Mark Sampson

Background

About Mark Sampson

GMP manufacturing experience for downstream operations. Introduction of single use technologies. Manufacturing Excellence implementation. Successfully led team for GMP manufacture of Phase I, Phase and Process Performance Qualification batches for purification of filgrastim. Member of team to receive FDA Approval for NYVEPRIA (Pegfilgrastim). Manufacturing process included dissolution and refolding, capture chromatography and intermediate purification with ion exchange and hydrophobic interaction chromatography steps. Concentration/diafiltration by TTF, product formulation and final 0.2um filtration under aseptic conditions. I led the execution of corresponding Process Validation studies for resin reuse (four columns at full scale), intermediate hold studies, microbial control hold points and buffer stability studies. Significant process development for monoclonal antibodies and recombinant proteins, with evaluation of different modes of chromatography including packed bed and membrane chromatography. I led the small scale process characterisation for complex molecule that reached commercialization and market approval with FDA. Experience with process characterisation, cleaning validation and resin re-use for a recombinant protein as part of process validation activities. Specialties: Downstream Manufacturing scale for recombinant proteins. Expert in column packing for compressible and non- compressible resins. Manufacturing Excellence for continuous improvement opportunities. Downstream process development and process validation for monoclonal antibodies and recombinant proteins. GMP manufacturing, process validation, equipment validation, environmental monitoring.