GMP Manufacturing

Stemlab Advanced holds a Manufacturing Authorisation for the production of Investigational Medicinal Products (IMPs) since 2020.

 

We combine a long track record of processing, banking and releasing of cellular therapy products with a rigorous compliance with current GMP guidelines to deliver an IMP that meets our clients’ requirements and within the established timelines and budget.

Our facilities are equipped with state-of-the-art equipment prepared for multi-products manufacture for clinical trials and hospital exemptions.

 

OTHER SERVICES

PROCESS DEVELOPMENT​

Process gap analysis
Process design and optimization
Critical Quality Attributes definition
Stability testing
Comparability studies

QUALITY

Batch certification
Development and validation of analytical methods
Regulatory support for IMPD submission
Safety testing (sterility, endotoxins and mycoplasma)

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