PROCESS DEVELOPMENT

With a strong background in processing cellular therapy products, Stemlab Advanced provides support to further improve manufacturing processes for IMPs at any stage of development. 

For any scale of production, we aim to find the best technological solution to deliver an IMP with the adequate quality for clinical development. 

We understand the importance of a robust manufacturing process for cell-based therapies and we join efforts with our clients to achieve a cost-effective process able to manufacture a reproducible and safe IMP. 

OTHER SERVICES

cGMP MANUFACTURING

Technology Transfer
Process Validation
Clinical Batch Production
Batch Release
Cryopreservation

QUALITY

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

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