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Protein Therapeutic

Therapeutic protein drugs are an important class of medicines serving patients most in need of novel therapies. Applications in this therapeutic class include the bioprocessing of 
       • Monoclonal antibodies
       • Antibody fragments
       • Fc and Albumin fusions
       • Blood factors
       • Protein-based vaccines

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.

protein therapeutic process flow and Applications

 

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