We offer three levels of service for viral clearance studies.
For all levels of service, the Sponsor provides buffers, chemicals, packed chromatography resins, and materials for preliminary testing and Viral Clearance studies [with appropriate GLP labeling]. For all levels, Texcell’s team provides the selected virus panel, performs virus spiking of the starting material, and all related assays for quantitation of virus.
Level I: Classic Service
Sponsor executes the scaled-down manufacturing process at the Texcell laboratory.
Level II: Collaborative Service
Texcell personnel assist Sponsor in execution of the scaled-down manufacturing process at the Texcell laboratory.
Level III: Complete Service
The scaled-down manufacturing process is tech transferred to Texcell. Texcell personnel execute the entire study at the Texcell laboratory.
Please Contact Us for any Investigational New Drug [IND] or Biologics Licensing Application [BLA] Viral Clearance Study request.