Recently approved recombinant protein therapeutics have been developed to treat a wide variety of clinical indications, including cancers, autoimmunity/inflammation, exposure to infectious agents, and genetic disorders.
Protein therapeutics development and manufacturing is a highly complex process. In both process development as well as commercial manufacturing, the protein therapeutics workflow includes cell optimization, cell culture, harvest, purification, formulation and fill and finish.
Since the products are synthesized by living cells or organisms, the choices of cell line and cell culture conditions all affect the final product characteristics, and complex purification processes are involved using filters and resins to produce the final product.
Cell line dev ►
(PD scale only)
Cell line optimization
Cell banking
Analytics
Application
Cell line optimization
Repligen solutions
Cell culture ►
Media optimization
Seed train optimization
Cell culture expansion
Process development
Analytics
Applications
Perfusion cell culture
N-1 Perfusion
Cell growth factors
Repligen solutions
Harvest ►
Centrifugation
Depth filtration
Sterile filtration
Analytics
Applications
High Productivity Harvest
Repligen solutions
Purification ►
Capture / Polish chromatography
Tangential flow filtration
Scale-down validation
Analytics
Applications
Pre-packed columns
UF/DF
Repligen solutions
Formulation ►
Tangential flow filtration
Analytics
Applications
Concentration and Diafiltration
Repligen solutions
Fill / Finish
Analytics
Applications
Concentration/Lot release
Repligen solutions