Manufacturing services

 

 

Cell Banking: MCB/WCB

 

We offer Master and Working Cell Banking for microbial (E.coli yeasts) and mammalian cells as part of integrated development and manufacturing projects or as a unique request.

 

The characterisation of cell banks is performed by the Quality Control team in our dedicated GMP laboratory. For more details see PX'Therapeutics’ analytical solutions.

 

In compliance with GMP, we also ensure short- and long-term storage of cell banks and stability testing.

 

 

Drug Substance

 

PX'Therapeutics produces bulk drug substance for preclinical batches and phases 1 & 2 clinical-trial batches.

 

 

Drug Product/Fill & finish

 

PX'Therapeutics works with several audited GMP partners and can coordinate fill & finish operations. 
Drug-Product material will be characterised by our Quality Control team and can be certified by our Qualified Person.

 

Others

 

We can handle any other projects in a similar way to therapeutic-drug development when GMP manufacturing is required, for example with in-vivo diagnostics or ancillary-material projects, by offering suitable and relevant technical and regulatory expertise.