Biologic-device bridging strategy

A biotech manufacturer sought Chimera’s advice on bridging strategy design to achieve approval of a pre-filled cartridge-injection pen following the approval of a presentation containing a similar but not identical drug formulation. Prior clinical studies had been conducted with vialed product which utilized drug-contacting materials that were different from those to be used in the manufacture of the cartridge-injection pen. Chimera assisted the manufacturer in the development of a Type C Meeting briefing document which was submitted to CDER division responsible for the regulation of the combination product. Chimera later assisted the manufacturer with interpreting FDAs written responses and planning subsequent development and submission of a sNDA.