and systems which have passed inspection.

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WuXi Advanced Therapies Plasmid Manufacturing

Our
Capabilities

Expertise
Facilities
Quality
Regulatory
Supply Chain

Modalities and Therapeutic Areas

Our experience and services cover CAR-T, T-Cell, TIL, MSC, AAV, Lenti, mAbs, Vaccines and other common advanced therapies.

Autologous
Allogeneic
Monoclonal Antibodies
Vaccines
Viral Vectors

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Tell us about your program. Connect with experts.

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Articles & Events

XOFLX Technology Undergoes Peer Review: Published in Molecular Therapy Clinical Methods & Development

To launch a successful GMP program for biologics, a robust quality control (QC) release testing protocol is essential. QC testing, which is mandated by global regulatory authorities, helps ensure that a product meets scientific specifications and reaches patients safely. Though each program will have unique parameters, QC testing should gather data to answer the following questions:

Oct 7
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Cell & Gene Meeting On The Mesa 2024
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