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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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
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:
