Our facility holds current GMP manufacturing licenses and is authorized to supply cell and gene therapies to multiple PIC/S-compliant jurisdictions. We maintain alignment with evolving global regulatory expectations to ensure consistent compliance and patient safety.
Six Gates to Go-Live
Our facility holds current GMP manufacturing licenses and is authorized to supply cell and gene therapies to multiple PIC/S-compliant jurisdictions. We maintain alignment with evolving global regulatory expectations to ensure consistent compliance and patient safety.
CTPL TO ADD COPY
Why Cell Therapies' Technology Transfer Works
Digital Twins & Augmented Reality Walk‑Throughs cut sponsor travel 80%
Core Technology Transfer Team: Process Development, Quality Assurance, Quality Control, Supply‑Chain, and Digitalization
Regulatory Harmonization: Common Technical Document (CTD) Module 3 author support, bridging regulators
Change‑Control Discipline lock Critical Quality Attributes (CQA) & maintain global comparability
cell therapies is an Australian-based, globally-active commercial contract development and manufacturing company, specializing in cell therapy, gene therapy, regenerative medicine, and cellular immunotherapy products
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Corporate
Victorian Comprehensive Cancer Centre
Level 9, 305 Grattan Street,
Melbourne, VIC,3000
Australia
+61 3 9492 4777
[email protected]
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