LFB Biomanufacturing present at BioTalk 2019 in Boston May 22nd and 23rd
LFB Biomanufacturing will be present at Biological Manufacturing Excellence congress – BioTalk 2019 – Boston May 22nd and 23rd.
David Balbuena, Head of Manufacturing, will give a presentation about validation of the Viral Inactivation by Solvent/Detergent treatment in Single Use System
Over past years , LFB Biomanufacturing progressively modified the SD inactivation step performed in Glass or Stainless steel container to Step performed in Single Use system.
The presentation give an overview of the different steps to validate those processes for implementation at Clinical Phase III stage(temperature mapping ; Homogeneity study …)
Several Case Studies are presented with Triton X100 as well as Polysorbate/TnBP mix. Some examples are presented with different system : 20L scale with rocking system, 50L and 200L scale with Magmix system. Specific scale scale-down model have been developed with the supplier for the Viral validation studies.
The presentation underlined the impact of the EU Reach regulatory authority decisions of the current treatment and the coming new solution.
Do not rely on your equipment supplier perform Prevalidation as soon as possible !
Work in collaboration with your supplier, they can bring you effective solution sharing with them your needs